OBJECTIVE OF THE CHECKLIST DOCUMENT
The objective of these checklists is to assist you in the planning, implementation, and internal auditing of your ISO/TS 16949:2002 quality management system. In particular, the checklists can be used effectively in the following three ways:
1. Establishing a Baseline and Action Plan: The checklists provide a baseline at the start of implementation to identify what needs to be done to revise or develop your quality management system to meet the ISO/TS 16949:2002 Standard.
2. Implementation Guidelines and Checks: The checklists provide a reference to measure progress and to verify that your quality management system, documentation, and practices are complete and correct as you proceed in establishing and implementing your ISO/TS 16949:2002 quality management system.
3. Internal Auditing: The checklists clearly define what to audit and how to document that your quality management system is conforming to ISO/TS 16949:2002.
Checklists help to ensure that the audit is conducted in a systematic and comprehensive manner, and the proper evidence and documentation are obtained. More specifically, comprehensive checklists guide the auditor (or audit team) in the following ways:
1. Checklists specify what elements of the quality management system need to be observed, and what levels of performance or adherence are required to satisfy the Standard.
2. Checklists specify what personnel need to be interviewed, and the types of questions or issues to address.
3. Checklists specify the relevant quality system procedures and/or work instructions that need to be evaluated for effectiveness and adherence under routine and non-routine conditions.
4. Checklists specify what evidence needs to be obtained to properly sample and document the performance and effectiveness of your quality management system.
5. Checklists assist in developing an audit schedule, and in pacing the audit to complete your objectives in the allotted time.
Checklists help you do a better job with much less effort.
NOTE
The checklists in this document are not intended to substitute for the ISO/TS 16949:2002 Standard. It is highly recommended that you purchase this standard from the Automotive Industry Action Group (AIAG), 26200 Lahser Road, Suite 200, Southfield, MI 48034, P: (248) 358-3570, F: (248) 358-3253 to supplement the checklists and to provide the baseline from which the checklists were written. Within the checklists, major excerpts from ISO/TS 16949:2002 are shown in italics to clearly identify their source.
USING STANDARD CHECKLISTS
Standard checklists can be a valuable tool to assist you in the planning, implementation, and internal auditing of your ISO/TS 16949 quality management system. Since individual companies need to interpret and “fine-tune” the implementation of the Standard to meet their individual needs and unique characteristics, standard checklists also need to be “fine-tuned”.
The CD allows you to select and modify these checklists to incorporate your specific quality policies, procedures, work instructions, and other unique characteristics, and to sample and select the checklists needed to audit “taking into consideration the status and importance of the processes and areas to be audited”. Use the CD to select and modify the checklists to best suit your needs.
DISCLAIMER
The material presented in this document is based upon the requirements of ISO/TS 16949:2002 and our experiences gained through successful application and implementation of quality management system requirements. Every organization is different, however, in terms of its needs, its culture, and its level of quality management system development. These differences may require that the generalized guidelines in this document be applied with special considerations. Readers are advised and cautioned that Steudel and Mann, LLC nor Steudel & Schultz, LLC will accept no responsibility for the way in which these guidelines are applied in an organization, or the problems which may arise, unless we are contracted to assist in the implementation and management of these activities.
STATUS CODE DEFINITIONS
N: “Nonconformance”. Indicates a nonconformance of some aspect of the Quality Management System to the ISO/TS 16949:2002 Standard. Examples include, but are not limited to, system absences and nonconformance of company employees to follow documented policies, procedures, and work instructions.
W: “Weakness”. Indicates a weakness of the Quality Management System. This means that the element under consideration may conform to the letter of the ISO/TS 16949:2002 Standard, but has the potential to fail under certain circumstances; for example, system elements which are in place but under-developed and/or misunderstood.
O: “Opportunity”. Indicates an opportunity to improve the Quality Management System, including findings which may not be specifically required by the ISO/TS 16949:2002 Standard or findings that could “pass a registrar’s audit”, but undermine the effectiveness of the Quality Management System. An example would be a finding where documentation could be streamlined or simplified to facilitate understanding or better reflect organizational practice. Another example would be an opportunity to increase the effectiveness of the Quality Management System, utilizing the approaches and guidelines provided in the ISO 9004:2000 document.
C: “Compliance”. Indicates that the Quality Management System element has been examined under the guidelines of the checklist and that no nonconformances were found. Note, however, that this does not necessarily mean that there are no nonconformances in the Quality Management System element, only that none were found under the scope of the examination.
X: “Not Applicable”. Indicates that the particular element or checklist question is not applicable to the organization or department being audited.
TABLE OF CONTENTS
NUMBER OF CHECKLIST ITEMS BY ISO/TS 16949:2002 CLAUSE/REQUIREMENT
Number of
Clause/Requirement Checklist Items Page
4 QUALITY MANAGEMENT SYSTEM 40 1
4.1 General Requirements 5 2
4.2 Documentation Requirements 35 5
5 MANAGEMENT RESPONSIBILITY 37 22
5.1 Management Commitment 2 23
5.2 Customer Focus 1 24
5.3 Quality Policy 7 25
5.4 Planning 7 28
5.5 Responsibility, Authority and Communication 10 32
5.6 Management Review 10 38
6 RESOURCE MANAGEMENT 24 44
6.1 Provision of Resources 1 45
6.2 Human Resources 14 46
6.3 Infrastructure 5 53
6.4 Work Environment 4 56
Number of
Clause/Requirement Checklist Items Page
7 PRODUCT REALIZATION 247 59
7.1 Planning of Product Realization 16 60
7.2 Customer-related Processes 21 69
7.3 Design and Development 65 80
7.4 Purchasing 27 116
7.5 Production and Service Provision 84 130
7.6 Control of Monitoring and Measuring Devices 34 172
8 MEASUREMENT, ANALYSIS & IMPROVEMENT 123 190
8.1 General 7 191
8.2 Monitoring and Measurement 52 195
8.3 Control of Nonconforming Product 24 223
8.4 Analysis of Data 8 235
8.5 Improvement 32 239
Total Checklist Items 471
8.2 MONITORING AND MEASUREMENT8.2 MONITORING AND MEASUREMENT
QMS CHECKLIST QUESTION
(ISO/TS 16949 REQUIREMENT)AUDITING GUIDELINES
/REMARKS & EVIDENCE
/STATUS
**- Does the organization have a documented procedure for identifying and controlling nonconforming, unidentified and suspect product to prevent its unintended use or delivery?
Ensure this documented procedure exists and verify it addresses the controls and related responsibilities and authorities for dealing with nonconforming, unidentified and suspect product.
- Are criteria defined to specify under what circumstances the procedure for control of nonconforming product is to be initiated, and when the operator can simply perform the necessary activities to make the material conform to the specified requirements?
Review the procedure and verify that people agree when material is nonconforming versus in-process.
QMS CHECKLIST QUESTION
(ISO/TS 16949 REQUIREMENT)AUDITING GUIDELINES
/REMARKS & EVIDENCE
/STATUS
**- Is nonconforming, unidentified and suspect product being reported correctly?
Review a random sample of nonconforming material reports and state the results.
- Are all relevant personnel aware of a “Stop Order” (or some equivalent means) to stop production on a given order when quality problems are identified?
Interview personnel on this issue and verify that the method used is effective in preventing further processing.
QMS CHECKLIST QUESTION
(ISO/TS 16949 REQUIREMENT)AUDITING GUIDELINES
/REMARKS & EVIDENCE
/STATUS
**- Is nonconforming, unidentified and suspect material properly identified with a “Do Not Use” tag (or equivalent) and/or does the organization have clearly identified “Bond Areas” to prevent inadvertent use of this material?
Interview personnel on this issue and review nonconforming, unidentified and suspect material for suitable identification and segregation.
- Does the procedure for control of nonconforming product provide for notifying affected personnel of nonconformities to prevent disruptions in production schedules and customer deliveries?
Review the procedure, trace a sample of recent nonconforming material incidents to verify, and state the evidence.
QMS CHECKLIST QUESTION
(ISO/TS 16949 REQUIREMENT)AUDITING GUIDELINES
/REMARKS & EVIDENCE
/STATUS
**- Does the procedure for control of nonconforming, unidentified and suspect product address the responsibilities and steps to follow in order to identify and assemble personnel with appropriate knowledge, responsibility, and authority to determine the products’ disposition?
Review the procedure and state the evidence.
Note that nonconforming product can be dealt with by taking action to eliminate the detected nonconformity (rework); by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer (use as-is or repair); or by taking action to preclude its original intended use or application (scrap or regrade).
- Are records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, maintained?
State the evidence based on a random sample of nonconforming material reports. Also comment on how the information in these records is utilized for data analysis and ongoing improvement efforts (see Clause 8.4).
QMS CHECKLIST QUESTION
(ISO/TS 16949 REQUIREMENT)AUDITING GUIDELINES
/REMARKS & EVIDENCE
/STATUS
**- Is there evidence to suggest that the review and disposition of nonconforming product are not being completed in a timely manner?
Review a sample of nonconforming material reports and also assess bond or hold areas to determine the amount of time materials have been staged there.
- Are all nonconforming products that are reworked or repaired then reinspected to demonstrate conformity?
Review a sample of nonconforming material reports and verify that any required re-inspections have been performed and recorded.
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