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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
Pro QC Personnel
Mr./Mrs. XXXXXXXXXXXXXX Title: XXXXXXXXXX Email: XXXXXXXXXX
Mr./Mrs. XXXXXXXXXXXXXX Title: XXXXXXXXXX Email: XXXXXXXXXX
4. QUALITY
Category 8 MEASUREMENT, ANALYSIS
7. PRODUCT
AND 6.
IMPROVEMENT
RESOURCE
REALIZATION
5. MANAGEMENT
MANAGEMENTRESPONSIBILITY
MANAGEM
4. QUALITY MANAGEMENT SYSTEM ENT
Complies ( C ) 96.5% 91.67% 88.46% 91.89% 96.77%
Needed
5. MANAGEMENT RESPONSIBILITY 3.5% 7.58% 11.54% 8.11% 3.23%
Improvement ( I )
Not-complies
0.0% 0.76% 0.00% 0.00% 0.00%
(NC)
Not Applicable 6. RESOURCE MANAGEMENT
1.8% 12.12% 0.00% 0.00% 0.00%
(N/A)
7. PRODUCT REALIZATION
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
RECOMMENDATIONS
1 The system is well documented and implemented effectively. You could start or
continue business with this supplier.
2 The system is acceptable, with minor nonconformities noted. You could use this supplier
and keep pushing them for improvement.
3 System has several major issues noted. You could temporarily use this supplier and
request immediate corrective action in case of long-term business.
4 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.
ISO/TS 16949 QMS Audit Rev.
AUDIT REPORT 0
Supplier Name Audit Date Report No.
XXXXXXXXXXXXXXX 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.
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
4 QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
Has the organization established, Evidences of this question can be demonstrated Yes, the organization has established,
documented, implemented and throughout the audit. documented, implemented and maintains a
maintained a QMS and continually QMS according to ISO / TS requirements
4.1q1 improved its effectiveness in accordance (Exclude 7.3), and has evidences of C
with ISO/TS 16949:2009? continually improving its effectiveness.
Has the organization identified the Yes, the organization identified the
processes needed for the QMS and their processes needed for the QMS, in their
application throughout the organization? Quality Manual (Q/YCQP1001-2011, page
4.1q2a [ISO/TS 16949:2009, Art 4.2.2] 14/36), and their application throughout the C
organization. SEE PHOTO #2.
Has the organization defined criteria and Yes, the organization applies the approach
methods to uses to ensure that the of PDCA to monitor performance of
operation and control of QMS processes processes for effectiveness. Each process
4.1q2c are effective? has procedures and guidelines and with C
defined KPIs.
Has the organization provided resources Yes, resources are provided, with qualified
and information needed to support the operators under an organization chart and
operation and monitoring of QMS with adequate two facilities, with necessary
4.1q2d processes? (See Section 6) equipments. SEE PHOTOS #4, #5 & #6. C
Does the organization monitor, measure Yes, each process identified has specific
and analyze QMS processes? (See KPI, with responsibility for their monitoring,
Section 8) for improvement, as general KPI and as
KPIs distributed to each process and
department. It should the status of
4.1q2e C
satisfaction for the year 20XX, and planning
for the year 20XX. SEE PHOTOS #7 AND
#8.
Are processes needed for the QMS Yes, processes are managed with KPIs.
4.1q3 managed by the organization in SEE PHOTOS #7 and 8. C
accordance with the requirements of
ISO/TS 16949:2009?
When the organization outsources any The organization purchases few
process that affects product conformity components from others suppliers, and gets
with requirements, how is control support from external service for calibration
ensured over such processes? (See 7.4) of equipment. All of these external
4.1q4 outsources are managed according to the C
requirements of the Purchase Procedure
(Q/YCQP2019-2011).
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
Does the organization have adequate Yes, incoming inspections are conducted
control over outsourced processes to per random sampling. Suppliers are
T4.1.1q1 ensure conformity to all customer selected per requirement, and are C
requirements? evaluated on an annual basis.
(See 7.4)
4.2 Documentation Requirements
4.2.1q1a Does the organization have documented a) Review where it's written and note the doc, if Yes, the Quality Policy is documented in
statements of a quality policy (QP) and any. the Quality Manual (Q/YCQP1001-2011, rev
quality objectives (QO)? b) Check if the QP/QO posted in a visible place C), published and signed by GM. SEE
ISO/TS 16949:2009, Art 5.3, 5.4.1 for all employee to view. PHOTO #9. Quality objectives are also
c) Take a photo. listed, with a distribution to each C
department. SEE PHOTO #7.
4.2.1q1b Does Organization have a quality Review the Quality Manual, and note the doc. Yes, the factory has a Quality Manual 20XX
manual? ISO/TS 16949:2009, Art and rev. (Q/YCQP1001-2011, rev C) published in 20-
4.2.1(b) 09-30. C
4.2.1q1c Does the organization have the a) Review the procedure master list and confirm Yes, the factory has about 26 procedures as
documented procedures required by ISO that all mandatory procedures are included. guidelines for the implementation of QMS
9001:2008? b) Take a photo of the master list. according to TS requirements, listed in QM,
C
ISO/TS 16949:2009, Art 4.2.1(c) page 35/36. SEE PHOTO #10.
4.2.1q1d Are adequate documents in place to Evidences of this question could be Yes, documentation is visible at each place
ensure the effective planning, operation demonstrated throughout the audit. as guideline.
and control of t organization’s C
processes?
ISO/TS 16949:2009, Art 4.2.1(d)
4.2.1q1e Does documentation include the records a) Review the master list for record and confirm Yes, the factory has procedure for the
required by ISO 9001:2008? that all records monitored are included. control of record (Q/YCQP2013-2011, Rev.
ISO/TS 16949:2009, Art 4.2.1(e) b) Take photo of the master list. B/0.) There is a master list of ten pages
describing all Quality Record to save, C
including saving place, and time. SEE
PHOTO #11.
4.2.2q1b Does the quality manual (QM) contain or Check if doc numbers of procedures are written Yes, the QM contains references of
reference the documented procedures at relevant section of the QM to indicate procedures/documents to use. The name of
established for the QMS? appropriate procedure applied. the procedures are written as link. C
ISO/TS 16949:2009, Art 4.2.2(b)
4.2.2q1c Does the quality manual include a a) Check if there a document in annex of QM or Yes, there is process map described in the
description of the interaction between out of the QM, as document describing QM page 14/36, with five Customer related
the processes of the QMS? interaction between processes. processes (C1, C2, C3, C4), supporting
ISO/TS 16949:2009, Art 4.2.2(c) b) Take photo of the map. processes, and management processes,
including their relation in page 15/36 of the C
QM. SEE PHOTOS #2 & #3.
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
4.2.3q2a Is there a documented procedure that a) Ask for the procedure of document control, Yes, it described in the procedure (Q/YCQP-
defines the controls needed for approve and note its doc. nb and current revision in the 2012-2011), step 6.2. The authority
INTERNAL documents for adequacy report. regarding document review and approval is
prior to issue? b) Check if this procedure contain clear defined in the procedure (Q/CYQP-2012-
ISO/TS 16949:2009, Art 4.2.3 requirements need for: - 2011, B/0) page 6/6.
Ensuring the legibility and identification
C
- Authorities for approve prior to issue -
Ensure that only latest rev. at workplace
- Ensure the identification of changes
4.2.3q2f Is there a documented procedure that a) Ask if there is a masterlist containing all Yes, the is requirements for the control of
defines the controls needed for ensure documents for QMS, with doc title, doc. Nb. external documents (Q/YCQP-2012-2011,
that documents of EXTERNAL origin are Current revision. And distribution record / name step 6.8). There is a masterlist of external
identified and their distribution of users. document written in form (Q/YCQP-4012-
controlled? b) Select few docs from the masterlist, and 07, a/1). An obsolete stamp is putted in the
ISO/TS 16949:2009, Art 4.2.3 cross check on site (User hands) if these docs drawing for identification. SEE PHOTO #12 C
have same doc. nb, rev. Nb, and accurate nb of of drawing Nb. SA14056-D as example.
copy distributed.
4.2.3q2g Is there a documented procedure that a) Ask the responsible to explain how to prevent Yes, there are requirements for the control
defines the controls needed for prevent the use of obsolete documents. b) Check of external documents (Q/YCQP-2012-
the unintended use of obsolete if there is a documented procedure for: 2011, step 6.8). There is a master list of
documents, and to apply suitable - Identification of obsolete doc. external documents written in form
identification to them if they are retained - Retention period and location c) (Q/YCQP-4012-07, a/1). An obsolete stamp
for any purpose? Note the doc nb. and current rev. in this report. is putted in the drawing for identification. C
ISO/TS 16949:2009, Art 4.2.3 SEE PHOTO #12.
Is there any evidences of how to easily a) Check if there is visible "UNDER CONTROL" Yes, document has OBSOLETE stamp
identify obsolete documents to prevent stamp on new revised doc, and if there is putted in the drawing, SEE PHOTO #12 of
them for unintended use? "OBSOLETE" stamp on old rev. of same doc. drawing Nb. SA14056-D as example.
ISO/TS 16949:2009, Art 4.2.3 b) Note doc. Nb reviewed and take photo of C
those stamps if any.
T4.2.3.1q2 Does the review occur in two weeks or Check if the company includes time spent to Yes, the requirement to complete the
less? implement. review and distribution is been defined for
ISO/TS 16949:2009, Art 4.2.3.1 two weeks in the (Q/YCQP2012-2011, C
section 6.8.2)
T4.2.3.1q3 What records do you have showing a) Check if the company maintains a record of Yes, records are available.
implementation dates of changes? Is changes in engineering specifications from
there evidence showing that documents customers or regulatory or industry documents?
are updated? ISO/TS 16949:2009, Art b) Randomly select two cases from the list, and
4.2.3.1 ask them to show you record of implementation C
of such changes in others documents (ie
FMEA, Control Plans...etc).
ISO/TS 16949 QMS Audit Form Rev.
AUDIT CHECKLIST 0
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
4.2.4 Control of Records
4.2.4q1 What records exist that provide evidence a) Check if the company has a masterlist that The company has a masterlist of records
of conformity to requirements and of the with all quality records with detail of: that must be maintained in the factory, with
effective operation of the QMS? (Should - Name / template nb. details of their location and retention period,
be reviewed throughout the audit) - Creation method (handwriting / elec) SEE PHOTO #11.
ISO/TS 16949:2009, Art 4.2.4 - Resp. for initiate and approve.
- Retention period / location C
- Saving form (in paper or electronic)
- Disposal method after expiration.
b) Take photo of the masterlist
4.2.4q2 Are records legible, readily identifiable Should be reviewed throughout the audit. Yes, records are available
and retrievable?
ISO/TS 16949:2009, Art 4.2.4 C
4.2.4q3 Does Organization have a documented Review the procedure and note its doc. nb and Yes, the procedure (Q/YCQP2013-2011)
procedure defining the controls needed current revision. provide guidelines for the control of records
for the identification, storage, protection, listed in the masterlist.
retrieval, retention time and disposition C
of records? ISO/TS
16949:2009, Art 4.2.4
T4.2.4.1q1 Have the record requirements been Should be reviewed throughout the audit. Yes, records are to be review by a
reviewed to ensure conformance with Review few records at every process to see if supervisor, with signature as conformity.
regulatory and customer requirements? there is signature / name of the operator and for
ISO/TS 16949:2009, Art 4.2.4.1 the reviewer and approver. C
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.1q1a Does top management communicate the a) Review records (with attendance) of meeting Yes, the communication of customer will be
importance of meeting customer and held by top management. b) communicated to members following the
statutory and regulatory requirements to Review records of meeting related to any new APQP process, to be checked during
the organization? project. product/ process realization, with record C
attached.
5.1q1b Has a company quality policy (QP) been a) Check if there QP documented, hand signed Yes, the Quality Policy is documented in
established? (See 5.3) by top management. the Quality Manual (Q/YCQP1001-2011, rev
b) Check if QP is posted in public board for all C), published and signed by GM. SEE
employees to view. And, eventually take a PHOTO #9. C
photo of it.
5.1q1c Has company established quality a) Check if the quality objectives are hand Yes, quality objectives are also listed, with a
objectives and communicated all signed by all managers and published. distribution to each department. SEE
members? (See 5.4.1) b) Ask them to explain and demonstrate that PHOTO #7.
quality objectives are aligned to fit with policy. C
5.1q1d Does top management conduct a) Check if there a documented as guideline to Yes, the factory has a procedure for
management reviews? (See 5.6) conduct management reviews, and note the management review (Q/YCQP-2016-2011,
doc. nb / rev. B/0). The last management review was
b) Review record of last two management conducted in 20XX-12-21. There is a form
C
reviews. for plan. (Q/HLQP-4016-01)
5.1q1e Does top management ensure the a) Manpower list at each position The factory does not have a replacement
availability of resources to support and b) Machine and facility person for lab testing.
continually improve the QMS? I
T5.1.1q1 Does top management review product Yes, the factory uses a multi-functional
realization and support processes to team, with a delegate to supervise the
ensure effectiveness and efficiency? process. Records are available. C
(5.6?)
ISO/TS 16949 QMS Audit Form Rev.
AUDIT CHECKLIST 0
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
5.2 Customer Focus
5.2q1 Has top management ensured that a) Check if there is any responsible person or Yes, the company has nominated a
customer requirements are determined group dedicated for identification of customer responsible party to act as Customer Rep.
and met with the aim of enhancing requirements. with responsibility to ensure that customer
customer satisfaction? b) Check if there any records showing a list of requirements are determined. SEE PHOTO
identified requirements per customer, and #13. (Q/YCQP1001-2011, page 5/36).
related procedures or method applied to fit The factory also maintains a record
them. describing all customer requirement C
records. (Q/YCQP-4003-32-2012) SEE
PHOTO #14.
5.3q1b Does the quality policy include a Read the quality policy. Yes, the quality policy includes a
commitment to comply with commitment to comply with requirements
requirements and continually improve and continually improve QMS effectiveness. C
QMS effectiveness?
5.3q1c Are the contents of the quality policy Read the quality policy and ask them to explain Yes, the contents of the quality policy
relevant to the organization and how the company measures them. relevant to this factory are measurable with
measurable? KPIs defined, SEE PHOTOS #7 AND #8 for
the year 20XX. There is plan of how these C
KPIs are monitored. SEE PHOTO #8.
5.3q1d Is the quality policy communicated and a) Check if there is QP documented and hand Yes, the Quality Policy is documented in
understood within the organization? signed by top management. the Quality Manual (Q/YCQP1001-2011, rev
b) Check if QP is posted in public board for all C), published and signed by GM, posted in
employees to view. published place visible by all. SEE PHOTO C
#9.
5.3q1e Is there an established process to review Yes, from management review meeting.
the quality policy for continuing
suitability? C
5.4 Planning
5.4.1 Quality Objectives
5.4.1q1 Has top management established quality Check if the quality objectives are hand signed Yes, quality objectives are also listed, with a
objectives (including those needed to by all managers and published. distribution to each department. SEE
meet requirements for product) at PHOTO #7. C
relevant functions and levels within the
organization?
5.4.1q2 Are the quality objectives consistent with a) Ask them to explain how quality objectives Yes, the quality objectives are consistent
the quality policy? What are the are aligned to fit with quality policy. with the quality policy. SEE PHOTO #8.
measurements? b) Review record of measurement of last year,
and for this year.
c) Check if the result are published and take a C
photo of quality objectives.
T5.4.1.1q1 Are quality objectives and metrics Check if the quality objectives are hand signed Yes, it is included. SEE PHOTO #8.
included in the business plan? by all managers and published.
C
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
5.4.2q1b How do you ensure that the integrity of a) Check if there is a document as guideline to Yes, following the procedure (Q/YCQP2010-
the QMS is maintained when changes to handle any changes that could potentially 2011), with responsibility under Manager of
the QMS are planned and implemented? happen, note doc. nb / rev. Technical Department.
b) Check if the company has a reaction plan
with responsible for implementing changes. C
T5.5.1.1q1 Are managers responsible for corrective a) Check if there a document that describes the Yes, it is implemented accordingly and
action informed of nonconforming flow for the communication of quality issues, records are available.
products or processes? and note the doc. nb / rev.
Are they informed in a timely manner? b) Check if a record of internal / external C
complaints are maintained.
T5.5.1.1q2 Do personnel responsible for product Review JD for Quality Manager / Supervisor Yes, it is defined in the JD of the Quality
quality have the authority to stop and check if this is included. Department, No. 9.
production to correct quality problems? C
T5.5.1.1q3 What personnel on each shift have Check if there is a representative of the Quality Yes, each facility under this organization
responsibility for ensuring product Department in charge of quality for the whole has responsibility of quality to ensure the
quality? company. Note his/her name. quality of product. C
5.5.2q1a Does the MR have responsibility and Review JD for MR and check if this is included. Yes, it is included.
authority to ensure that processes
needed for the QMS are established, C
implemented and maintained?
5.5.2q1b Does the MR have the responsibility to a) Review the organization chart and the Yes, it is included.
report to top management on the position of MR, including report line.
performance of the QMS and any need b) Review his last report submitted to top C
for improvement? management (Is this signed by the MR?)
5.5.2q1c Does the MR have the responsibility to Review JD for MR, and check if this is included. Yes, it is included.
ensure the promotion of awareness of
c
customer requirements throughout the
organization?
T5.5.2.1q1 Has top management designated as Check if there is nomination letter, take photo of Yes, it is defined in the QM, page 5/36.
Customer Representative to ensure that that letter.
C
customer requirements are addressed?
T5.5.2.1q2 Does their responsibility and authority Review JD for customer representative and Yes, it is included.
include selection of special check if this is included.
characteristics, setting quality objectives
and related training, corrective and C
preventive actions, product design and
development?
ISO/TS 16949 QMS Audit Form Rev.
AUDIT CHECKLIST 0
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
5.5.3 Internal Communication
5.5.3q1 How is information regarding the a) Check if the company has defined clear The method of communication is defined in
effectiveness of the QMS communicated methods (email, fax, telephone, meeting, paper related procedure, and change depending
within the organization? record) for communication of information. to the type of information. Email, ERP
b) Check if the implementation of these are system mainly is used, including public
effective and their efficiency monitored (On time board, to inform about performance. SEE C
delivery, accuracy). PHOTO #15.
5.6.1q2 What kinds of information are reviewed Check the scope of management review According to the last management review
in management reviews? (Must include suitability, adequacy and effectiveness of QMS; conducted in 20XX-12-21, following are
suitability, adequacy and effectiveness of improvement; & changes to the QMS, quality reviewed written in Q/YCQP-4016-03 (a/0):
QMS; improvement; & changes to the policy and objectives. - Policy and objective
QMS, quality policy and objectives) - Last internal audit record - C
Improvement opportunity
5.6.1q3 Can you show me records from recent Check records of last two management reviews Yes, reviewed the record of last
management reviews? and compare status of improvement between management review conducted in 20XX-12-
both. 22. C
T5.6.1.1q1 Do management reviews include all Verify records of last two management reviews. Record of review are checked for the year
requirements of the quality management 20XX. Performance trends of the year 20XX
system and performance trends? (Verify recorded in document ( Q/YCQP-4016-05, C
records) B/0).
T5.6.1.1q2 Can you show management review Verify records of last two management review. Yes, recorded in the form Q/YCQP-4016-
records including monitoring of quality 05, B/0)
objectives, and cost of poor quality C
metrics? (Verify records)
T5.6.1.1q3 Can you show records providing Verify records performance of each objectives Record are available. SEE PHOTO #16.
evidence of achievement of the quality and take photo.
objectives specified in the business plan, C
and customer satisfaction with product
supplied?
5.6.2 Review input
5.6.2q1 Can you show me that each of the a) Verify if there is document specifying the type Yes, all inputs are included in the file
following were included in review(s)? of input for the management review and note Q/YCQP-4016-03 (a/0).
a) results of audits, the doc. nb/ rev. b)
b) customer feedback
Verify if all mandatory inputs are listed, and
c) process performance and product conformity
d) status of preventive and corrective actions include evidences for the last two management
e) follow-up actions from previous management review meeting. C
reviews
f) changes that could affect the quality management
system, and
g) recommendations for improvement
T5.6.2.1q1 Do records show input to management Did not include PFMEA as input to
review includes analysis of actual and management review.
potential field-failures and their impact? I
(See also 7.3.4.1)
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
6 RESOURCE MANAGEMENT
6.2 Provision of Resources
6.1q1a What resources has the organization Review factory profile. The factory provided manpower resource
provided to implement and maintain the for the QMS, and ERP system for internal
QMS and continually improve its communication, etc. C
effectiveness?
6.1q1b What resources has the organization Evidence on question (See 6.2, 6.3, 6.4) will be The factory has all necessary workshops,
provided to ensure that customer acceptable. and equipment, including lab service. SEE
requirements are met? PHOTOS #5, #6, AND #17. TESTING
(See 6.2, 6.3, 6.4) CENTER - SEE PHOTOS #18, #19, #20, C
#21, #22.
6.2.2q1b What training or other actions do you a) Verify if a periodical (annual) training plan is There is an annual training program
provide to satisfy the needs of documented. documented in the file (Q/YCQP-4017-14-
personnel? b) Take a photo of the training program. 2012) for the year 20XX, and approved by
the leader in 20XX-01-07. SEE PHOTO C
#25.
6.2.2q1c When you provide training or other a) Verify if there is method for evaluating The method of evaluation is defined in the
actions to satisfy competence needs, effectiveness of training provided, and name of file (Q/YCQP-4017-14-2012). SEE PHOTO
how do you evaluate the effectiveness of examiner. #26.
those actions? (records) b) Verify of the trainer is the same peron that C
conduct evaluation.
6.2.2q1e Where do you maintain records of Select three training topics from the training Yes, records are available. SEE PHOTO
education, training, skills and program, and verify if related training records #27.
experience? are available and fit with the program. C
T6.2.2.1q1 What tools and techniques has the a) Verify if Autocad, Pro/E…ERP system or any The factory has identified specific design
organization identified as necessary for similar system is applied for design personnel. software such as PRO / E, Autocad and
product design personnel? b) Note revision number of those design tools. solid work.
C
T6.2.2.1q2 What records do you have showing that Verify design personal skill matrix and related Training of technical people has been
product design personnel are competent certificate / training record. planned in the document (Q/YCQP-4-17-14-
to design and are skilled in the identified 2012) for the current year, for Autocad,
tools and techniques? GB2828, ERP system, SEE PHOTO #28.
No record to attest the capability of I
employee having skill in PRO / E. for
example.
T6.2.2.2q1 Can you show me documented Check the existence of the procedure, and note Yes, the record of training are available in
procedures for identifying training needs doc. nb / rev. the document (Q/YCQP-4017).
and achieving competence of all C
personnel performing activities affecting
product quality?
ISO/TS 16949 QMS Audit Form Rev.
AUDIT CHECKLIST 0
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
T6.2.2.2q2 What records do you have that a) Verify record of training / certificate of Training of technical people has been
personnel performing specific assigned personnel performing key process (for planned in the document (Q/YCQP-4-17-14-
tasks are qualified - especially to meet example). 2012) for the current year, for Autocad,
customer requirements? (See 6.2.2e) b) Verify record of training / certificate of GB2828, ERP system. SEE PHOTO #28.
personnel for specific client requirement, note No record to attest the capability of I
the specific client is possible. employee having skill in PRO / E, for
example.
T6.2.2.3q1 What kinds of on-the-job training do you Review the records, if any. Record of training are available. Contract
provide for people in new or changed and agency are not used in this factory.
jobs? Does this include contract and C
agency personnel?
T6.2.2.3q2 How do you inform personnel about the Select a few workers at the manufacturing area, By meeting, and posting of process files on
consequences to the customer of and ask them to show the defect part and site as work instruction and red sign on
nonconformity to quality requirements? explain the consequence of this defective part. specify product/process characteristic. SEE
C
(Sample throughout organization) PHOTOS # 29 & #30.
T6.2.2.4q1 What process has been established to a) Any promotion activities? 1. Salary increase of 10% to 15%
motivate employees to b) Employee satisfaction survey and record? 2. KPIs are published on site.
- achieve quality objectives c) Are KPIs published at each workplace for 3. Employee satisfactory survey
- to make continual improvements, and employee to review? (Q/YCQP 4021-05) conducted in 20XX-11- C
- to create an environment to promote 20, and summarized in Q/YCQP4021-06.
innovation
T6.2.2.4q2 Does the process include the promotion a) Is the promotion documented and Yes, a promotion is planned to enforce
of quality and technological awareness communicated ? quality and technological awareness
throughout the whole organization? b) Any evidence records for quality / throughout the whole organization. SEE
technological? PHOTO #31. C
T6.2.2.4q3 What process has been established to a) Is there any questionnaire test for employee Yes, there is questionnaire test applied as
measure the extent to which personnel to evaluate their knowledge? part of test exam. SEE PHOTO #26.
are aware of the relevance and
importance of their activities and how C
they contribute to the achievement of the
quality objectives?
(See 6.2.2d)
6.3 Infrastructure
6.3q1a Are the buildings, workspace and utilities a) Visit the facility, specially the condition of how Yes. SEE PHOTO #5, #6 & #17.
provided appropriate to achieve product / material are stored.
conformity to product requirements? b) Verify if the factory has a maintenance
How are they maintained? program. C
6.3q1b What kind of process equipment (both Listed in the factory profile, take photos. Yes, for client, only need an assembly line.
hardware and software) is necessary to SEE PHOTOS #32, #33 & #34. The factory
conform to product requirements? How also has a stamping workshop. SEE
is the equipment maintained? PHOTOS #5 & #6. C
6.3q1c What supporting services (such as Listed in the factory profile and take photos. Yes, the factory use automatic conveyor at
transport or communication) are needed the painting process.
to ensure that product meets C
requirements? How are they
maintained?
6.3.1 Plant, Facility and Equipment Planning
T6.3.1q1 What groups are involved in developing Verify if there is map route describing position The maintenance department is in charge
plant, facility and equipment plans? of machine, storage of material, moving of of this. There is visible map route and
(Must be multidisciplinary) people. layout at each workshop. SEE PHOTO #35.
C
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QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
T6.3.1q2 Can you show that plant layouts a) Is the pathways visible defined for material Yes, the plant layouts optimize material
optimize material travel, handling and storage, machines position and peoples travel, handling and floor space use, and
floor space use, and facilitate rotation? Take photo. facilitate synchronous material flow. SEE
synchronous material flow? b) Is the direction of moving clearly marked? PHOTOS #5 & #6. C
T6.3.1q3 What methods are used to evaluate and Record of periodical evaluation of time used to With periodical evaluation of each process.
monitor the effectiveness of existing move material from this location to another
operations? place, a long a certain pathway. C
T6.4.1q1 How are product safety and potential Each machine has user manual visible.
risks to employees addressed by the Could better be written with images that
organization? indicate what to do when using it, both at
workshop and testing center. I
T6.4.2q1 Does the organization maintain the state Yes, it is clean and well organized at the
of order, cleanliness and repair needed stamping plant and assembly plant.
for products and manufacturing C
processes? (Verify throughout audit)
7 PRODUCT REALIZATION
7.1 Planning of Product Realization
7.1q1 Are the processes needed for product Verify if there a process map or flow chart for Yes, the guidelines are described in the
realization identified? product realization and note doc nb / rev. procedure (Q/YCQP2004-2011), under
responsibility of production department. C
7.1q2 Is the planning of product realization Check the relation between this process with Defined with previous process as marketing
consistent with the requirements of the others process. Define where it gets input and dev, order review, product development,
other processes of the QMS? Verify where its output goes. and with next process as continuous
C
there are no inconsistencies or conflicts improvement.
between quality system procedures.
7.1q3a Where in the product realization process a) Verify if the step for the identification of product Yes, it planned, as for example of the
do you determine the quality objectives requirements are planned. development of product / project #198911-
and requirements for products? b) Check if there a record as example of any E. SEE PHOTO #36. The identification is
product. planned with the output recorded in the C
form (Q/YCQP-4003-32-2012).
7.1q3b When planning for product realization, a) Verify if there is planning. The planning of production realization is
how do you establish processes, b) Check if there a record as example of any documented as project planning such as for
documents, and provide resources product. the case of project #198911-E. SEE C
specific to the product? PHOTO #36.
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7.1q3c How do you determine verification, a) Verify if there is planning defining method for The stage of verification, validation and
validation, monitoring, inspection and verification, validation…etc. monitoring of production realization are
test activities specific to the product, and b) Check if there a record as example of any documented as project planning such as for
the criteria for product acceptance? product. the case of project #198911-E. SEE C
PHOTO #36.
7.1q3d What records exist showing that both the Check if there a record as example of any Records of the four stages are available,
realization processes and the product product. example of the project #198911-E.
C
meet requirements?
7.1q4 What are the outputs of product Verify if there a documented planning. Yes, forms are used to record output of the
realization planning? Are they in a form product realization.
suitable for the organization? C
T7.1.2q2 When attribute data sampling, is the Check the inspection criteria. Yes, the acceptance level zero defects is
acceptance level zero defects? applied. C
7.1.3 Confidentiality
T7.1.3q1 How does the organization ensure the By customer property (Q/YCQP2005-2011).
confidentiality of customer-contracted
products, projects under development, C
and related product information?
T7.1.4q5 Do you have evidence that any Yes, records are available.
additional verification/identification
requirements required by the customer C
are met?
7.2.1q1b Does the organization determine not Yes, it included in the document (Q/YQCP-
stated by the customer but necessary for 4003-32-2012). SEE PHOTO #14.
specified or intended use, where known? C
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
7.2.1q1d Does the organization determine any Yes, it is included in the document
additional requirements determined by (Q/YQCP-4003-32-2012). SEE PHOTO
the organization. #14. C
T7.2.1.1q1 Does the organization meet customer Yes, all requirements are meet according to
requirements for designation, the PSW signed by CVGS.
documentation and control of special C
characteristics?
7.2.2q4 When product requirements are According to change procedure. There are
changed, how do you ensure that a few examples of how changes were
relevant documents are changed and implemented. C
that relevant personnel are made aware
of the changes?
T7.2.2.2q1 What documents do you have that show Yes, there are few case where feasibility
investigation and confirmation of were conducted.
manufacturing feasibility in the contract
C
review process for proposed products,
including risk analysis?
Do your customers require information to Yes, specific format to use, and in English
be communicated in specific languages must of the time. The factory has people
and/or formats? with English capability, such as Ms. XXX,
C
If so, how do you meet those the Customer Rep.
requirements?
7.3.1q2a What are the stages in the design and There are four stages for the development,
development process? for example of the project CVGS (OEM), for
part 198911-E, the plan is documented in
Q/YCQP4003-04. C
7.3.1q2b Are the review, verification and validation Yes, there are review, verification and
activities appropriate to each design and validation at each stage. Example of part
development stage planned? 198911-E, the plan is documented in
C
Q/YCQP4003-04.
7.3.1q2c Are design and development Yes, responsibility is well defined. Example
responsibilities and authorities defined? of part 198911-E, the plan is documented in
Q/YCQP4003-04. C
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QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
7.3.1q3 How does the organization ensure Yes, responsibilities are well defined.
effective communication and clear Example of part 198911-E, the plan is
assignment of responsibility between documented in Q/YCQP4003-04. C
different groups involved in design and
development?
T7.3.1.1q1 Do you use a multidisciplinary approach NOTE A multidisciplinary approach typically Yes, there is multidisciplinary approach,
to prepare for product realization? Does includes the organization's design, manufacturing, with mission to develop and finalize special
it include: engineering, quality, production and other characteristic, record are available
- development/finalization and appropriate personnel.
monitoring of special characteristics
C
- development and review of FMEAs,
including actions to reduce potential
risks,
- development and review of control
plans.
7.3.2 Design and Development Inputs
7.3.2q1a What are the design inputs relating to The factory does not have design
each of the following product responsibility.
requirements?
a) functional and performance
requirements
b) applicable statutory and regulatory
N/A
requirements
c) where applicable, information derived
from previous similar designs, and
d) other requirements essential for
design and development.
Where are they recorded?
7.3.2q2 How & when are the design inputs The factory does not have design
reviewed for adequacy? responsibility.
N/A
7.3.2q3 How does the organization ensure that NOTE: Special characteristics (see 7.2.1.1) are The factory does not have design
requirements are complete, included in this requirement. responsibility.
unambiguous and don’t conflict with N/A
each other?
T7.3.2.3q1b Are the customer-specified (or Yes, customer-specified symbols are used
equivalent) symbols 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 Yes, customer-specified symbols are used
special characteristics? in PFD, PFMEA, CONTROL PLAN and
work instruction. SEE PHOTOS #29 & #30. C
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7.3.3 Design and Development Outputs
7.3.3q1 How can design and development Outputs of development are verified by
outputs be verified against the inputs? dimensional checking, and compared to
(see 7.3.5q1) Are these outputs requirements. Records are maintained. C
approved prior to release?
T7.3.3.1q1 Can you show that the product design Not applicable.
outputs include
- 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 N/A
- 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 The manufacturing process design output shall be Yes, the outputs include all the data, full
process design outputs include expressed in terms that can be verified against dimension report (Q/YCQP-4003-13), PFD,
- specifications and drawings, manufacturing process design input requirements PFMEA, Control plan (Q/YCQP-4003-30),
- manufacturing process flow chart/ layout,
and validated. Ppk (Q/YCQP-4003-18), etc.
- manufacturing process FMEAs,
- control plans,
- work instructions,
- process approval acceptance criteria,
- data for quality, reliability, maintainability and C
measurability
- results of error-proofing activities, as appropriate,
and
- methods of rapid detection and feedback of
product/manufacturing process nonconformities.
7.3.4q3 Can you show me records of the results SEE PHOTO #39.
of the reviews and any necessary
actions taken? C
7.3.5q2 Can you show me records of the results SEE PHOTO #40.
of the verification activities and resulting
actions? C
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
T7.3.6.1q1 Is design and development validation Yes, the customer will conduct the
performed in accordance with customer validation .
requirements, including program timing? C
7.3.7q2 Are changes reviewed, verified, Yes, changes are reviewed, verified,
validated, and approved before validated, and approved before
implementation? implementation. Records are available. C
7.4 PURCHASING
7.4.1 Purchasing Process
7.4.1q1 How do you ensure that purchased The factory has a procedure as guideline
product conforms to specified purchase for ensuring the conformity of product
requirements? (Q/YCQP2019-2011). C
7.4.1q2 How do you determine the type and The factory has a master list of qualified
extent of control applied to the supplier supplier recorded in the form Q/YCQP-4019-
and the purchased product? 03. SEE PHOTO #42.
C
7.4.1q3 How do you evaluate and select The factory will conduct investigation of the
suppliers based on their ability to supply supplier and record it in the Q/YCQP-4019-
product in accordance with the 05. C
organization’s requirements?
7.4.1q4 Can you show me the criteria for Yes, records are available.
selection, evaluation and re-evaluation C
of suppliers?
7.4.1q5 Can you show me records of the results Yes, recorded in the form Q/YCQP-4019-
of supplier evaluations and any 06, conducted in 20XX-01-20 as yearly
necessary actions? Verify that criteria evaluation approved by General Manager,
have been met. with hand signed by himself. SEE PHOTO C
#43.
T7.4.1.1q1 What evidence is there that all The factory conduct monthly evaluation of
purchased products or materials used in each supplier about QUALITY (40),
product conform to regulatory DELIVERY(20), SERVICE(20) and
requirements? PRICE(10), and data is recorded
automatically in the ERP system in the form C
Q/YCQP-4019-07.
T7.4.1.2q1a What supplier development actions are Yes, two suppliers have provided
being taken toward the goal of supplier commitment to achieve the goal of TS
conformity with TS 16949? certification by the end of the year 20XX.
One out of twenty-one has passed the TS, I
SEE PHOTO #44.
T7.4.1.2q1b Do your suppliers’ quality management NOTE: The prioritization of suppliers for Yes, 13 suppliers are certified to ISO 9001,
systems conform with ISO 9001:2000? development depends upon, for example, the and those suppliers are more important.
supplier’s quality performance and the importance C
of the product supplied.
T7.4.1.2q2 Are all of your suppliers registered to Yes, 13 suppliers are certified to ISO 9001,
ISO 9001:2000? and those suppliers are more important.
If not, do you have written waivers from C
applicable customer(s)?
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QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
T7.4.1.3q1 Do your customer(s) specify supplier(s) Yes, all information is included in the plan.
in contracts/ purchase orders? The factory has a written program to
This includes products, materials, monitor suppliers.
services, tooling, & gages, etc.
If so, can you show that the customer- C
designated sources are being used as
required?
7.4.2q2 How does the organization ensure the Communication is done by email, or
adequacy of purchasing requirements physically with sign from supplier in the
before communicating them to the purchase order. C
supplier?
T7.4.3.1q1 What processes are in place to assure Must include one or more of following: Incoming inspections are conducted
the quality of purchased product? - evaluation of supplier statistical data following criteria defined in file (Q/YCQP -
- receiving inspection and/or testing 3023-03-2012). SEE PHOTO #45. And
- second- or third-party audits of suppliers, along records are maintained in form (Q/YCQP -
with records of acceptable quality 4023-03-2012). SEE PHOTO #46. C
- laboratory part evaluation
- another method agreed with the customer
T7.4.3.2q1 How do you monitor supplier Must include the following indicators: The factory conducts monthly evaluation of
performance? - delivered product quality each supplier about QUALITY (40),
- customer disruptions including field returns DELIVERY(20), SERVICE(20) and
- delivery schedule performance (including PRICE(10). Data is recorded automatically
incidents of premium freight) in the ERP system in the form (Q/YCQP-
C
- special status customer notifications related to 4019-07). SEE PHOTO #47.
quality or delivery issues
7.5.1q1b When carrying out production (or Yes. SEE PHOTO #29.
service) are appropriate work
instructions available if needed? (See C
7.5.1.2)
7.5.1q1c When carrying out production (or Yes, equipment is available.
service) is suitable equipment used for
carrying out production (or service)? C
ISO/TS 16949 QMS Audit Form Rev.
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7.5.1q1d When carrying out production (or Yes, gages are available.
service) are appropriate gages, etc.
used in production (or service)? (See C
7.6)
7.5.1q1e When carrying out production (or Yes, necessary monitoring is conducted,
service) are appropriate kinds of according to in-process inspection.
monitoring and measurement done? C
(See 8.2.4)
T7.5.1.1q2 Can you show me control plans for both Yes, there is a control plan developed for
pre-launch and production? each product in which a PPAP has been
required. SEE PHOTO #48. C
T7.5.1.1q3 Can you show how the control plans Yes, there is control plan developed for
take into consideration design FMEA each product in which a PPAP is been
and process FMEA information? required. SEE PHOTO #48.
C
(See Annex A)
T7.5.1.1q4 Can you show that specified reaction SEE PHOTO #48.
plans have been carried out when a
C
process becomes unstable or not
statistically capable?
7.5.1.2 Work Instructions
T7.5.1.2q1 Do all employees responsible for Verify throughout audit. Yes. SEE PHOTOS #29 & #30.
processes that impact product quality
have documented work instructions? Are C
they accessible for use at the
workstation?
T7.5.1.2q2 How are the work instructions SEE PHOTOS #29 & 30.
developed? C
T7.5.1.3q2 What work instructions do you have for Yes. SEE PHOTOS #29 & #30.
job setup personnel?
C
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
T7.5.1.4q2 What predictive maintenance methods Accident occurrence are recorded in the
do you use? Can you demonstrate that form Q/YCQP4006-08 and their root cause
predictive maintenance has resulted in is investigated in the form Q/YCQP-4006-06
continual improvement of the (B/0). See example of machine #YC29.
effectiveness and efficiency of Data collected are not properly used to I
production equipment? develop an efficient predictive action.
T7.5.1.5q3 Do you have space for storage, recovery Yes, the factory has special place for the
and set-up of tooling? storage of tooling. C
T7.5.1.5q4 Do you have perishable tool change There is accumulation time of use in the
programs? 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 I
reaction of what do to after reach the time.
T7.5.1.5q6 Tool identification, defining the status, Tool are well identified and protected. SEE
such as production, repair or disposal. PHOTOS #17 & #49.
C
T7.5.1.5q3 Are any tooling management activities Yes, some tolling is outsourced.
outsourced? If so, how are these
activities monitored? C
How is product inspection status Each product has label to indicate its detail
identified? Verify in production, storage, and status. SEE PHOTO #50.
segregation areas, etc. C
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
7.5.4 Customer Property
7.5.4q1 Do you use any customer-owned Yes, the factory use customer drawing,
property, such as product, packaging, tooling as customer property.
drawings, tooling, gages, etc N/A
If so, ask questions below.
7.5.4q2 How do you ensure that customer- Customer property is controlled as defined
owned property is identified, verified, in the procedure (Q/YCQP2005-2011).
protected, and safeguarded? C
T7.5.4.1q1 How are customer-owned tools and Customer-owned tools and equipment
equipment identified? identified are identified with customer name
and part number. C
7.6q3a How do you ensure that measuring and External calibration is conducted as
test equipment is calibrated or verified planned, and are traceable to external
proper frequencies with NIST traceable national institute.
standards? If no such standards exist, C
where do you record the basis used for
calibration or verification?
7.6q3c How are measuring tools identified to With tags visible at each device.
enable the calibration status to be
determined? C
7.6q3e How do you ensure that measuring its Equipment is well protected in the testing
test equipment is protected from center under acceptable room condition.
damage and deterioration during SEE PHOTOS #18, #19, #20, #21, #22 & C
handling, maintenance and storage? #23.
7.6q4 When equipment is found to be out of There is no specific plan as reaction plan in
calibration, how do you assess and the case of out of calibration found, and
record the validity of the previous others damage. NC
measuring results?
7.6q5 What actions do you take on the There is no specific plan as reaction plan in
equipment and any product affected? the case of out of calibration found, and
others damage. I
7.6q6 Can I see your records of the results of Yes, record of in-house are available by
calibration and verification? computerized. No signature of the person
assigned for the in-house calibration. I
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QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
7.6q7 Do you use computer software for External calibration is conducted as
monitoring and measurement? If so, is planned, and are traceable to external
its ability to perform that function national institute, while calibration in house
confirmed prior to initial use and does not provide evidence of such
reconfirmed as necessary? traceability to that external national institute. I
T7.6.1q1 Can you show me R&R studies for each Is there other statistical studies analyzing the GR&R is conducted for related equipment
type of measuring and test equipment variation in measurement & test results? used to conduct product to which PPAP
system referenced in the control plan? were required. C
T7.6.1q2 Do the methods and acceptance criteria Yes, the AIAG format is no longer used.
conform to those in customer reference
manuals on MSA or does the customer C
approve them?
T7.6.2q7 Notification to the customer if suspect Not planned, but has never happened.
product or material has been shipped?
I
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 General
8.1.1 Identification of statistical tools
T8.1.1q1 Have appropriate statistical tools for Yes, appropriate statistical tools for each
each process been determined and process has been determined in the
included in the control plan? (See procedure (Q/YCQP2024-2011), where
7.5.1.1) SPC are used at process, and graphical
statistic of conformity rate applied to each C
process and result displayed. SEE PHOTO
#15.
T8.2.1.1q1 What realization process performance Do they include at least: Client complaint log and customer
indicators are used to monitor customer - delivered part quality performance satisfaction surveys are used, including
satisfaction? - customer disruptions including field returns internal OTD.
- delivery schedule performance (including
incidents of premium freight), and C
- customer notifications related to quality or
delivery issues
T8.2.1.1q1 How do you monitor manufacturing The manufacturing is monitored with daily
processes to demonstrate compliance rate evaluation and at some process with
with customer requirements for product SPC system. C
quality and process efficiency?
8.2.2q2 Can you show me an audit plan that Yes, there is the audit plan described in
takes into consideration the importance Q/YCQP-4022-01 (a/0), nb. 2013001, and
of the processes and areas to be approved in 20XX-02-09. C
audited, and the results of previous
audits?
8.2.2q3 Where are the audit criteria, scope, Yes, the scope of the audit is described in
frequency and methods defined? the Q/YCQP-4022-01 (a/0).
C
8.2.2q4 Can you demonstrate that selection of The factory has 12 auditors. And it requires
auditors and the conduct of audits are to avoid auditors to be organized
objective and impartial, and that auditors independently to their process. C
don’t audit their own work?
ISO/TS 16949 QMS Audit Form Rev.
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8.2.2q5 Can you show me your internal audit Yes, records of internal audit are available,
procedure? Can you show me the see photo Q/YCQP-4022-08.
records of internal QMS audits? C
8.2.2q6 Who ensures that actions are taken to The MR is in charge to ensure that NCF are
eliminate detected nonconformities and solved, and recorded maintained, see photo
their causes? Are they being taken care , Report nb. 2013-NA-001 for article
of in a timely manner? (verify with TS16949-7.3.6 C
records)
T8.2.2.1q1 Do you have audit records showing that Yes, records are available.
the entire QMS is being audited?
C
T8.2.2.2q1 Do you have records showing that each Yes, each process was audited.
manufacturing process is being audited
to determine its effectiveness? C
T8.2.2.4q2 Is there evidence that audit frequency is No, not stated in the procedure.
increased due to nonconformances or
customer complaints? I
8.2.3q2 Can you show that they have achieved Some processes has KPIs displayed, with
the desired results? acceptable result such as for Supplier
Monitoring, while customer satisfaction
survey shows some need in improvement. C
8.2.3q3 When the desired results are not The result was reviewed during a
achieved, what actions are taken to management review meeting, and actions
ensure that the product meets are defined for improvement. C
requirements?
T8.2.3.1q1 Can you show me process studies that SEE PHOTO #52.
have been performed on new
manufacturing processes? N/A
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
T8.2.3.1q4 Do records show that manufacturing Yes, there are record that show that
process capability or original customer- process capability was evaluated and
approved performance is being approved by the client, thought PSW, see
maintained? the case of the client CVSG. C
T8.2.3.1q5 May I have a copy of the process flow The copy of PFD, and Control Plan are
diagram and control plan for (mfg. available.
process) to review the production line
C
with? Review for adherence to specified
requirements.
8.2.4q2 At what stages of the product realization At incoming Inspection (IQC), In-process
process do monitoring and measuring inspection (IPQC) and final inspection
activities take place? (FQC), mainly. SEE PHOTO #45.
C
8.2.4q3 How is evidence of conformity with Record are available. SEE PHOTO #46.
acceptance criteria maintained?
C
8.2.4q4 Can you show me records that indicate Record are available, SEE PHOTO #46
who has authorized release of product to
the next stage of the process? C
8.2.4q5 How do you ensure that product is not NOTE: When selecting product parameters to At incoming inspection (IQC), in-process
released until the all requirements have monitor compliance to specified internal and inspection (IPQC) and final inspection
been met? If product must be released external requirements, the organization (FQC), mainly. Work Instruction for the
prior to this, how is it approved? determines the types of product characteristics, implementation of such operation are
leading to available. SEE PHOTO #45. C
- the types of measurement
- suitable measurement means, and
- the capability and skills required
T8.2.4.1q1 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
C
control plan requirements?
Are results available for customer
review?
T8.2.4.2q1 Do you provide parts designated by If so can you show that you have: Yes, there are master for comparison, and
customer(s) as appearance items? If so, - appropriate resources including lighting for these master (standard) product are
what support to you have? evaluation approved by the client and put with proper
- masters for color, grain, gloss, metallic brilliance, identification to avoid mixing with others
texture, distinctness of image (DOI), as product.
appropriate
- maintenance and control of appearance masters C
and evaluation equipment, and
- verification that personnel making appearance
evaluations are competent and qualified to do so
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
8.3q2 Can you show me your documented The procedure Q/YCQP2024-2011 is
procedure defining the controls for available and defines responsibilities.
dealing with nonconforming product?
C
Does it include related responsibilities
and authorities?
8.3q3 When you have nonconforming product, a) by taking action to eliminate the detected
what methods do you use to deal with it? nonconformity
b) by authorizing its use, release or
acceptance under concession by a relevant
authority and, where applicable, by the
customer C
c) by taking action to preclude its original
intended use or application.
8.3q4 Can you show me records of Records are available, product is stored
nonconforming product and any actions with label at segregate area. SEE PHOTOS
taken? Are there any records of #53 & #54. C
concessions obtained?
8.3q6 When nonconforming product is Yes, actions are defined as to inform the
detected after shipment, what actions client.
are taken, such as containment? C
(Verify corrective action records)
What information does this analysis Internal / external PPM, OTD record,
provide relating to: supplier performance evaluation, NCF from
- customer satisfaction (See 5.6) internal audit, amounts others KPIs
- conformity to product requirements assigned, and customer satisfaction are
C
(See 5.6) collected.
- characteristics and trends of processes
and products (See 5.6)
- suppliers (See 7.4.1)
8.4.1 Analysis and Use of Data
T8.4.1q1 How do you compare trends in quality Data is used to compare trends in monthly /
and operational performance with annual basis and to display opportunities
progress toward objectives? from improvements. Decisions are taken
Does the comparison lead to action to during management review meetings.
supporting the following?
- development of priorities for prompt
solutions to customer-related problems
- determination of key customer-related C
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.
ISO/TS 16949 QMS Audit Form Rev.
AUDIT CHECKLIST 0
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
8.5 Improvement
8.5.1 Continual Improvement
8.5.1q1 Can you demonstrate that The internal audit is used a basic tool to
Organization’s QMS effectiveness demonstrate that the organization's QMS
continually improves? run effectively. C
What tools do you use?
(See 5.6, 8.2.2, 8.4, 8.5.2, 8.5.3)
T8.5.1.1q1 Where has Organization defined a The process for continual improvement is
process for continual improvement? defined in the procedure (Q/YCQP2026-
C
2011).
T8.5.1.2q1 Can you show that CI efforts focus on Yes, there are records of continual
control and reduction of variation in improvement. SEE PHOTO #31.
product and process characteristics after C
capability, stability, and conformity?
8.5.2q2 Are actions taken appropriate to the Yes, for example of the case #130060 on
severity of the problem? the part number 204327. C
8.5.2q3 Can you show me a documented a) Reviewing nonconformities (including customer Yes, the procedure (Q/YCQP2026-2011).
procedure defining requirements? 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 C
e) Records of the results of action taken
f) Reviewing corrective action taken
8.5.2q4 Can you show me records of corrective Yes, and 8D report is used to identify root
actions taken? cause of problem, for example of the case
#130060 on the part number 204327. C
T8.5.2.1q1 Where is the process for problem solving Yes, the procedure (Q/YCQP2026-2011)
defined?
Does it lead to root cause identification C
and elimination? (Review records)
T8.5.2.1q2 If one or more customer requires a Yes, and 8D report is used to identify root
specific problem-solving format can you cause of problem. For example, the case
show me records documented as #130060 on the part number 204327. C
required?
T8.5.2.2q1 Can you show that error-proofing Yes. SEE PHOTO #31.
methods are used in the corrective C
action process?
T8.5.2.4q1b How long does the analysis take? The lead time has been defined as couple
Are records made available (to of weeks in the procedure (Q/YCQP2026-
customers) upon request? 2011). C
T8.5.2.4q1c Is the time consistent with the Yes, the time is sufficient.
determination of root cause, corrective
C
action and monitoring the effectiveness
of implementation?
ISO/TS 16949 QMS Audit Form Rev.
AUDIT CHECKLIST 0
C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE TO CHECK FINDINGS SCORE
8.5.3 Preventive Action
8.5.3q1 How do you determine potential PFMEA is used as mean tool to determine
nonconformities to take action one? potential nonconformities, and proposal
Do preventive action records identify and action are recorded. C
address root cause(s)?
8.5.3q2 Are actions taken appropriate to the Yes, actions are taken in consideration of
severity of the problem? the value RPN obtained from the Severity
(S), Occurrence (O) and Current Detection
Method (D). C
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
ISO / TS 16949 QMS Audit Form 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
25. Training program for special job position 26. Traing test record
29. Work instruction at assembly line 30. Work instruction at assembly line
ISO / TS 16949 QMS Audit Form Rev.
FACTORY PHOTOS 0
Supplier Name Audit Date Report No.
XXXXXXXXXXXXXXX XX/XX/XXXX XXXXXXXXX
33. A view of client's product 34. A view of packaging process for client's product
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
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