IATF16949:2016 Transition Audit: Document Review

Document Review conducted:1 / Off-site On-site, after failed off-site review
Client: / AZ/Ref:
Address:
DQS Auditor Evaluation
Requirement / Acceptable / Concern / Not acceptable
1. Quality Manual
The Quality Manual complies with the requirements of 7.5.1.1 IATF16949? / 7.5.1.1
-Defined scope of the QMS, definition of organizational structure & boundariesand justification for any exclusions and details about infrastructure, different sites/locations, products, services, processes and activities including supporting functions (whether on-site or remote) and externally provided/outsourced functions.
-Documented processes established for the QMS, or reference to them.
-The organization’s processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes.
-There is a clearly defined linkage and relationship into support functions (on-site or remote) &/or outsourced processes.
-A document (i.e. matrix) indicating where within the organization’s QMS their CSR’s are addressed.
Evidences of evaluation and/or comments /actions required:
2. Design responsibility
Clear description and detailed evidence of design responsibility? / 4.3.1; 8.3
-Design responsibility or non-design responsibility clear and sufficiently detailed and justified (organization or client?)?
-Evidence that the organization and/or subcontractorshave the appropriate capability to meet IATF 16949, clause 8.3 requirements?
Evidences of evaluation and/or comments /actions required:
3. Context of the organization
Evidence that the organization has reviewed, considered andapplied the requirements regarding the context of the organization?
-Including identification / definition of relevant internal/external interested parties and associated needs/expectations, customer-specific requirements and risks & opportunities (with clear justification for parties excluded).
Evidences of evaluation and/or comments /actions required: / 4.1
4.2
4.3.1, 4.3.2
4. The QMS
Sufficient documented information to showthe QMS (includingprocesses & interactions) meets the requirements of IATF16949 + ISO9001:2015and processes &/orprocedures show complianceto IATF16949 requirements?
-Processes are defined to a level that meets with the context of the organization(links, interfaces, input/outputs, external & supporting, outsourced processes included), processes support risk based thinking to cover the scope of the organization and its QMS?
-Objectives & targets defined and monitored to confirm effective implementation of the processes encompassing the organization’sQMS with defined measurable links to relevant internal/external factors (incl.legal /Regulatory) aligned to strategic goals?
-Resource needs (personnel, infrastructure, equipment, skills, etc..) are clear and process ownership, responsibilities and authorities are defined?
Evidences of evaluation and/or comments /actions required: / 4.4
5. Quality & Corporate responsibility
Quality & Corporate responsibility policies have been reviewed, aligned, implemented and communicated (with ownership defined and fulfilling the requirements of ISO9001:2015+IATF16949, e.g. appropriate to purpose/context, framework for setting quality objectives, commitment to satisfy applicable requirements and to continual improvement);
-Defined and implemented corporate responsibility policies, including as minimum:anti-bribery policy, employee code of conduct, & an ethics escalation policy ("whistle-blowing policy").
.
-Quality Policy is available to relevant interested parties?
Evidences of evaluation and/or comments /actions required: / 5.1
5.2
DQS Auditor Evaluation
6. Required documented processes or documentation requirements of IATF 16949 (additional to ISO/TS 16949) / / Requirement / Acceptable / Concern / Not acceptable /
Are documented processes / documented information in place for…?
-Product safety
Evidences of evaluation and/or comments /actions required: / 4.4.1.2
-Employee motivation and empowerment
Evidences of evaluation and/or comments /actions required: / 7.3.2
-Engineering specifications
Evidences of evaluation and/or comments /actions required: / 7.5.3.2.2
-Supplier selection process
Evidences of evaluation and/or comments /actions required: / 8.4.1.2
-Type and extent of control on outsourced processes
Evidences of evaluation and/or comments /actions required: / 8.4.2.1
-Supplier monitoring
Evidences of evaluation and/or comments /actions required: / 8.4.2.4
-Total productive maintenance
Evidences of evaluation and/or comments /actions required: / 8.5.1.5
-Control to changes that affect product realization
Evidences of evaluation and/or comments /actions required: / 8.5.6.1
-Control of reworked product
Evidences of evaluation and/or comments /actions required: / 8.7.1.4
-Control of repaired product
Evidences of evaluation and/or comments/actions required: / 8.7.1.5
-Problem solving
Evidences of evaluation and/or comments /actions required: / 10.2.3
-Error-proofing
Evidences of evaluation and/or comments /actions required: / 10.2.4
-Continual improvement
Evidences of evaluation and/or comments /actions required:
: / 10.3.1
DQS Auditor Evaluation
7. Records / Requirement / Acceptable / Concern / Not acceptable
Documented evidence of risk analysis results
Evidences of evaluation and/or comments /actions required: / 6.1.2.1
Complete management review (MR) to IATF16949 (or a combination of previous MR to ISO/TS 16949 with supplemental MR in compliance with the additional requirements of IATF16949).
Evidences of evaluation and/or comments /actions required: / 9.3.1, 9.3.2, 9.3.3
Defined top level quality objectives in line with requirements from clients and other interested parties.
Evidences of evaluation and/or comments /actions required: / 6.2.2.1
One full cycle of internal systemaudits including (if applicable) evidence of implemented and effective corrective actions to confirm conformity with IATF 16949?
Note: For Transition, previous system audits according to ISO/TS 16949 can be used, with supplemental audits against IATF16949 to cover the gaps/ new requirements.
Evidences of evaluation and/or comments /actions required: / 9.2.2.1
List of qualified internal auditors and training evidences for IATF16949. Criteria for and competency of internal auditors & the training personnel are clearly defined and applied in a systematic way to meet requirements of IATF16949including CSRs? (System, Process, Product auditors).
Evidences of evaluation and/or comments /actions required: / 7.2.3
7.2.4
Internal audit plan fulfilling the requirements of IATF16949, includingprioritization based upon risk, performance and criticality of the processes.
Evidences of evaluation and/or comments /actions required: / 9.2.2.1
8.Supporting functions (on site or remote) - complete only if applicable
All supporting functions on site or remote have been included in the Organization’s IATF16949 transition process (including internal system audit to IATF16949) and planned arrangements meet with IATF Transition Strategy
- Certificates or copy of gap analysis covering all relevant RL’s
- Up to date action plans showing timing, responsibilities assigned and
implementation status for all relevant RL’s.
.
Evidences of evaluation and/or comments /actions required: / IATF transition strategy / Not applicable
9.Automotive product related software or automotive products with embedded software
- complete only if applicable
Evidence that suppliers of automotive product related software or automotive products with embedded software are required to implement and to maintain a process for software quality assurance for their products and to retain documented information of a software development capability self-assessment.
Evidences of evaluation and/or comments /actions required: / 8.4.2.3.1 / Not applicable
Conclusion of the document review
  1. From the information and evidence analyzed during this document review it has been demonstrated that the organization has understood and implemented the additional requirements of IATF16949 along with fulfilling the foundation requirements of ISO9001:2015. The relevant system changes have been implemented to fulfil the requirements of transition to IATF 16949.
The transition audit can be carried out as planned.
  1. From the information and evidence analyzed during this document review, the results indicate there are open points of minor concern, which require immediate action and resolution prior to conducting the transition audit to IATF 16949.
The indicated changes (see the associated section of this document) are minor in consequence and do not pose direct risk to possible timelines for transition audit. The transition audit can be carried out as planned, provided that evidences of implemented corrective action are sent to the lead auditor prior to the prior to the transition audit
  1. The information and evidence analyzed during this document review, show significant gaps between the organization’s QMS and the requirements of IATF16949 and/or ISO9001:2015. It is deemed that the Organization is not ready for transition to the new standard.
Actions (see the associated sections of this document) require completion to demonstrate compliance before the transition Audit can be planned.
0.5 mandays at a minimum is to be added to the start of the audit in order to review the correction of open points and to collect and review missing audit planning information (IATF 5th 5.7),
Auditor additional comments, notes, agreed actions,next steps:
Lead auditor / Date / Signature

Confirmation of receipt / Empfangsbestätigung

Client / Date / Signature

*Signing applicable for On-Site Document Review, confirmation via email, customer /stamp acceptable for Off-site.

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