IATF 16949:2016 Audit Findings Feedback!

This message is going out to companies working on implementing IATF 16949:2016 to provide you with some findings identified during an IATF 16949:2016 transition audit by a 3rd party registrar auditor. Also included is a listing of the top 10 major and minor findings identified during IATF transition audits world wide.

QSG is sharing this to give you a sense of areas that you might want to take another look at prior to your own transition audit. Feel free to reach out to us if you have any questions or need help in formulating how to deal with these items within your own system.

Specific Findings (all were minor findings):
1. The process of management of product-safety related to products and manufacturing processes is not fully documented. IATF Ref. 4.4.1.2
Obj. Evidence: No rules available to apply in different processes in case of safety products. SOP only states that rules will be applied in the future if safety products are identified (currently no safety products).
2. The system doesn’t ensure that special characteristics are correctly documented. IATF Ref. 8.3.3.3
Obj. Evidence: No clear rules defined to identify all level of special characteristics of products and product processes; a symbol is used on drawing, FMEA and control plan for some products but significance and consequences in FMEA and Cpk level is not known by all involved people. In one case, a specific characteristic was identified by a symbol on the drawing, but not in the purchasing specification and product PPAP. No conversion table is available to explain the correspondence between all symbols and notations used by difference customers.
3. The quality management system is not fully documented. IATF Ref. 7.5.1.1
Obj. Evidence: Detail and justification of product design responsibility exclusion not documented in quality manual. Process definition and interfaces are confusing. Customer specific requirements and the link between IATF requirements and orgranization’s processes not fully documented.
4. The process of competency management is not fully effective. IATF Ref. 7.2
Obj. Evidence: No evidence found to demonstrate that competences needed for each job were identified and reviewed; only the conclusion of need is included in yearly appraisal. Competences on quality tools such as 8D, FMEA, MSA, SPC are not detailed. No evidence of effectiveness review and results after training or development actions.
5. Effectiveness and efficiency of all product realization and support processes are not reviewed by top management. IATF Ref. 5.1.1.2
Obj. Evidence: No proof of efficiency evaluation found for maintenance, purchasing, product development, infrastructure, and planning processes.
6. The system doesn’t ensure that all measuring resources are fully controlled. IATF Ref. 7.1.5.1
Obj. Evidence: Scale of material feeders not calibrated; preventive maintenance checklist doesn’t request a verification and the scales are not considered as measurement devices to be calibrated.
7. The second party audit process is not sufficient to develop suppliers. IATF Ref. 8.4.2.4.1
Obj. Evidence: Only performance is defined as criteria to plan a supplier audit in SOP; quality system level is not taken into consideration. No supplier audits done in the last 12 months and no plan defined.
IATF Stakeholder Conference (9/13/17) – Top Nonconformances (in order of frequency, high to low)
Major:
  • 7.2.3 Internal Auditor Competency
  • 8.5.1.5 Total Productive Maintenance
  • 6.1.2.3 Contingency Plans
  • 10.2.1 Nonconformity and Corrective Action (ISO)
  • 6.1.2.1 Risk Analysis
  • 10.2.3 Problem Solving
  • 4.3.2 Customer Specific Requirements
  • 8.5.1 Control of Production and Service Provision (ISO)
  • 4.4.1.2 Product Safety
Minor:
  • 8.5.1.5 Total Productive Maintenance
  • 8.5.1.1 Control Plan
  • 8.5.1 Control of Production and Service Provision (ISO)
  • 6.1.2.3 Contingency Plans
  • 8.3.5.2 Manufacturing Process Design Output
  • 8.3.3.3 Special Characteristics
  • 8.5.1.2 Standardized Work – Operator Instructions and Visual Standards
  • 7.1.5.1.1 Measurement Systems Analysis
  • 8.5.1.3 Verification of Job Setups

Always Keep Improving!