Top 10 IATF 16949 Minor Nonconformances
SimpleQuE’s infographic shows the top 10 IATF 16949 minor nonconformances as reported by all IATF Certification Bodies from January – October 2019.
A majority of the minor nonconformances fall under the Operations section with clauses 8.5.1 Control of Production and Service Provision and 220.127.116.11 Control Plan in the top three. Here is a summary of those clauses so you can be sure there are no gaps in your controls. (Refer to the IATF 16949:2016 Automotive Quality Management System Standard and ISO 9001:2015 Quality Management Systems – Requirements for full clauses.)
8.5.1 Control of production and service provision (ISO 9001:2015)
Conduct or implement production/service using controlled conditions, which shall include (as applicable):
- documentation that defines product characteristics, services to be provided, or activities to be performed and records of the results achieved
- adequate monitoring and measuring resources
- conducting of monitoring and measurement activities at appropriate states to verify process control and product/service acceptance
- suitable environment and infrastructure
- assigning competent personnel, and any required qualifications
- validations of production processes when you can’t measure the product for compliance (welding, heat treatment, plating, and other “special processes”)
- implement mistake-proofing to prevent human-error
- implement activities for release, delivery and post-delivery
18.104.22.168 Control plan (IATF 16949:2016)
Develop control plans at the system, subsystem, component, and/or material level for the manufacturing site and all product supplied, including bulk materials as well as parts.
Control plans must include:
- controls used for process control, including verification of job set-ups
- first-off/last-off part validation, as applicable
- monitoring of special characteristics
- customer required information, if any
- reaction plan when there’s nonconforming product, or the process becomes statistically unstable
Review and update when: nonconforming product is shipped, any changes occur, after customer complaint and subsequent corrective action, at a set frequency based on risk. And obtain customer approval after review or revision of control plans when required by the customer.
If you’re not sure your system is up-to-speed, simpleQuE offers certification readiness audits that are performed prior to a surveillance or initial Certification Body (CB) audit to be sure that your quality management system and team are ready. In addition, 2nd party internal audits can be conducted by our experts to be sure your system is maintained to these standards. Contact us for information about our services and on-site customized training classes for Root Cause Analysis and Problem Solving, Process Ownership, Core Tools and more.
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