Example Report: Pro QC

Transcription

ISO/TS 16949 Audit Report
* Example Report *
North America
+1-813-252-4770
Latin America
+52-1-333-2010712
Europe & Middle-East
+49-8122-552 9590
Asia & Asia Pacific
+886-2-2832-2990
Email
info@proqc.com
www.proqc.com
ISO/TS 16949 Quality Management System Audit
Rev.
GUIDELINES
0
PURPOSE:
This audit checklist was created based on requirements defined in the following standards:
- ISO/TS 16949 standard
- AIAG Standard
The intent of the audit is to assess the compliance level of suppliers to these requirements, and to provide adequate
information to the client for use in business decisions.
SCORING:
Scores are assigned based on what is done for the Pro QC client regardless of what is done for other clients. For
example, if control plans are developed for other clients but not for the Pro QC client, the score must be NC. Scoring
must be explained to the supplier at the opening meeting.
Complies with the Requirements = C
Improvement Needed = I
Non-Conformance Found = NC
N/A = Does Not Apply
GUIDELINE FOR SCORING CONFORMANCE:
Each question is assessed for conformance to the requirements of the applicable standards, and the auditors
knowledge of the product and/or process This must be clear to the supplier at the opening meeting.
Complies with Requirements =
- Has objective evidence to support the question, and
- Has a written procedure (when required).
Improvement Needed =
- Has objective evidence, but procedure needs improvement.
- Has objective evidence, but no written procedure.
- Has written procedure, but is lacking some objective evidence to support the question.
Non-Conformance =
- No objective evidence to support the question (regardless of the procedure).
- Lacking some objective evidence and no written procedure.
RESULTS/RECOMMENDATIONS: (Automatically Calculated)
The score is based on the percent of questions that Complies with Requirements, percent that Needs Improvement,
and the percent that have a Non-Conformance. Each client should review how the supplier was evaluated for each
question and base their decisions on factors that are important to their organization and product(s).
AUDIT REPORT:
The following sections are completed by the auditor:
- Scope of the Audit
- Recommendations
- Strengths of the Supplier's Quality System and Manufacturing Process
- Opportunities for Improvement (Weaknesses in the Supplier's Quality System and/or Manufacturing Process)
RESULTS REVIEW WITH SUPPLIER:
The auditor should review the audit results with the supplier, but cannot provide the supplier a copy of the audit. The
audit is the property of the client.
CORRECTIVE ACTIONS:
It is recommended that the client request a corrective action (improvement plan) based on the results of the audit. The
improvement plan should include the following:
- Detailed description of action plan.
- Name of the person responsible for the improvement activity.
- Date when the improvement will be completed.
ISO / TS 16949 QMS Audit Form
Rev.
SUMMARY
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
SUPPLIER'S INFORMATION
CLIENT'S INFORMATION
NAME : XXXXXXXXXXXXXXX
ADDRESS : XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
CITY : XXXXXXXXXXXXXXX
COUNTRY: XXXXXXXXXXXXXXX
PHONE : XXXXXXXXXXXXXXX
FAX : XXXXXXXXXXXXXXX
NAME : XXXXXXXXXXXXXXXXX
ADDRESS : XXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXX
CITY : XXXXXXXXXXXXXXXXX
COUNTRY: XXXXXXXXXXXXXXXXX
PHONE : XXXXXXXXXXXXXXXXX
FAX : XXXXXXXXXXXXXXXXX
SUPPLIER'S PERSONNEL PARTICIPATING
Mr./Mrs.
Mr./Mrs.
Mr./Mrs.
Mr./Mrs.
XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
Title:
Title:
Title:
Title:
Title:
Mr./Mrs.
XXXXXXXXXXXX
XXXXXXXXXXXX
XXXXXXXXXXXX
XXXXXXXXXXXX
Email:
Email:
Email:
Email:
Email:
XXXXXXXXXXXXXX
XXXXXXXXXXXXXX
XXXXXXXXXXXXXX
XXXXXXXXXXXXXX
Email:
Email:
XXXXXXXXXX
XXXXXXXXXX
Pro QC Personnel
Mr./Mrs.
Mr./Mrs.
XXXXXXXXXXXXXX
XXXXXXXXXXXXXX
Title:
Title:
XXXXXXXXXX
XXXXXXXXXX
AUDIT RESULTS =
Category
Complies ( C )
Needed
Improvement ( I )
Not-complies
(NC)
Not Applicable
(N/A)
92.93%
4. QUALITY
8 MEASUREMENT, ANALYSIS
7. PRODUCT
AND 6.
IMPROVEMENT
RESOURCE
REALIZATION
5. MANAGEMENT
MANAGEMENT
RESPONSIBILITY
MANAGEM
4. QUALITY MANAGEMENT SYSTEM
ENT
96.5%
91.67%
88.46%
91.89%
96.77%
5. MANAGEMENT RESPONSIBILITY
6. RESOURCE MANAGEMENT
3.5%
7.58%
11.54%
8.11%
3.23%
0.0%
0.76%
0.00%
0.00%
0.00%
1.8%
12.12%
0.00%
0.00%
0.00%
7. PRODUCT REALIZATION
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
0%
Complies)()C)))
10%
20%
Needed)Improvement)()I)))
30%
40%
50%
60%
70%
Not3complies)(NC))
RECOMMENDATIONS
1
2
3
4
The system is well documented and implemented effectively. You could start or
continue business with this supplier.
The system is acceptable, with minor nonconformities noted. You could use this supplier
and keep pushing them for improvement.
System has several major issues noted. You could temporarily use this supplier and
request immediate corrective action in case of long-term business.
There are serious majors issues noted with this supplier that could impact your business.
This supplier will need significant time and resources to be compliant to requirements.
The best solution will be to source another supplier.
80%
90%
100%
ISO/TS 16949 QMS Audit
Rev.
AUDIT REPORT
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
Scope of Audit:
To evaluate the Quality Management System of the supplier.
Summary / Recommendations:
The audited factory is located in XXXXXX. The factory has approximately 500 to 600 people working full-time.
There are two various productions, with one already certified to ISO/TS 16949.
Tthe 2nd, XXXXXXXX, is ongoing in the process to be included in this certification before the end of this current year.
There is sufficient evidence demonstrating that the audited site has an effective QMS functioning according
to requirement of TS, with staff well trained in the maintenance of QMS. The factory has experience working with
world class track maker and various others clients which has enhanced to keep themselves at
the international standard level. The auditor has full confidence that this organization has enough capability to
overcome few improvements listed here below in order to further reduce quality risk.
Strengths:
1. The factory is TS certified, with the system controlled by well qualified people / auditors (12).
2. The people in charge of QM has clear understanding of PDCA and have evidences of their implementation.
3. Visualizing system to communicate with worker in the clear language of the importance of client.
4. Great history of cooperating with major world-class clients.
5. Adequate manufacturing area, well spaced and in good working condition.
6. Testing center with necessary equipment in place and calibrated, with tags.
7. Multi-functional team applied in the development of process (APQP / PPAP).
8. Excellent supplier management / control, with one supplier TS certified, two committed to complete within a couple
of months, 13 out of 21 ISO 9001 certified.
Opportunities for Improvement:
1. Quality objectives: KPIs should be updated and published on a monthly basis at various workshops.
2. Competence of people: Skill matrix should be defined and published at testing center.
3. Human resources: Must have a replacement staff, when key people are not available.
4. Management review input: Use PFMEA as input during management review meeting.
5. Predictive maintenance: Tool life circle time to be defined in the tooling CV.
6. Control of changes: Must specify a list documents that could be affected by specific changes.
7. Calibration: Should have a calibration program with an alert sign when approaching the expiration date.
8. Calibration: Internal calibration to be traceable to external source.
9. Recording: In-house calibration to be recorded by hand, not in the computer.
10. Calibration: Employees must have a plan when an equipment is found out of calibration or damaged.
11. Testing method: Could provide specific work instruction for some testing devices with images.
12. TS Certification: The organization should submit a plan for the completion of the TS certification of the
2nd facility to client, and keep them updated on the progress.
ISO/TS 16949 QMS Audit Form
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES
4
EVIDENCE TO CHECK
FINDINGS
QUALITY MANAGEMENT SYSTEM
4.1
General Requirements
Has the organization established,
Evidences of this question can be demonstrated
documented, implemented and
throughout the audit.
maintained a QMS and continually
improved its effectiveness in accordance
with ISO/TS 16949:2009?
Yes, the organization has established,
documented, implemented and maintains a
QMS according to ISO / TS requirements
(Exclude 7.3), and has evidences of
continually improving its effectiveness.
4.1q2a
Has the organization identified the
processes needed for the QMS and their
application throughout the organization?
[ISO/TS 16949:2009, Art 4.2.2]
Yes, the organization identified the
processes needed for the QMS, in their
Quality Manual (Q/YCQP1001-2011, page
14/36), and their application throughout the
organization. SEE PHOTO #2.
4.1q2b
Has organization determined the
sequence and interaction of QMS
processes?
[ISO/TS 16949:2009, Art 4.2.2]
Yes, the organization determined the
sequence and interaction of processes in
the Quality Manual (Q/YCQP1001-2011,
page 15/36). SEE PHOTO #3.
4.1q2c
Has the organization defined criteria and
methods to uses to ensure that the
operation and control of QMS processes
are effective?
Yes, the organization applies the approach
of PDCA to monitor performance of
processes for effectiveness. Each process
has procedures and guidelines and with
defined KPIs.
4.1q2d
Has the organization provided resources
and information needed to support the
operation and monitoring of QMS
processes? (See Section 6)
Yes, resources are provided, with qualified
operators under an organization chart and
with adequate two facilities, with necessary
equipments. SEE PHOTOS #4, #5 & #6.
Does the organization monitor, measure
and analyze QMS processes? (See
Section 8)
Yes, each process identified has specific
KPI, with responsibility for their monitoring,
for improvement, as general KPI and as
KPIs distributed to each process and
department. It should the status of
satisfaction for the year 20XX, and planning
for the year 20XX. SEE PHOTOS #7 AND
#8.
4.1q1
4.1q2e
4.1q2f
4.1q3
C
C
C
C
C
C
Does the Organization implemented
actions necessary to achieve planned
results and continual improvement of
processes needed for the QMS?
Yes, the Organization has evidences of
implementation of continual improvement
thought effective management review
C
Are processes needed for the QMS
managed by the organization in
accordance with the requirements of
ISO/TS 16949:2009?
When the organization outsources any
process that affects product conformity
with requirements, how is control
ensured over such processes? (See 7.4)
Yes, processes are managed with KPIs.
SEE PHOTOS #7 and 8.
C
4.1q4
4.1q5
SCORE
Where is the control of outsourced
processes that affect product conformity
with requirements identified within the
QMS? (See 7.4)
The organization purchases few
components from others suppliers, and gets
support from external service for calibration
of equipment. All of these external
outsources are managed according to the
requirements of the Purchase Procedure
(Q/YCQP2019-2011).
It is identified in the purchase.
C
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
T4.1.1q1
4.2
4.2.1q1a
4.2.1q1b
4.2.1q1c
4.2.1q1d
4.2.1q1e
4.2.2q1b
4.2.2q1c
SCORE
C
Documentation Requirements
a) Review where it's written and note the doc, if
any.
b) Check if the QP/QO posted in a visible place
for all employee to view.
c) Take a photo.
Yes, the Quality Policy is documented in
the Quality Manual (Q/YCQP1001-2011, rev
C), published and signed by GM. SEE
PHOTO #9. Quality objectives are also
listed, with a distribution to each
department. SEE PHOTO #7.
Does Organization have a quality
manual? ISO/TS 16949:2009, Art
4.2.1(b)
Review the Quality Manual, and note the doc.
and rev.
Yes, the factory has a Quality Manual 20XX
(Q/YCQP1001-2011, rev C) published in 2009-30.
Does the organization have the
documented procedures required by ISO
9001:2008?
ISO/TS 16949:2009, Art 4.2.1(c)
a) Review the procedure master list and confirm Yes, the factory has about 26 procedures as
that all mandatory procedures are included.
guidelines for the implementation of QMS
b) Take a photo of the master list.
according to TS requirements, listed in QM,
page 35/36. SEE PHOTO #10.
Are adequate documents in place to
ensure the effective planning, operation
and control of t organization’s
processes?
ISO/TS 16949:2009, Art 4.2.1(d)
Does documentation include the records
required by ISO 9001:2008?
ISO/TS 16949:2009, Art 4.2.1(e)
Evidences of this question could be
demonstrated throughout the audit.
Yes, documentation is visible at each place
as guideline.
a) Review the master list for record and confirm Yes, the factory has procedure for the
that all records monitored are included.
control of record (Q/YCQP2013-2011, Rev.
b) Take photo of the master list.
B/0.) There is a master list of ten pages
describing all Quality Record to save,
including saving place, and time. SEE
PHOTO #11.
C
C
C
C
C
Quality Manual
If any, is the scope of the quality
management system identified in the
QMS, including details of and
justification for exclusions?
ISO/TS 16949:2009, Art 4.2.2(a)
If any justification for exclusions, then note the
page of QM in which is written.
Does the quality manual (QM) contain or
reference the documented procedures
established for the QMS?
ISO/TS 16949:2009, Art 4.2.2(b)
Check if doc numbers of procedures are written Yes, the QM contains references of
at relevant section of the QM to indicate
procedures/documents to use. The name of
appropriate procedure applied.
the procedures are written as link.
Does the quality manual include a
description of the interaction between
the processes of the QMS?
ISO/TS 16949:2009, Art 4.2.2(c)
a) Check if there a document in annex of QM or
out of the QM, as document describing
interaction between processes.
b) Take photo of the map.
Are the documents required by the QMS
controlled?
ISO/TS 16949:2009, Art 4.2.3
a) Ask if there is a master list containing all
documents for QMS, with doc title, current
revision and distribution record / name of users.
b) Select few docs from the master list, and
cross check on site (user hands) if these docs
have same doc. nb, rev. nb, and accurate nb of
copy distributed.
4.2.3
4.2.3q1
FINDINGS
Yes, incoming inspections are conducted
per random sampling. Suppliers are
selected per requirement, and are
evaluated on an annual basis.
Does the organization have documented
statements of a quality policy (QP) and
quality objectives (QO)?
ISO/TS 16949:2009, Art 5.3, 5.4.1
4.2.2
4.2.2q1a
EVIDENCE TO CHECK
Does the organization have adequate
control over outsourced processes to
ensure conformity to all customer
requirements?
(See 7.4)
Yes, the scope of the QMS is described in
the TS certification, with exclusion of 7.3,
See page 10/36, where it declared to
exclude 7.3, 7.3.2.1, 7.3.3.1.
Yes, there is process map described in the
QM page 14/36, with five Customer related
processes (C1, C2, C3, C4), supporting
processes, and management processes,
including their relation in page 15/36 of the
QM. SEE PHOTOS #2 & #3.
C
C
C
Control of Documents
Yes, there is procedure for the control of
document (Q/YCQP-2012-2011). Checked
mold maintenance document (Q/YCQP3007-01-20XX) distributed in 20XX-03-13,
and has signature of related department.
Record are written in form (Q/YCQP-401202, A/0).
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
4.2.3q2a
4.2.3q2f
4.2.3q2g
Is there a documented procedure that
defines the controls needed for approve
INTERNAL documents for adequacy
prior to issue?
ISO/TS 16949:2009, Art 4.2.3
T4.2.3.1q2
T4.2.3.1q3
FINDINGS
defines the controls needed for ensure
that documents of EXTERNAL origin are
identified and their distribution
controlled?
ISO/TS 16949:2009, Art 4.2.3
a) Ask if there is a masterlist containing all
documents for QMS, with doc title, doc. Nb.
Current revision. And distribution record / name
of users.
b) Select few docs from the masterlist, and
cross check on site (User hands) if these docs
have same doc. nb, rev. Nb, and accurate nb of
copy distributed.
Yes, the is requirements for the control of
external documents (Q/YCQP-2012-2011,
step 6.8). There is a masterlist of external
document written in form (Q/YCQP-401207, a/1). An obsolete stamp is putted in the
drawing for identification. SEE PHOTO #12
of drawing Nb. SA14056-D as example.
defines the controls needed for prevent
the unintended use of obsolete
documents, and to apply suitable
identification to them if they are retained
for any purpose?
ISO/TS 16949:2009, Art 4.2.3
a) Ask the responsible to explain how to prevent
the use of obsolete documents.
b) Check
if there is a documented procedure for:
- Identification of obsolete doc.
- Retention period and location
c)
Note the doc nb. and current rev. in this report.
Yes, there are requirements for the control
of external documents (Q/YCQP-20122011, step 6.8). There is a master list of
external documents written in form
(Q/YCQP-4012-07, a/1). An obsolete stamp
is putted in the drawing for identification.
SEE PHOTO #12.
Is there any evidences of how to easily
identify obsolete documents to prevent
them for unintended use?
ISO/TS 16949:2009, Art 4.2.3
a) Check if there is visible "UNDER CONTROL" Yes, document has OBSOLETE stamp
stamp on new revised doc, and if there is
putted in the drawing, SEE PHOTO #12 of
"OBSOLETE" stamp on old rev. of same doc.
drawing Nb. SA14056-D as example.
b) Note doc. Nb reviewed and take photo of
those stamps if any.
Does the company have a process to
assure the timely review, distribution and
implementation of customer
specifications and changes?
Does it meet customer-required
schedule(s)?
ISO/TS 16949:2009, Art 4.2.3.1
a) Check if this process is included in any
document, note its doc. nb and rev.
b) Check if FMEA, Control Plans…etc are
included as potential document to review as per
customer-required schedule(s).
Yes, the company has a process (SP1) with
detail described in the procedure
(Q/YCQP2012-2011, section 6.8) for update
and timely distribution of updated customer
specification and changes.
It does not have clarification of what others
documents could be affected by specific
changes.
Does the review occur in two weeks or
less?
ISO/TS 16949:2009, Art 4.2.3.1
Check if the company includes time spent to
implement.
Yes, the requirement to complete the
review and distribution is been defined for
two weeks in the (Q/YCQP2012-2011,
section 6.8.2)
What records do you have showing
implementation dates of changes? Is
there evidence showing that documents
are updated? ISO/TS 16949:2009, Art
4.2.3.1
a) Check if the company maintains a record of Yes, records are available.
changes in engineering specifications from
customers or regulatory or industry documents?
b) Randomly select two cases from the list, and
ask them to show you record of implementation
of such changes in others documents (ie
FMEA, Control Plans...etc).
4.2.3.1
T4.2.3.1q1
EVIDENCE TO CHECK
a) Ask for the procedure of document control,
Yes, it described in the procedure (Q/YCQPand note its doc. nb and current revision in the 2012-2011), step 6.2. The authority
report.
regarding document review and approval is
b) Check if this procedure contain clear
defined in the procedure (Q/CYQP-2012requirements need for:
- 2011, B/0) page 6/6.
Ensuring the legibility and identification
- Authorities for approve prior to issue
Ensure that only latest rev. at workplace
- Ensure the identification of changes
SCORE
C
C
C
C
Engineering Specifications
I
C
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
4.2.4
4.2.4q1
4.2.4q2
4.2.4q3
T4.2.4.1q1
Are records legible, readily identifiable
and retrievable?
ISO/TS 16949:2009, Art 4.2.4
5.1q1c
5.1q1d
5.1q1e
T5.1.1q1
a) Check if the company has a masterlist that
with all quality records with detail of:
- Name / template nb.
- Creation method (handwriting / elec)
- Resp. for initiate and approve.
- Retention period / location
- Saving form (in paper or electronic)
- Disposal method after expiration.
b) Take photo of the masterlist
SCORE
Should be reviewed throughout the audit.
The company has a masterlist of records
that must be maintained in the factory, with
details of their location and retention period,
SEE PHOTO #11.
C
Yes, records are available
C
Does Organization have a documented
procedure defining the controls needed
for the identification, storage, protection,
retrieval, retention time and disposition
of records?
ISO/TS
16949:2009, Art 4.2.4
Review the procedure and note its doc. nb and Yes, the procedure (Q/YCQP2013-2011)
current revision.
provide guidelines for the control of records
listed in the masterlist.
Have the record requirements been
reviewed to ensure conformance with
regulatory and customer requirements?
ISO/TS 16949:2009, Art 4.2.4.1
Should be reviewed throughout the audit.
Yes, records are to be review by a
Review few records at every process to see if supervisor, with signature as conformity.
there is signature / name of the operator and for
the reviewer and approver.
5
5.1q1b
FINDINGS
Control of Records
What records exist that provide evidence
of conformity to requirements and of the
effective operation of the QMS? (Should
be reviewed throughout the audit)
ISO/TS 16949:2009, Art 4.2.4
C
C
MANAGEMENT RESPONSIBILITY
5.1
5.1q1a
EVIDENCE TO CHECK
Management Commitment
Does top management communicate the
importance of meeting customer and
statutory and regulatory requirements to
the organization?
a) Review records (with attendance) of meeting
held by top management.
b)
Review records of meeting related to any new
project.
Yes, the communication of customer will be
communicated to members following the
APQP process, to be checked during
product/ process realization, with record
attached.
Has a company quality policy (QP) been
established? (See 5.3)
a) Check if there QP documented, hand signed
by top management.
b) Check if QP is posted in public board for all
employees to view. And, eventually take a
photo of it.
C), published and signed by GM. SEE
PHOTO #9.
Has company established quality
objectives and communicated all
members? (See 5.4.1)
a) Check if the quality objectives are hand
signed by all managers and published.
b) Ask them to explain and demonstrate that
quality objectives are aligned to fit with policy.
Yes, quality objectives are also listed, with a
distribution to each department. SEE
PHOTO #7.
Does top management conduct
management reviews? (See 5.6)
a) Check if there a documented as guideline to
conduct management reviews, and note the
doc. nb / rev.
b) Review record of last two management
reviews.
Yes, the factory has a procedure for
management review (Q/YCQP-2016-2011,
B/0). The last management review was
conducted in 20XX-12-21. There is a form
for plan. (Q/HLQP-4016-01)
a) Manpower list at each position
b) Machine and facility
The factory does not have a replacement
person for lab testing.
Does top management ensure the
availability of resources to support and
continually improve the QMS?
Does top management review product
realization and support processes to
ensure effectiveness and efficiency?
(5.6?)
Yes, the factory uses a multi-functional
team, with a delegate to supervise the
process. Records are available.
C
C
C
C
I
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
5.2
5.2q1
5.3q1b
5.3q1c
5.3q1d
5.3q1e
a) Check if there is any responsible person or
group dedicated for identification of customer
requirements.
b) Check if there any records showing a list of
identified requirements per customer, and
related procedures or method applied to fit
them.
Does the quality policy include a
commitment to comply with
requirements and continually improve
QMS effectiveness?
Read the quality policy.
Are the contents of the quality policy
relevant to the organization and
measurable?
Read the quality policy and ask them to explain Yes, the contents of the quality policy
how the company measures them.
relevant to this factory are measurable with
KPIs defined, SEE PHOTOS #7 AND #8 for
the year 20XX. There is plan of how these
KPIs are monitored. SEE PHOTO #8.
Is the quality policy communicated and
understood within the organization?
a) Check if there is QP documented and hand
signed by top management.
b) Check if QP is posted in public board for all
employees to view.
Is there an established process to review
the quality policy for continuing
suitability?
Has top management established quality
objectives (including those needed to
meet requirements for product) at
relevant functions and levels within the
organization?
Are the quality objectives consistent with
the quality policy? What are the
measurements?
Are quality objectives and metrics
included in the business plan?
5.4.2
Yes, the quality policy is well appropriate,
and applicable to their facility.
Yes, the quality policy includes a
commitment to comply with requirements
and continually improve QMS effectiveness.
C), published and signed by GM, posted in
published place visible by all. SEE PHOTO
#9.
C
C
C
C
C
Planning
5.4.2q1a
C
Yes, from management review meeting.
Quality Objectives
T5.4.1.1q1
SCORE
Quality Policy
Read the quality policy.
5.4
5.4.1q2
Yes, the company has nominated a
responsible party to act as Customer Rep.
with responsibility to ensure that customer
requirements are determined. SEE PHOTO
#13. (Q/YCQP1001-2011, page 5/36).
The factory also maintains a record
describing all customer requirement
records. (Q/YCQP-4003-32-2012) SEE
PHOTO #14.
Does top management ensure that the
quality policy is appropriate to the
purpose of the organization?
5.4.1
5.4.1q1
FINDINGS
Customer Focus
Has top management ensured that
customer requirements are determined
and met with the aim of enhancing
customer satisfaction?
5.3
5.3q1a
EVIDENCE TO CHECK
Check if the quality objectives are hand signed Yes, quality objectives are also listed, with a
by all managers and published.
distribution to each department. SEE
PHOTO #7.
a) Ask them to explain how quality objectives
are aligned to fit with quality policy.
b) Review record of measurement of last year,
and for this year.
c) Check if the result are published and take a
photo of quality objectives.
C
Yes, the quality objectives are consistent
with the quality policy. SEE PHOTO #8.
C
Check if the quality objectives are hand signed Yes, it is included. SEE PHOTO #8.
by all managers and published.
C
Quality Management System Planning
Does the company ensure that the
planning of the QMS is carried out in
order to meet the requirements given in
ISO /TS 16949:2009 section 4.1, as well
as the quality objectives?
Yes, the factory uses the strategy of internal
audit, process audit, and product audit to
monitor the effectiveness of QMS as input
for management review.
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
5.4.2q1b
How do you ensure that the integrity of
the QMS is maintained when changes to
the QMS are planned and implemented?
5.5
T5.5.1.1q1
T5.5.1.1q2
T5.5.1.1q3
5.5.2q1a
5.5.2q1b
5.5.2q1c
T5.5.2.1q1
T5.5.2.1q2
SCORE
C
Responsibility and Authority
Are responsibilities and authorities
defined and communicated within the
organization? (Verify throughout audit)
a) Check the organization chart and take photo.
b) Check if there is detailed job description for
every position within the organization.
c) Check if there is a planning for replacement
in the absence of key person, and related
training record / qualifications.
Yes, there is an Organization Chart in the
Quality Manual (Q/YCQP1001-2011, page
6/36) and detail of job description in pages
8/36, 9/36. However, there is no document
detailing replacement people in the event of
the absence of a key person, for example at
the Testing Center.
Are managers responsible for corrective
action informed of nonconforming
products or processes?
Are they informed in a timely manner?
a) Check if there a document that describes the Yes, it is implemented accordingly and
flow for the communication of quality issues,
records are available.
and note the doc. nb / rev.
b) Check if a record of internal / external
complaints are maintained.
Do personnel responsible for product
quality have the authority to stop
production to correct quality problems?
Review JD for Quality Manager / Supervisor
and check if this is included.
What personnel on each shift have
responsibility for ensuring product
quality?
Check if there is a representative of the Quality Yes, each facility under this organization
Department in charge of quality for the whole
has responsibility of quality to ensure the
company. Note his/her name.
quality of product.
Is there a ISO/TS 16949 Management
Representative (MR)?
Check if there is nomination letter and take
photo.
Does the MR have responsibility and
authority to ensure that processes
needed for the QMS are established,
implemented and maintained?
Does the MR have the responsibility to
report to top management on the
performance of the QMS and any need
for improvement?
Review JD for MR and check if this is included. Yes, it is included.
5.5.2
5.5.2q1
FINDINGS
Yes, following the procedure (Q/YCQP20102011), with responsibility under Manager of
Technical Department.
Responsibility, Authority and Communication
5.5.1
5.5.1q1
EVIDENCE TO CHECK
a) Check if there is a document as guideline to
handle any changes that could potentially
happen, note doc. nb / rev.
b) Check if the company has a reaction plan
with responsible for implementing changes.
I
C
Yes, it is defined in the JD of the Quality
Department, No. 9.
C
C
Management Representative
Does the MR have the responsibility to
ensure the promotion of awareness of
customer requirements throughout the
organization?
Has top management designated as
Customer Representative to ensure that
customer requirements are addressed?
Does their responsibility and authority
include selection of special
characteristics, setting quality objectives
and related training, corrective and
preventive actions, product design and
development?
Yes, it documented in the QM, page 4/36.
Mr. XXX is nominated as Management
Representative.
C
C
a) Review the organization chart and the
position of MR, including report line.
b) Review his last report submitted to top
management (Is this signed by the MR?)
Yes, it is included.
C
Review JD for MR, and check if this is included. Yes, it is included.
c
Check if there is nomination letter, take photo of Yes, it is defined in the QM, page 5/36.
that letter.
Review JD for customer representative and
check if this is included.
C
Yes, it is included.
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
5.5.3
5.5.3q1
5.6.1q2
5.6.1q3
T5.6.1.1q1
T5.6.1.1q2
T5.6.1.1q3
SCORE
C
Management Review
What kinds of information are reviewed
in management reviews? (Must include
suitability, adequacy and effectiveness of
QMS; improvement; & changes to the
QMS, quality policy and objectives)
Check the scope of management review
suitability, adequacy and effectiveness of QMS;
improvement; & changes to the QMS, quality
policy and objectives.
Can you show me records from recent
management reviews?
Check records of last two management reviews Yes, reviewed the record of last
and compare status of improvement between
management review conducted in 20XX-12both.
22.
Do management reviews include all
requirements of the quality management
system and performance trends? (Verify
records)
Verify records of last two management reviews. Record of review are checked for the year
20XX. Performance trends of the year 20XX
recorded in document ( Q/YCQP-4016-05,
B/0).
Can you show management review
records including monitoring of quality
objectives, and cost of poor quality
metrics? (Verify records)
Verify records of last two management review.
Can you show records providing
evidence of achievement of the quality
objectives specified in the business plan,
and customer satisfaction with product
supplied?
Verify records performance of each objectives
and take photo.
Can you show me that each of the
following were included in review(s)?
a) Verify if there is document specifying the type Yes, all inputs are included in the file
of input for the management review and note
Q/YCQP-4016-03 (a/0).
the doc. nb/ rev.
b)
Verify if all mandatory inputs are listed, and
include evidences for the last two management
review meeting.
According to the last management review
conducted in 20XX-12-21, following are
reviewed written in Q/YCQP-4016-03 (a/0):
- Policy and objective
- Last internal audit record
Improvement opportunity
C
C
C
C
Yes, recorded in the form Q/YCQP-401605, B/0)
C
Record are available. SEE PHOTO #16.
C
Review input
Do records show input to management
review includes analysis of actual and
potential field-failures and their impact?
(See also 7.3.4.1)
5.6.3
5.6.3q1
The method of communication is defined in
related procedure, and change depending
to the type of information. Email, ERP
system mainly is used, including public
board, to inform about performance. SEE
PHOTO #15.
Check if it documented to conduct management It is written in the procedure that the
review at least one time per year and in specific management review will be conducted one
circumstances. Note the doc. nb / rev.
time per year.
a) results of audits,
b) customer feedback
c) process performance and product conformity
d) status of preventive and corrective actions
e) follow-up actions from previous management
reviews
f) changes that could affect the quality management
system, and
g) recommendations for improvement
T5.6.2.1q1
a) Check if the company has defined clear
methods (email, fax, telephone, meeting, paper
record) for communication of information.
b) Check if the implementation of these are
effective and their efficiency monitored (On time
delivery, accuracy).
What is the frequency that top
management reviews the organization's
QMS?
5.6.2
5.6.2q1
FINDINGS
Internal Communication
How is information regarding the
effectiveness of the QMS communicated
within the organization?
5.6
5.6.1q1
EVIDENCE TO CHECK
C
Did not include PFMEA as input to
management review.
I
Review Output
What decisions or actions have resulted
from management reviews for each of
the following?
a) improvement of the effectiveness of the quality
management system and its processes
b) improvement of product related to customer
requirements, and
c) resource needs
a) Verify if there is document specifying the type Yes, decision of output are listed in the form
of output for the management review, note the Q/YCQP-4026-02 (a/0).
doc. nb/ rev.
b)
Verify if all mandatory outputs are listed, and
with evidences for the last 2 management
review meeting.
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
6
6.1q1b
Review factory profile.
What resources has the organization
provided to ensure that customer
requirements are met?
(See 6.2, 6.3, 6.4)
Evidence on question (See 6.2, 6.3, 6.4) will be The factory has all necessary workshops,
acceptable.
and equipment, including lab service. SEE
PHOTOS #5, #6, AND #17. TESTING
CENTER - SEE PHOTOS #18, #19, #20,
#21, #22.
6.2.2q1c
6.2.2q1e
T6.2.2.1q1
T6.2.2.1q2
T6.2.2.2q1
C
C
General
What are the education, training, skills
and experience required by this
job/task?
How does this person meet those
qualifications?
a) Verify of the factory has skill matrix defined
for key personnel.
b) While auditing, select some personnel
performing work affecting product quality.
How do you determine the necessary
education, training, skills and experience
for people performing work affecting
product quality?
Verify if the factory has system for identification The factory has procedure (Q/YCQP2017of training need.
2011) for guideline for the identification of
training. Training are for new hiring people
and for annual training.
What training or other actions do you
provide to satisfy the needs of
personnel?
a) Verify if a periodical (annual) training plan is
documented.
b) Take a photo of the training program.
When you provide training or other
actions to satisfy competence needs,
how do you evaluate the effectiveness of
those actions? (records)
a) Verify if there is method for evaluating
The method of evaluation is defined in the
effectiveness of training provided, and name of file (Q/YCQP-4017-14-2012). SEE PHOTO
examiner.
#26.
b) Verify of the trainer is the same peron that
conduct evaluation.
Where do you maintain records of
education, training, skills and
experience?
Select three training topics from the training
program, and verify if related training records
are available and fit with the program.
What tools and techniques has the
organization identified as necessary for
product design personnel?
a) Verify if Autocad, Pro/E…ERP system or any The factory has identified specific design
similar system is applied for design personnel. software such as PRO / E, Autocad and
b) Note revision number of those design tools. solid work.
What records do you have showing that
product design personnel are competent
to design and are skilled in the identified
tools and techniques?
Verify design personal skill matrix and related
certificate / training record.
6.2.2
6.2.2q1b
The factory provided manpower resource
for the QMS, and ERP system for internal
communication, etc.
Human Resources - General
6.2.1
6.2.2q1a
SCORE
Provision of Resources
What resources has the organization
provided to implement and maintain the
QMS and continually improve its
effectiveness?
6.3
6.2.1q1
FINDINGS
RESOURCE MANAGEMENT
6.2
6.1q1a
EVIDENCE TO CHECK
The factory has defined skill matrix for each
level of employee, documented in the file
(Q/YCQP-4017-14-2012). SEE PHOTO
#24.
C
Competence, Awareness and Training
Can you show me documented
procedures for identifying training needs
and achieving competence of all
personnel performing activities affecting
product quality?
There is an annual training program
documented in the file (Q/YCQP-4017-142012) for the year 20XX, and approved by
the leader in 20XX-01-07. SEE PHOTO
#25.
C
C
C
Yes, records are available. SEE PHOTO
#27.
C
Training of technical people has been
planned in the document (Q/YCQP-4-17-142012) for the current year, for Autocad,
GB2828, ERP system, SEE PHOTO #28.
No record to attest the capability of
employee having skill in PRO / E. for
example.
C
I
Check the existence of the procedure, and note Yes, the record of training are available in
doc. nb / rev.
the document (Q/YCQP-4017).
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
T6.2.2.2q2
T6.2.2.3q1
T6.2.2.3q2
T6.2.2.4q1
T6.2.2.4q2
T6.2.2.4q3
EVIDENCE TO CHECK
FINDINGS
a) Verify record of training / certificate of
personnel performing key process (for
example).
b) Verify record of training / certificate of
personnel for specific client requirement, note
the specific client is possible.
Training of technical people has been
planned in the document (Q/YCQP-4-17-142012) for the current year, for Autocad,
GB2828, ERP system. SEE PHOTO #28.
No record to attest the capability of
employee having skill in PRO / E, for
example.
What kinds of on-the-job training do you
provide for people in new or changed
jobs? Does this include contract and
agency personnel?
Review the records, if any.
Record of training are available. Contract
and agency are not used in this factory.
How do you inform personnel about the
consequences to the customer of
nonconformity to quality requirements?
(Sample throughout organization)
Select a few workers at the manufacturing area, By meeting, and posting of process files on
and ask them to show the defect part and
site as work instruction and red sign on
explain the consequence of this defective part. specify product/process characteristic. SEE
PHOTOS # 29 & #30.
What process has been established to
motivate employees to
- achieve quality objectives
- to make continual improvements, and
- to create an environment to promote
innovation
a) Any promotion activities?
b) Employee satisfaction survey and record?
c) Are KPIs published at each workplace for
employee to review?
1. Salary increase of 10% to 15%
2. KPIs are published on site.
3. Employee satisfactory survey
(Q/YCQP 4021-05) conducted in 20XX-1120, and summarized in Q/YCQP4021-06.
Does the process include the promotion
of quality and technological awareness
throughout the whole organization?
a) Is the promotion documented and
communicated ?
b) Any evidence records for quality /
technological?
Yes, a promotion is planned to enforce
quality and technological awareness
throughout the whole organization. SEE
PHOTO #31.
What records do you have that
personnel performing specific assigned
tasks are qualified - especially to meet
customer requirements? (See 6.2.2e)
6.3q1b
6.3q1c
a) Is there any questionnaire test for employee Yes, there is questionnaire test applied as
to evaluate their knowledge?
part of test exam. SEE PHOTO #26.
Are the buildings, workspace and utilities
provided appropriate to achieve
conformity to product requirements?
How are they maintained?
a) Visit the facility, specially the condition of how Yes. SEE PHOTO #5, #6 & #17.
product / material are stored.
b) Verify if the factory has a maintenance
program.
What kind of process equipment (both
hardware and software) is necessary to
conform to product requirements? How
is the equipment maintained?
Listed in the factory profile, take photos.
What supporting services (such as
transport or communication) are needed
to ensure that product meets
requirements? How are they
maintained?
Listed in the factory profile and take photos.
What groups are involved in developing
plant, facility and equipment plans?
(Must be multidisciplinary)
Verify if there is map route describing position
of machine, storage of material, moving of
people.
C
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C
C
Infrastructure
6.3.1
T6.3.1q1
I
C
What process has been established to
measure the extent to which personnel
are aware of the relevance and
importance of their activities and how
they contribute to the achievement of the
quality objectives?
(See 6.2.2d)
6.3
6.3q1a
SCORE
Yes, for client, only need an assembly line.
SEE PHOTOS #32, #33 & #34. The factory
also has a stamping workshop. SEE
PHOTOS #5 & #6.
C
C
Yes, the factory use automatic conveyor at
the painting process.
C
Plant, Facility and Equipment Planning
The maintenance department is in charge
of this. There is visible map route and
layout at each workshop. SEE PHOTO #35.
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
T6.3.1q2
T6.3.1q3
Yes, the plant layouts optimize material
travel, handling and floor space use, and
facilitate synchronous material flow. SEE
PHOTOS #5 & #6.
What methods are used to evaluate and
monitor the effectiveness of existing
operations?
Record of periodical evaluation of time used to
move material from this location to another
place, a long a certain pathway.
With periodical evaluation of each process.
Can you show contingency plans for
each of the following?
- Utility interruptions
- Labor shortages
- Key equipment failure(s)
- Field returns
a) Verify if there is a documented plan to handle Yes, there is contingency plan for labor
sudden short down in the planning, take photo shortage, key equipments failure…etc.
of the plan.
b) Ask
if such situation happen, and what was the
impact.
c)
Does the contingency plan describe
responsibility?
Has the organization defined the
adequate work environment required to
achieve conformity to product
requirements? How is this environment
managed and maintained?
a) Verify is adequate temperature / humidity,
noise, odors, cleanliness, lighting, etc. are
defined as basic condition for work
environment.
b) Verify if those conditions are checked and
recorded.
T6.4.1q1
T6.4.2q1
How are product safety and potential
risks to employees addressed by the
organization?
7.1q3a
7.1q3b
C
C
Yes, as required in the procedure.
(Q/YCQP2018-2011)
C
Each machine has user manual visible.
Could better be written with images that
indicate what to do when using it, both at
workshop and testing center.
Does the organization maintain the state
of order, cleanliness and repair needed
for products and manufacturing
processes? (Verify throughout audit)
I
Yes, it is clean and well organized at the
stamping plant and assembly plant.
C
PRODUCT REALIZATION
7.1
7.1q2
C
Work Environment
7
7.1q1
SCORE
Contingency Plans
6.4
6.4q1
FINDINGS
a) Is the pathways visible defined for material
storage, machines position and peoples
rotation? Take photo.
b) Is the direction of moving clearly marked?
6.3.2
T6.3.2q1
EVIDENCE TO CHECK
Can you show that plant layouts
optimize material travel, handling and
floor space use, and facilitate
synchronous material flow?
Planning of Product Realization
Are the processes needed for product
realization identified?
Verify if there a process map or flow chart for
product realization and note doc nb / rev.
Yes, the guidelines are described in the
procedure (Q/YCQP2004-2011), under
responsibility of production department.
Is the planning of product realization
Check the relation between this process with
consistent with the requirements of the others process. Define where it gets input and
other processes of the QMS? Verify
where its output goes.
there are no inconsistencies or conflicts
between quality system procedures.
Defined with previous process as marketing
dev, order review, product development,
and with next process as continuous
improvement.
Where in the product realization process a) Verify if the step for the identification of product
do you determine the quality objectives requirements are planned.
and requirements for products?
b) Check if there a record as example of any
product.
Yes, it planned, as for example of the
development of product / project #198911E. SEE PHOTO #36. The identification is
planned with the output recorded in the
form (Q/YCQP-4003-32-2012).
When planning for product realization,
how do you establish processes,
documents, and provide resources
specific to the product?
The planning of production realization is
documented as project planning such as for
the case of project #198911-E. SEE
PHOTO #36.
a) Verify if there is planning.
product.
C
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Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
7.1q3c
7.1q3d
7.1q4
EVIDENCE TO CHECK
How do you determine verification,
validation, monitoring, inspection and
test activities specific to the product, and
the criteria for product acceptance?
FINDINGS
The stage of verification, validation and
monitoring of production realization are
documented as project planning such as for
the case of project #198911-E. SEE
PHOTO #36.
What records exist showing that both the Check if there a record as example of any
realization processes and the product
product.
meet requirements?
Records of the four stages are available,
example of the project #198911-E.
What are the outputs of product
Verify if there a documented planning.
realization planning? Are they in a form
suitable for the organization?
Yes, forms are used to record output of the
product realization.
7.1.1
T7.1.1q1
a) Verify if there is planning defining method for
verification, validation…etc.
product.
Yes, it included, example of the project
#198911-E
7.1.2
Acceptance Criteria
Where are acceptance criteria defined? Check a record of such acceptance criteria, and Acceptance criteria are defined for each
When required, does the customer
check if there is an evidence that it was approved stage as guideline to accept the completion
approve them?
by the customer.
of each stage
When attribute data sampling, is the
acceptance level zero defects?
Check the inspection criteria.
7.1.3
T7.1.3q1
T7.1.4q3
T7.1.4q5
7.2.1q1c
Yes, the acceptance level zero defects is
applied.
C
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Change Control
What process is there to control and
react to changes that impact product
realization?
Changes that happen during process
development are monitored according to
guidelines detailed in the procedure.
(Q/YCQP-2003-2011)
Are changes validated before
implementation?
Yes, changes re-validated by a group of
team members before to process.
Do you have evidence that any
additional verification/identification
requirements required by the customer
are met?
Yes, records are available.
C
C
C
Customer-Related Processes
7.2.1
7.2.1q1b
C
By customer property (Q/YCQP2005-2011).
7.2
7.2.1q1a
C
Confidentiality
How does the organization ensure the
confidentiality of customer-contracted
products, projects under development,
and related product information?
7.1.4
T7.1.4q1
C
Planning of Product Realization – Supplemental
Does the quality plan include customer Review the quality plan
requirements and reference to technical
specifications?
T7.1.2q1
T7.1.2q2
SCORE
Determination of Requirements Related to the Product
Does the organization determine
requirements specified by the customer,
including the requirements for delivery
and post-delivery activities?
Yes, the organization determines
requirements specified by the customer,
including for delivery and PPM, as required
by the procedure (Q/YCQP3001-2008) and
document them in (Q/YQCP-4003-322012). SEE PHOTO #14.
Does the organization determine not
stated by the customer but necessary for
specified or intended use, where known?
Yes, it included in the document (Q/YQCP4003-32-2012). SEE PHOTO #14.
Does the organization determine
statutory and regulatory requirements
related to the product?
Yes, it is included in the document
(Q/YQCP-4003-32-2012). SEE PHOTO
#14.
C
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Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
7.2.1q1d
T7.2.1.1q1
7.2.2q1b
7.2.2q4
T7.2.2.2q1
Does the organization meet customer
requirements for designation,
documentation and control of special
characteristics?
Yes, all requirements are meet according to
the PSW signed by CVGS.
A feasibility review is conducted involving all
departments, and each department will
review product requirements and sign to
conform that they have the capability to
meet client requirements.
How do you ensure that product
requirements are defined and reviewed
before committing to supply product?
The procedure Q/YCQOP-2003-2011 is
been developed to required a mandatory
step to conduct the feasibility before
launching the project.
When product requirements are
changed, how do you ensure that
relevant documents are changed and
that relevant personnel are made aware
of the changes?
What documents do you have that show
investigation and confirmation of
manufacturing feasibility in the contract
review process for proposed products,
including risk analysis?
According to change procedure. There are
a few examples of how changes were
implemented.
7.3.1q2b
7.3.1q2c
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C
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Customer Communication
Procedure (Q/YCQP2021-2011), via
customer representative.
Do your customers require information to
be communicated in specific languages
and/or formats?
If so, how do you meet those
requirements?
Yes, specific format to use, and in English
must of the time. The factory has people
with English capability, such as Ms. XXX,
the Customer Rep.
C
C
Design and Development
7.3.1
7.3.1q2a
C
Yes, there are few case where feasibility
were conducted.
What method(s) are used to
communicate with customers regarding
- product information
- enquiries, contracts, or order handling
including amendments?
- feedback, including customer
complaints
7.3
7.3.1q1
SCORE
Review of Requirements Related to the Product
What kind of review is done to ensure
that the organization has the ability to
meet requirements before committing to
supply product?
7.2.3
7.2.3q1
FINDINGS
Yes, it is included in the document
(Q/YQCP-4003-32-2012). SEE PHOTO
#14.
7.2.2
7.2.2q1a
EVIDENCE TO CHECK
Does the organization determine any
additional requirements determined by
the organization.
Design and Development Planning
Can you explain to me the process used
by the organization to plan and control
the design and development of product?
There is a procedure Q/YCQP-2003-2011
for development of process according to
APQP / PPAP.
C
What are the stages in the design and
development process?
There are four stages for the development,
for example of the project CVGS (OEM), for
part 198911-E, the plan is documented in
Q/YCQP4003-04.
C
Are the review, verification and validation
activities appropriate to each design and
development stage planned?
Yes, there are review, verification and
validation at each stage. Example of part
198911-E, the plan is documented in
Q/YCQP4003-04.
Are design and development
responsibilities and authorities defined?
Yes, responsibility is well defined. Example
of part 198911-E, the plan is documented in
Q/YCQP4003-04.
C
C
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7.3.1q3
T7.3.1.1q1
How does the organization ensure
effective communication and clear
assignment of responsibility between
different groups involved in design and
development?
Do you use a multidisciplinary approach
to prepare for product realization? Does
it include:
- development/finalization and
monitoring of special characteristics
- development and review of FMEAs,
including actions to reduce potential
risks,
- development and review of control
plans.
7.3.2
7.3.2q1a
7.3.2q2
EVIDENCE TO CHECK
FINDINGS
Yes, responsibilities are well defined.
Example of part 198911-E, the plan is
documented in Q/YCQP4003-04.
SCORE
C
NOTE A multidisciplinary approach typically
Yes, there is multidisciplinary approach,
includes the organization's design, manufacturing, with mission to develop and finalize special
engineering, quality, production and other
characteristic, record are available
appropriate personnel.
C
Design and Development Inputs
What are the design inputs relating to
each of the following product
requirements?
a) functional and performance
requirements
b) applicable statutory and regulatory
requirements
c) where applicable, information derived
from previous similar designs, and
d) other requirements essential for
design and development.
Where are they recorded?
How & when are the design inputs
reviewed for adequacy?
The factory does not have design
responsibility.
N/A
responsibility.
N/A
7.3.2q3
How does the organization ensure that
requirements are complete,
unambiguous and don’t conflict with
each other?
7.3.2.1
T7.3.2.1q1
NOTE: Special characteristics (see 7.2.1.1) are
included in this requirement.
responsibility.
N/A
Product Design Input
Where are product design input
requirements documented?
(including the following:
- contract reviews of requirements such
as special characteristics, identification,
traceability and packaging
- a process to deploy information gained
from previous design projects,
competitor analysis, supplier feedback,
internal input, field data, and other
relevant sources, for current and future
projects of a similar nature
- targets for product quality, life,
reliability, durability, maintainability,
timing and cost.)
Can you show me they are reviewed?
7.3.2.3
responsibility.
N/A
Special Characteristics
T7.3.2.3q1a Can you show me that all special
characteristics are identified and
included in drawings, FMEAs, control
plans, and operator instructions?
Special characteristics are defined in the
form (Q/YCQP4003-08).
T7.3.2.3q1b Are the customer-specified (or
equivalent) symbols used?
Yes, customer-specified symbols are used
in PFD, PFMEA, CONTROL PLAN and
work instruction. SEE PHOTOS #29 & #30.
C
Yes, customer-specified symbols are used
in PFD, PFMEA, CONTROL PLAN and
work instruction. SEE PHOTOS #29 & #30.
C
T7.3.2.3q1d Do they include process steps that affect
special characteristics?
C
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7.3.3
7.3.3q1
T7.3.3.1q1
EVIDENCE TO CHECK
FINDINGS
Design and Development Outputs
How can design and development
outputs be verified against the inputs?
(see 7.3.5q1) Are these outputs
approved prior to release?
Outputs of development are verified by
dimensional checking, and compared to
requirements. Records are maintained.
Can you show that the product design
outputs include
Not applicable.
- design FMEA, reliability results
- product special characteristics, specifications
- product error-proofing, as appropriate
- product definition including drawings or
mathematically based data
- product design reviews results, and
- diagnostic guidelines where applicable
Are the outputs expressed in terms that can be
verified and validated against product design input
requirements?
T7.3.3.1q1
Can you show that the manufacturing
process design outputs include
- specifications and drawings,
- manufacturing process flow chart/ layout,
- manufacturing process FMEAs,
- control plans,
- work instructions,
- process approval acceptance criteria,
- data for quality, reliability, maintainability and
measurability
- results of error-proofing activities, as appropriate,
and
- methods of rapid detection and feedback of
product/manufacturing process nonconformities.
7.3.4
7.3.4q1a
SCORE
C
N/A
The manufacturing process design output shall be
expressed in terms that can be verified against
manufacturing process design input requirements
and validated.
Yes, the outputs include all the data, full
dimension report (Q/YCQP-4003-13), PFD,
PFMEA, Control plan (Q/YCQP-4003-30),
Ppk (Q/YCQP-4003-18), etc.
C
Design and Development Review
At what stages of design and
development do you perform reviews to
evaluate if the results meet
requirements? (See 7.3.1q2b)
The review is performed to evaluate the
progress of the APQP planning. It can be
done at each stage.
C
Can you show me some problems that
have been identified and actions
proposed at these reviews?
7.3.4q2
7.3.4q3
What functions are represented at these
reviews?
At each stage, are all functions
concerned with that stage represented?
All function are represented.
Can you show me records of the results
of the reviews and any necessary
actions taken?
SEE PHOTO #39.
7.3.5
7.3.5q1
7.3.5q2
7.3.6q3
C
Design and Development Verification
What verification activities are performed
to ensure that the design and
development outputs have met the input
requirements? (See 7.3.3q1)
Verification is performed by checking size,
functionality and visual appearance and
comparing it to requirements in the drawing.
of the verification activities and resulting
actions?
SEE PHOTO #40.
7.3.6
7.3.6q1
C
C
C
Design and Development Validation
What design and development validation
activities are performed to ensure that
the product is capable of meeting the
requirements for the intended use?
The validation is done by the client, after
sending the PPAP document and sample to
them. The client will send a PSW as sign of
approval.
Can you show me records of the
validation activity results and any followup actions?
SEE PHOTO #41.
C
C
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7.3.7
7.3.7q1
7.3.7q2
EVIDENCE TO CHECK
Is design and development validation
performed in accordance with customer
requirements, including program timing?
Control of Design and Development Changes
How are design and development
changes identified? Where are the
records kept?
Changes could be identified from internal or
from customer, and will be handled
according to the procedure (Y/QCDP20102011)
Are changes reviewed, verified,
validated, and approved before
implementation?
Yes, changes are reviewed, verified,
validated, and approved before
implementation. Records are available.
C
How do you ensure that purchased
product conforms to specified purchase
requirements?
The factory has a procedure as guideline
for ensuring the conformity of product
(Q/YCQP2019-2011).
C
How do you determine the type and
extent of control applied to the supplier
and the purchased product?
The factory has a master list of qualified
supplier recorded in the form Q/YCQP-401903. SEE PHOTO #42.
How do you evaluate and select
suppliers based on their ability to supply
product in accordance with the
organization’s requirements?
The factory will conduct investigation of the
supplier and record it in the Q/YCQP-401905.
Can you show me the criteria for
selection, evaluation and re-evaluation
of suppliers?
of supplier evaluations and any
necessary actions? Verify that criteria
have been met.
Yes, recorded in the form Q/YCQP-401906, conducted in 20XX-01-20 as yearly
evaluation approved by General Manager,
with hand signed by himself. SEE PHOTO
#43.
What evidence is there that all
purchased products or materials used in
product conform to regulatory
requirements?
The factory conduct monthly evaluation of
each supplier about QUALITY (40),
DELIVERY(20), SERVICE(20) and
PRICE(10), and data is recorded
automatically in the ERP system in the form
Q/YCQP-4019-07.
7.4
PURCHASING
Purchasing Process
7.4.1q2
7.4.1q3
7.4.1q4
7.4.1q5
T7.4.1.1q1
T7.4.1.2q1a What supplier development actions are
being taken toward the goal of supplier
conformity with TS 16949?
T7.4.1.2q1b Do your suppliers’ quality management
systems conform with ISO 9001:2000?
T7.4.1.2q2
SCORE
C
7.4.1
7.4.1q1
FINDINGS
Yes, the customer will conduct the
validation .
Are all of your suppliers registered to
ISO 9001:2000?
If not, do you have written waivers from
applicable customer(s)?
C
C
C
C
Yes, two suppliers have provided
commitment to achieve the goal of TS
certification by the end of the year 20XX.
One out of twenty-one has passed the TS,
SEE PHOTO #44.
NOTE: The prioritization of suppliers for
Yes, 13 suppliers are certified to ISO 9001,
development depends upon, for example, the
and those suppliers are more important.
supplier’s quality performance and the importance
of the product supplied.
C
C
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C
Yes, 13 suppliers are certified to ISO 9001,
and those suppliers are more important.
C
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T7.4.1.3q1
7.4.2
7.4.2q1a
7.4.2q1b
7.4.2q1c
7.4.2q2
T7.4.3.1q1
T7.4.3.2q1
7.5.1q1c
C
Yes, reviewed the order number
2014030757 and all information are
included.
Do require any qualification of supplier
personnel? If so, can you show where
the requirement is documented?
Yes, completed.
Do you have any QMS requirements of
your suppliers? If so, can you show me
where they are required?
Yes, documented.
How does the organization ensure the
adequacy of purchasing requirements
before communicating them to the
supplier?
Communication is done by email, or
physically with sign from supplier in the
purchase order.
C
Incoming inspections are conducted
following criteria defined in file (Q/YCQP 3023-03-2012), SEE PHOTO #45.
C
Must include one or more of following:
- evaluation of supplier statistical data
- receiving inspection and/or testing
- second- or third-party audits of suppliers, along
with records of acceptable quality
- laboratory part evaluation
- another method agreed with the customer
Incoming inspections are conducted
following criteria defined in file (Q/YCQP 3023-03-2012). SEE PHOTO #45. And
records are maintained in form (Q/YCQP 4023-03-2012). SEE PHOTO #46.
C
Must include the following indicators:
- delivered product quality
- customer disruptions including field returns
- delivery schedule performance (including
incidents of premium freight)
- special status customer notifications related to
quality or delivery issues
The factory conducts monthly evaluation of
each supplier about QUALITY (40),
DELIVERY(20), SERVICE(20) and
PRICE(10). Data is recorded automatically
in the ERP system in the form (Q/YCQP4019-07). SEE PHOTO #47.
C
C
C
Verification of Purchased Product
What inspection or other activities are
used to ensure that purchased product
meets your purchasing requirements?
What processes are in place to assure
the quality of purchased product?
How do you monitor supplier
performance?
C
Production and Service Provision
7.5.1
7.5.1q1b
SCORE
Purchasing Information
7.5
7.5.1q1a
FINDINGS
Yes, all information is included in the plan.
The factory has a written program to
monitor suppliers.
Do orders/contracts include
requirements for approval of product,
procedures, processes and equipment?
7.4.3
7.4.3q1
EVIDENCE TO CHECK
Do your customer(s) specify supplier(s)
in contracts/ purchase orders?
This includes products, materials,
services, tooling, & gages, etc.
If so, can you show that the customerdesignated sources are being used as
required?
Control of Production and Service Provision
When carrying out production (or
service) is information that describes the
characteristics of the product available?
Yes, information that describes the
characteristics of the product available in
work Instruction, for example of part
752116400.
service) are appropriate work
instructions available if needed? (See
7.5.1.2)
Yes. SEE PHOTO #29.
service) is suitable equipment used for
carrying out production (or service)?
Yes, equipment is available.
C
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7.5.1q1d
7.5.1q1e
T7.5.1.1q2
T7.5.1.1q3
T7.5.1.1q4
service) are appropriate kinds of
monitoring and measurement done?
(See 8.2.4)
Yes, necessary monitoring is conducted,
according to in-process inspection.
T7.5.1.2q2
T7.5.1.3q2
C
Review control plans to ensure they:
- list controls used for manufacturing process
control
- include methods for monitoring of control of
special characteristics
- include customer-required information, if any
Yes, there is control plan developed for
each product in which a PPAP is been
required. SEE PHOTO #48.
C
Yes, there is a control plan developed for
each product in which a PPAP has been
Can you show how the control plans
take into consideration design FMEA
and process FMEA information?
(See Annex A)
Yes, there is control plan developed for
each product in which a PPAP is been
Can you show that specified reaction
plans have been carried out when a
process becomes unstable or not
statistically capable?
SEE PHOTO #48.
C
C
C
Work Instructions
Do all employees responsible for
Verify throughout audit.
processes that impact product quality
have documented work instructions? Are
they accessible for use at the
workstation?
How are the work instructions
developed?
Yes. SEE PHOTOS #29 & #30.
C
SEE PHOTOS #29 & 30.
C
Verification of Job Setups
Can you show me records of job setups
that are being performed?
Do they occur at the initial run of a job,
material changeover, or job change?
Yes, records are written. See photo of U771066-MJ-01.
What work instructions do you have for
job setup personnel?
Yes. SEE PHOTOS #29 & #30.
7.5.1.4
T7.5.1.4q1
C
Can you show me control plans for both
pre-launch and production?
7.5.1.3
T7.5.1.3q1
SCORE
Control Plan
Can you show me control plans for
system, subsystem, and component/
material levels for product supplied?
7.5.1.2
T7.5.1.2q1
FINDINGS
Yes, gages are available.
7.5.1.1
T7.5.1.1q1
EVIDENCE TO CHECK
service) are appropriate gages, etc.
used in production (or service)? (See
7.6)
C
C
Preventive and Predictive Maintenance
How do you identify key process
equipment? Can you walk me through
your total preventive maintenance
system?
Verify that the TPM system includes the following:
- planned maintenance activities
- packaging and preservation of equipment,
tooling and gauging
- availability of replacement parts for key
manufacturing equipment
- documenting, evaluating and improving
maintenance objectives
There is a procedure Q/YCQP-2006-2011,
B/0 that defined key process equipment in
section 3.1 and provided guideline for their
maintenance and reparation.
C
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T7.5.1.4q2
7.5.1.5
T7.5.1.5q1
T7.5.1.5q2
T7.5.1.5q3
T7.5.1.5q4
T7.5.1.5q5
T7.5.1.5q6
EVIDENCE TO CHECK
What predictive maintenance methods
do you use? Can you demonstrate that
predictive maintenance has resulted in
continual improvement of the
effectiveness and efficiency of
production equipment?
FINDINGS
Accident occurrence are recorded in the
form Q/YCQP4006-08 and their root cause
is investigated in the form Q/YCQP-4006-06
(B/0). See example of machine #YC29.
Data collected are not properly used to
develop an efficient predictive action.
SCORE
I
Management of Production Tooling
What resources have the organization
provided for tool and gage design,
fabrication and verification activities?
The factory has capability for tooling design
and production, but will also assigned the
design and production responsibility to an
external supplier.
Does the production tooling
management include maintenance and
repair facilities and personnel?
There is procedure for Q/YCQP-2007-2011
for the maintenance of mold, fixtures,
tooling. Specified in the section 3.1
C
Do you have space for storage, recovery
and set-up of tooling?
Yes, the factory has special place for the
storage of tooling.
C
Do you have perishable tool change
programs?
There is accumulation time of use in the
record CV of each tooling, for example
345844-SHEET2-M1-01, with indication of
some per production and its accumulate,
but not standard number of time. No
reaction of what do to after reach the time.
Does tool design modification
documentation, including engineering
change level, tool modification and
revision to documentation monitored?
Yes, controlled by technical department.
Tool identification, defining the status,
such as production, repair or disposal.
Tool are well identified and protected. SEE
PHOTOS #17 & #49.
C
I
C
C
T7.5.1.5q3
Are any tooling management activities
outsourced? If so, how are these
activities monitored?
7.5.1.6
T7.5.1.6q1
Yes, some tolling is outsourced.
C
Production Scheduling
Can you demonstrate that customer
scheduling requirements (such as just-intime) are being met?
7.5.3
Yes, the factory uses public board to display
the status of each order, with principle of
JIT.
C
Identification and Traceability
How do you identify product throughout
your processes? Verify in production,
storage, segregation areas, etc.
Products are identified as required in the
procedure (Q/YCQP2008-2011).
How is product inspection status
identified? Verify in production, storage,
segregation areas, etc.
Each product has label to indicate its detail
and status. SEE PHOTO #50.
Can you show me unique identification
records for products requiring
traceability?
SEE PHOTO #50.
C
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7.5.4
7.5.4q1
7.5.4q2
T7.5.4.1q1
T7.5.5.1q2
7.6q2
7.6q3a
7.6q3c
7.6q3e
7.6q4
7.6q5
7.6q6
SCORE
Customer Property
Yes, the factory use customer drawing,
tooling as customer property.
How do you ensure that customerowned property is identified, verified,
protected, and safeguarded?
Customer property is controlled as defined
in the procedure (Q/YCQP2005-2011).
How are customer-owned tools and
equipment identified?
Customer-owned tools and equipment
identified are identified with customer name
and part number.
N/A
C
C
Preservation of Product, Storage and inventory
Can you walk me through your inventory
management system?
How does the system optimize inventory
turns over time and assure stock
rotation?
How is obsolete product controlled to
prevent its unintended use or delivery?
(See 8.3).
7.6
7.6q1
FINDINGS
Do you use any customer-owned
property, such as product, packaging,
drawings, tooling, gages, etc
If so, ask questions below.
7.5.5
T7.5.5.1q1
EVIDENCE TO CHECK
Inventory is conducted via ERP system that
can provide in real-time the status of stock,
and send information to purchase
department.
C
Obsolete product is stored in "red" room to
avoid them to be mixed with others.
C
Control of Monitoring and Measuring Devices
How do you determine the
measurements to be taken and the
measuring equipment needed to
demonstrate conformity with
requirements?
What process is in place to ensure that
measurements are taken per the
requirements?
Measuring devices are controlled according
to procedure (Q/YQCP2020-2011).
C
A calibration program is in place to ensure
it. The factory is experiencing an Excel
support tools to alert in the approach of
expiration date, but formulas in this system
are wrongly defined.
I
How do you ensure that measuring and
test equipment is calibrated or verified
proper frequencies with NIST traceable
standards? If no such standards exist,
where do you record the basis used for
calibration or verification?
External calibration is conducted as
planned, and are traceable to external
national institute.
How are measuring tools identified to
enable the calibration status to be
determined?
With tags visible at each device.
How do you ensure that measuring its
test equipment is protected from
damage and deterioration during
handling, maintenance and storage?
Equipment is well protected in the testing
center under acceptable room condition.
SEE PHOTOS #18, #19, #20, #21, #22 &
#23.
When equipment is found to be out of
calibration, how do you assess and
record the validity of the previous
measuring results?
There is no specific plan as reaction plan in
the case of out of calibration found, and
others damage.
NC
What actions do you take on the
equipment and any product affected?
There is no specific plan as reaction plan in
the case of out of calibration found, and
others damage.
I
Can I see your records of the results of
calibration and verification?
Yes, record of in-house are available by
computerized. No signature of the person
assigned for the in-house calibration.
I
C
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7.6q7
T7.6.1q1
T7.6.1q2
FINDINGS
SCORE
Do you use computer software for
monitoring and measurement? If so, is
its ability to perform that function
confirmed prior to initial use and
reconfirmed as necessary?
External calibration is conducted as
planned, and are traceable to external
national institute, while calibration in house
does not provide evidence of such
traceability to that external national institute.
I
Can you show me R&R studies for each Is there other statistical studies analyzing the
type of measuring and test equipment
variation in measurement & test results?
system referenced in the control plan?
GR&R is conducted for related equipment
used to conduct product to which PPAP
were required.
C
Do the methods and acceptance criteria
conform to those in customer reference
manuals on MSA or does the customer
approve them?
Yes, the AIAG format is no longer used.
7.6.2
T7.6.2q3
T7.6.2q6
EVIDENCE TO CHECK
C
Calibration / Verification Records.
Can you show that calibration records
include equipment identification,
including the measurement standard
against which the equipment is
calibrated.
Calibration record are available both for
external. SEE PHOTO #51. Record for inhouse calibration is also available, but with
no proper traceability of standard used.
Statements of conformity to specification
after calibration / verification.
SEE PHOTO #51.
I
C
T7.6.2q7
Notification to the customer if suspect
product or material has been shipped?
Not planned, but has never happened.
I
7.6.3
T7.6.3.1q1
T7.6.3.1q2
T7.6.3.2q1
T7.6.3.2q2
Laboratory Requirements
Does the organization have an internal
laboratory?
If so, can you show a documented
laboratory scope including its capability
to perform inspection, test, or calibration
services?
Where
are laboratory technical
requirements specified for
- adequacy of laboratory procedures
- competency of the laboratory
personnel
- testing of the product,
- capability to perform these services
correctly, traceable to the relevant
process standard, and
- review of the related records
Have these requirements been
implemented?
Can you show me laboratory scope(s)
for external/commercial/independent
laboratory facilities that include the
capability to perform the required
inspection, test or calibration?
Can I see evidence that each laboratory
is either accredited, or is acceptable to
the customer(s)?
The factory has testing center, not a
laboratory, SEE PHOTO 19, 20, 21, 22, 23.
C
Adequacy of listable procedure with
images, and competency of lab people is
not visible. Not visible is also the capability
to perform services correctly and traceable
to respective standard.
I
The lab is for internal use, not external or
commercial. There is no scope.
N/A
The lab is for internal use, not external or
commercial. There is no scope.
N/A
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8
T8.1.1q1
General
Have appropriate statistical tools for
each process been determined and
included in the control plan? (See
7.5.1.1)
T8.2.1.1q1
8.2.2q2
8.2.2q3
8.2.2q4
Appropriate statistical tools for each
process has been determined in the
procedure (Q/YCQP2024-2011).
C
Monitoring and Measurement
Customer Satisfaction
How do you obtain information about
customer perception as to whether the
organization has met customer
requirements? How is this information
used?
The organization defined a plan to obtain
customer feedback in the (Q/YCQP20242011) through customer satisfaction survey.
The information is used as input to
management review meeting.
What realization process performance
Do they include at least:
indicators are used to monitor customer - delivered part quality performance
satisfaction?
- customer disruptions including field returns
- delivery schedule performance (including
incidents of premium freight), and
- customer notifications related to quality or
delivery issues
Client complaint log and customer
satisfaction surveys are used, including
internal OTD.
How do you monitor manufacturing
processes to demonstrate compliance
with customer requirements for product
quality and process efficiency?
The manufacturing is monitored with daily
rate evaluation and at some process with
SPC system.
8.2.2
8.2.2q1
C
Knowledge of Basic Statistical Concepts
8.2
T8.2.1.1q1
Yes, appropriate statistical tools for each
process has been determined in the
procedure (Q/YCQP2024-2011), where
SPC are used at process, and graphical
statistic of conformity rate applied to each
process and result displayed. SEE PHOTO
#15.
How does the organization ensure that
basic statistical concepts are understood
and utilized throughout the organization?
Verify throughout audit,
8.2.1
8.2.1q1
SCORE
Identification of statistical tools
8.1.1
T8.1.2q1
FINDINGS
MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1
8.1.1
EVIDENCE TO CHECK
C
C
C
Internal Audit
Are internal audits being conducted at
planned intervals? Do they determine
whether the QMS conforms to the
requirements of ISO 9001 and to the
other requirements established by the
organization? Do they determine
whether the QMS is effectively
implemented and maintained?
Reviewed records to demonstrate
conformance.
Can you show me an audit plan that
takes into consideration the importance
of the processes and areas to be
audited, and the results of previous
audits?
Where are the audit criteria, scope,
frequency and methods defined?
Yes, there is the audit plan described in
Q/YCQP-4022-01 (a/0), nb. 2013001, and
approved in 20XX-02-09.
Can you demonstrate that selection of
auditors and the conduct of audits are
objective and impartial, and that auditors
don’t audit their own work?
The factory has 12 auditors. And it requires
to avoid auditors to be organized
independently to their process.
C
Yes, the scope of the audit is described in
the Q/YCQP-4022-01 (a/0).
C
C
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
8.2.2q5
8.2.2q6
T8.2.2.1q1
EVIDENCE TO CHECK
FINDINGS
Can you show me your internal audit
procedure? Can you show me the
records of internal QMS audits?
Yes, records of internal audit are available,
see photo Q/YCQP-4022-08.
Who ensures that actions are taken to
eliminate detected nonconformities and
their causes? Are they being taken care
of in a timely manner? (verify with
records)
The MR is in charge to ensure that NCF are
solved, and recorded maintained, see photo
, Report nb. 2013-NA-001 for article
TS16949-7.3.6
Do you have audit records showing that
the entire QMS is being audited?
SCORE
C
C
C
T8.2.2.2q1
T8.2.2.3q1
T8.2.2.4q1
T8.2.2.4q2
T8.2.2.5q1
Do you have records showing that each
manufacturing process is being audited
to determine its effectiveness?
Yes, each process was audited.
Are there records showing that products
are being audited at appropriate stages
of production and delivery? Do the
audits verify conformity to all specified
requirements?
Yes.
Can you show me an annual audit plan?
Does it show that audits cover all QMS
processes, activities and shifts?
Yes.
Is there evidence that audit frequency is
increased due to nonconformances or
customer complaints?
No, not stated in the procedure.
How do you determine competence of
internal auditors to audit the
requirements of TS 16949? (See 6.2.2.2
– also customer specific requirements).
Certificate of audit is used as evidence.
8.2.3
8.2.3q1
8.2.3q2
8.2.3q3
T8.2.3.1q1
T8.2.3.1q2
C
C
C
I
C
Monitoring and Measurement of Processes
What methods are used to monitor and
measure the QMS processes?
Can you show that they have achieved
the desired results?
The internal audit is used as method to
monitor and measure the QMS processes,
as required in the procedure (Q/YCQP20222011). Apart from that, each process has
KPIs assigned with a monitoring plan and
responsible.
C
Some processes has KPIs displayed, with
acceptable result such as for Supplier
Monitoring, while customer satisfaction
survey shows some need in improvement.
C
When the desired results are not
achieved, what actions are taken to
ensure that the product meets
requirements?
The result was reviewed during a
management review meeting, and actions
are defined for improvement.
C
Can you show me process studies that
have been performed on new
manufacturing processes?
SEE PHOTO #52.
Can you show examples of results of
process studies being documented with
specifications? Are they used for
instructions?
SEE PHOTO #52.
N/A
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
T8.2.3.1q4
T8.2.3.1q5
8.2.4q2
8.2.4q3
FINDINGS
Yes, there are record that show that
process capability was evaluated and
approved by the client, thought PSW, see
the case of the client CVSG.
May I have a copy of the process flow
diagram and control plan for (mfg.
process) to review the production line
with? Review for adherence to specified
requirements.
The copy of PFD, and Control Plan are
available.
8.2.4
8.2.4q1
EVIDENCE TO CHECK
Do records show that manufacturing
process capability or original customerapproved performance is being
maintained?
SCORE
C
C
Monitoring and Measurement of Product
What characteristics are checked to
verify that product requirements have
been met?
Characteristics to check are clearly
documented at various, check plan, for IQC,
IPQC and FQC, as required in procedure
(Q/YCQP2023-2011).
At what stages of the product realization
process do monitoring and measuring
activities take place?
At incoming Inspection (IQC), In-process
inspection (IPQC) and final inspection
(FQC), mainly. SEE PHOTO #45.
How is evidence of conformity with
acceptance criteria maintained?
Record are available. SEE PHOTO #46.
C
C
C
8.2.4q4
8.2.4q5
T8.2.4.1q1
T8.2.4.2q1
Can you show me records that indicate
who has authorized release of product to
the next stage of the process?
Record are available, SEE PHOTO #46
How do you ensure that product is not
NOTE: When selecting product parameters to
released until the all requirements have monitor compliance to specified internal and
been met? If product must be released external requirements, the organization
prior to this, how is it approved?
determines the types of product characteristics,
leading to
- the types of measurement
- suitable measurement means, and
- the capability and skills required
At incoming inspection (IQC), in-process
inspection (IPQC) and final inspection
(FQC), mainly. Work Instruction for the
implementation of such operation are
available. SEE PHOTO #45.
Can you show me layout inspection and NOTE: Layout inspection is the complete
The layout inspection is documented. SEE
functional verification results?
measurement of all product dimensions shown on PHOTO #45.
Do they address applicable customer
the design records.
specifications and correlate with the
control plan requirements?
Are results available for customer
review?
Do you provide parts designated by
If so can you show that you have:
customer(s) as appearance items? If so, - appropriate resources including lighting for
what support to you have?
evaluation
- masters for color, grain, gloss, metallic brilliance,
texture, distinctness of image (DOI), as
appropriate
- maintenance and control of appearance masters
and evaluation equipment, and
- verification that personnel making appearance
evaluations are competent and qualified to do so
8.3
8.3q1
C
C
C
Yes, there are master for comparison, and
these master (standard) product are
approved by the client and put with proper
identification to avoid mixing with others
product.
C
Control of Nonconforming Product
How do you ensure that nonconforming
products are identified and controlled to
prevent unintended use or delivery?
(Verify product throughout audit)
The procedure Q/YCQP2024-2011 is been
developed as guideline to control nonconform product
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
8.3q2
8.3q3
8.3q4
8.3q5
8.3q6
When you have nonconforming product,
what methods do you use to deal with it?
a) by taking action to eliminate the detected
nonconformity
b) by authorizing its use, release or
acceptance under concession by a relevant
authority and, where applicable, by the
customer
c) by taking action to preclude its original
intended use or application.
Records are available, product is stored
with label at segregate area. SEE PHOTOS
#53 & #54.
When nonconforming product is
corrected, can you demonstrate that it is
re-verified to ensure it conforms to
requirements?
When nonconforming product is
detected after shipment, what actions
are taken, such as containment?
(Verify corrective action records)
Yes, actions are defined as to inform the
client.
C
C
Control of Reworked Product
Yes, there is special place for the
reworking, specially for welding reworking.
C
Customer Information
Do you have evidence that customers
are promptly notified if nonconforming
product is shipped?
No evidence saved.
I
Analysis of Data
What data is collected and analyzed to
demonstrate the suitability and
effectiveness of the QMS and to
evaluate where continual improvement
of its effectiveness can be made?
Internal / external PPM, OTD record,
supplier performance evaluation, NCF from
internal audit, amounts others KPIs
assigned, and customer satisfaction are
collected.
What information does this analysis
provide relating to:
- customer satisfaction (See 5.6)
- conformity to product requirements
(See 5.6)
- characteristics and trends of processes
and products (See 5.6)
- suppliers (See 7.4.1)
Internal / external PPM, OTD record,
supplier performance evaluation, NCF from
internal audit, amounts others KPIs
assigned, and customer satisfaction are
collected.
8.4.1
T8.4.1q1
C
C
Can you show me instructions for
rework? Do they include re-inspection
requirements? Are they accessible and
utilized?
8.4
8.4q1
SCORE
C
Can you show me records of
nonconforming product and any actions
taken? Are there any records of
concessions obtained?
8.3.3
T8.3.3q1
FINDINGS
The procedure Q/YCQP2024-2011 is
available and defines responsibilities.
8.3.2
T8.3.2q1
EVIDENCE TO CHECK
Can you show me your documented
procedure defining the controls for
dealing with nonconforming product?
Does it include related responsibilities
and authorities?
C
C
Analysis and Use of Data
How do you compare trends in quality
and operational performance with
progress toward objectives?
Does the comparison lead to action to
supporting the following?
- development of priorities for prompt
solutions to customer-related problems
- determination of key customer-related
trends and correlation for status review
decision-making and longer term
planning
- an information system for the timely
reporting of product information arising
from usage.
Data is used to compare trends in monthly /
annual basis and to display opportunities
from improvements. Decisions are taken
during management review meetings.
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
EVIDENCE TO CHECK
8.5
Improvement
8.5.1
Continual Improvement
8.5.1q1
T8.5.1.1q1
T8.5.1.2q1
Can you demonstrate that
Organization’s QMS effectiveness
continually improves?
What tools do you use?
(See 5.6, 8.2.2, 8.4, 8.5.2, 8.5.3)
Where has Organization defined a
process for continual improvement?
The internal audit is used a basic tool to
demonstrate that the organization's QMS
run effectively.
Can you show that CI efforts focus on
control and reduction of variation in
product and process characteristics after
capability, stability, and conformity?
Yes, there are records of continual
improvement. SEE PHOTO #31.
8.5.2
8.5.2q1
8.5.2q2
8.5.2q3
8.5.2q4
T8.5.2.1q1
T8.5.2.1q2
T8.5.2.2q1
FINDINGS
The process for continual improvement is
defined in the procedure (Q/YCQP20262011).
SCORE
C
C
C
Corrective Action
Do corrective actions records identify
and address root cause(s)? Do root
causes match actions?
Yes. Verified.
Are actions taken appropriate to the
severity of the problem?
Yes, for example of the case #130060 on
the part number 204327.
Can you show me a documented
procedure defining requirements?
C
a) Reviewing nonconformities (including customer Yes, the procedure (Q/YCQP2026-2011).
complaints)
b) Determining the causes of nonconformities
c) Evaluating the need for action to ensure that
nonconformities do not recur
d) Determining and implementing action needed
e) Records of the results of action taken
f) Reviewing corrective action taken
Can you show me records of corrective
actions taken?
Yes, and 8D report is used to identify root
cause of problem, for example of the case
#130060 on the part number 204327.
Where is the process for problem solving
defined?
Does it lead to root cause identification
and elimination? (Review records)
Yes, the procedure (Q/YCQP2026-2011)
If one or more customer requires a
specific problem-solving format can you
show me records documented as
required?
Yes, and 8D report is used to identify root
cause of problem. For example, the case
Can you show that error-proofing
methods are used in the corrective
action process?
Yes. SEE PHOTO #31.
8.5.2.4
C
C
C
C
C
C
Rejected Product Test/Analysis
T8.5.2.4q1a Can you show me records of analysis of
parts rejected by customer
manufacturing plants, engineering
facilities and dealerships?
Yes, an 8D report is used to identify root
cause of problem. For example, the case
C
T8.5.2.4q1b How long does the analysis take?
Are records made available (to
customers) upon request?
The lead time has been defined as couple
of weeks in the procedure (Q/YCQP20262011).
C
T8.5.2.4q1c Is the time consistent with the
determination of root cause, corrective
action and monitoring the effectiveness
of implementation?
Yes, the time is sufficient.
C
Rev.
AUDIT CHECKLIST
0
Supplier Name
XXXXXXXXXXXXXXX
Audit Date
Report No.
XX/XX/XXXX
XXXXXXXXX
QUESTIONNAIRES
8.5.3
8.5.3q1
8.5.3q2
8.5.3q3
EVIDENCE TO CHECK
FINDINGS
SCORE
Preventive Action
How do you determine potential
nonconformities to take action one?
Do preventive action records identify and
address root cause(s)?
PFMEA is used as mean tool to determine
potential nonconformities, and proposal
action are recorded.
C
Are actions taken appropriate to the
severity of the problem?
Yes, actions are taken in consideration of
the value RPN obtained from the Severity
(S), Occurrence (O) and Current Detection
Method (D).
C
Can you show me a documented
procedure defining requirements for
each of the following?
a) determining potential nonconformities
and their causes
b) evaluating the need for action to
prevent occurrence of nonconformities,
c) determining and implementing action
needed
d) records of results of action taken (see
4.2.4), and
e) reviewing preventive action taken
Yes, the procedure is Q/YCQP2026-2011.
C
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
1. Factory's main gate
2. Process map
3.Subsequence between processes
4. Organization
5. Stamping workshop
6. Stamping process & layout
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
7. Policy & Quality Objectives
8. Distribution of KPIs
9. Company policy posted at a public board
10. Master list of quality procedures
11. Master list of quality records
12. Evidence of identification of file under control
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
13. Nomination letter of management representative
14. List of identified customer special requirement
15. Status of KPIs published at workshop
16. Status of KPI as input for management Review
17. Storage of tooling
18. Meaurement device CMM
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
19. Salt spray test device
20. Function test
21. Project profile
22. Hardness test
23. UV machine
24. Training program
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
25. Training program for special job position
26. Traing test record
27. Training record
28 Document
29. Work instruction at assembly line
30. Work instruction at assembly line
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
31. Record of continual improvement.
32. A view of assembly line
33. A view of client's product
34. A view of packaging process for client's product
35. A view of layout at workshop
36. APQP file
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
37. List of special characteristic
39. Record of review at the 1st phase of APQP
40. Record of status of pahse 4th of APQP
41. PSW signed by the client for approve
42. List of qualified suppliers
43. Record of supplier evaluation
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
44. Suppliers certification program
45. Inspection criteria for IQC
46. Record of IPQC
47. Record of annual performance of supplier
48. Control plan
49. Indication of tooling status
Rev.
FACTORY PHOTOS
0
Supplier Name
Audit Date
Report No.
XXXXXXXXXXXXXXX
XX/XX/XXXX
XXXXXXXXX
50 A view of material handling and identification
51. A view of Inspection device & calibration certificate.
52. Record of client feedback about quality
53. Non-conforming storage and identification

Example Report: Pro QC

Transcription

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