IATF 16949® Top 10 Major and Minor Nonconformances in 2022

simpleQuE infographic showing the IATF 16949 major and minor nonconformances in 2022

Top 10 Major and Minor IATF 16949® Audit Nonconformances in 2022

This simpleQuE infographic shows the top 10 IATF 16949® major and minor nonconformances as reported by all IATF® Certification Bodies from January – August 2022.  As in previous years, Problem Solving and Corrective Action, which are foundational elements of any quality management system (QMS), are at the top of the Major Nonconformances chart.  This indicates organizations still struggle to maintain a disciplined corrective action and problem-solving process. The top 3 major nonconformance categories have remained consistent over the last few years, but Contingency Plans has risen to #4 from #10. Customer-specific requirements is new to the top 10 Majors in 2022.

10.2.3   

Problem solving

1,062

10.2.1   

Nonconformity and corrective action (ISO)

858

8.3.5.2   

Manufacturing process design output

441

6.1.2.3   

Contingency plans

366

7.1.5.1.1  

Measurement systems analysis

348

8.5.1.1   

Control plan

334

4.3.2

Customer-specific requirements

306

9.1.2.1   

Customer satisfaction

304

9.1.1.1   

Monitoring and measurement of processes

291

8.5.1  

Control of production and service provision (ISO)

283

   

What Is A Major Nonconformity?

A major nonconformity occurs when there is a failure to meet a requirement as indicated by one or more of the following:

  • A significant nonconformity against the requirements of the ISO 9001 and/or IATF 16949® standard
  • A failure of a complete system
  • A significant quantity of minor nonconformities
  • The lack of existence of a standard or contract requirement
  • The absence or total breakdown of a system to meet a management system requirement
  • Any nonconformity that can result in the probable shipment of nonconforming products
  • A non-compliance that is likely to result in the failure of the QMS or to materially reduce its ability to ensure controlled processes and products

What to do when there is a Nonconformity

Clause 10.2 Nonconformity and Corrective Action addresses what should take place when a nonconformity occurs.  The company should take the following steps:

  1. React to the nonconformity and take appropriate action to control the situation
  2. Correct it and handle the consequences
  3. Review the nonconformity and determine the scope and the cause with a thorough Root Cause Analysis
  4. Develop a solution and implement action plans
  5. Review actions for effectiveness – does the solution fully address the nonconformity
  6. Revise procedures as appropriate
  7. Assess risk associated with any changes

Note that Documented Information needs to be retained.

Unfortunately, some companies don’t follow through on all of these steps so corrective actions are not tracked to completion or in a timely manner. All nonconformities must be closed in 90 days. 

IATF 16949® has the additional requirements of 10.2.3 – 10.2.6 which expand upon Clause 10.2.  The organization will:

  1. Have a documented process for problem solving
  2. Have a documented process to determine appropriate error-proofing methodologies with methods documented.
  3. Implement a warranty management process including warranty part analysis – if required
  4. Perform analysis on customer complaints and returns
  5. Communicate results internally and to the customer

To address the top issues that trouble automotive suppliers, read our blog Top IATF 16949® Audit Findings and How to Address Them in the QMS. SimpleQuE’s IATF 16949® experts have also created a free video series, IATF 16949® Audits – The Good, Bad & Ugly, for automotive suppliers who struggle with audit nonconformities. The twelve videos address the problem areas and share best practices to utilize, and critical areas to avoid, from the perspective of a Certification Body auditor.  

 

 

IATF 16949® Top 10 Minor Nonconformances – 2022

SimpleQuE’s infographic also shows the top 10 IATF 16949® minor nonconformances as reported by all IATF® Certification Bodies through August 2022. Note that while these categories remain consistently in the top 10 Minors.  Contingency plans rose to #1 from #5. As in past years, a majority of the minor findings fall under the Operations section with clauses 8.5.1.1 Control Plan, 8.3.5.2 Manufacturing process design output, and 8.5.1.5 Total productive maintenance at the top.  If your QMS (quality management system) is weak in those areas, review these 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.) 

6.1.2.3   

Contingency plans

9,810

8.5.1.1

Control plan

7,963

8.3.5.2

Manufacturing process design output

7,651

8.5.1.5   

Total productive maintenance

7,046

10.2.3  

Problem-solving

6,905

8.3.3.3   

Special characteristics

6,190

7.1.5.1.1   

Measurement systems analysis

6,014

8.5.1.2   

Standardized work

5,707

8.5.1.3   

Verification of job setups

5,648

8.5.1   

Control of production and service provision (ISO)

5,301

What Is A Minor Nonconformity?

A minor nonconformity is considered a failure to comply with IATF 16949® (based on judgment and experience), which is not likely to result in the failure of the QMS or to reduce its ability to ensure controlled processes or products.

A nonconformity occurs when there is a failure to meet a requirement as indicated by one or more of the following:

  • A customer
  • The ISO 9001 and/or IATF 16949® standard
  • A statutory or regulatory body
  • Your company

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If you’re not sure your system is up-to-speed, SimpleQuE offers support during and/or after the Certification Audit to provide the most effective and efficient method of establishing corrective actions for findings identified during the audit. We work with your team to assure root cause analysis and corrective action implementation to successfully close findings to obtain certification. Contact our IATF® consultants today for information about our services and on-site customized training classes for Root Cause Analysis and Problem SolvingProcess OwnershipCore Tools and more.

SimpleQuE is not associated with the IATF®, IAOB, ANAB®, IAQG®, and is not a certification body. SimpleQuE is an independent consulting, training, and second-party auditing service provider that assists a company on a path for the company to obtain and maintain certification through accredited certification bodies.

 

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