How To Successfully Avoid and Handle Nonconformances

What is a Nonconformance?
ISO 9000 defines it as the non-fulfillment of a requirement.

When an organisation is subject to an audit, it is this ‘monster’ that must be avoided at any cost. A nonconformance is often interpreted as somebody not doing their work properly. It is also seen as a sign of failure and becomes a nightmare for business owners, for those in charge of resolving the nonconformances, and for those working in the affected areas.

This article will provide you with a detailed guide on how to successfully handle nonconformances and how to improve the corrective action process to ensure that these issues do not reoccur.

Among several sources, nonconformances are mainly generated because:

• The requirements are not known or aren’t interpreted correctly
• There is insufficient knowledge about the possible sources of these requirements (i.e. Applicable Standard, Customer, Regulatory Bodies and our own organisation)
• Implementation and/or maintenance is not done in an effective way
• Existent issues are inadequately addressed (ineffective Corrective Action and/or Problem-Solving processes)

In the latest publication from November 2022, International Automotive Task Force (IATF) statistics revealed the most common major and minor nonconformances that were found by auditors globally in the last 12 months.

Images Source: https://www.iatfglobaloversight.org/statistics/

The highest cases of Major nonconformance with IATF 16949 were “problem solving” and “nonconformity and corrective action (ISO 9001)”.

These figures include minor nonconformances that were escalated to a major nonconformance from the previous year. This is because the IATF 16949 rule 5th section states that in cases where corrective actions plan for a minor nonconformity are not implemented effectively, a new major nonconformity shall be issued against the corrective action process and the previous minor nonconformity reissued as a major nonconformity.

Manufacturers need to avoid being issued a major nonconformance because this results in the automatic suspension of an organisation’s IATF 16949 certification, which in turn is seen as a big risk factor for customers and their future business.

So, it’s critical to address minor nonconformances with urgency.

An effective problem-solving process must be in place so that the root cause can be determined and evaluated. Where there is a risk of the nonconformance reoccurring, the cause must be eliminated. And lastly, corrective actions must be implemented to avoid recurrence.

To have successful audits, organisations need to document the entire problem-solving process, from each step to the actions taken to reduce errors. This supplementary documentation is required to be compliant with IATF 16949, specifically for evidence of corrective action.

The documented process should detail:

1. Clear methods for different types and magnitudes of problems
2. Temporary measures for containing and controlling the nonconformity
3. Root cause analysis, including its methods, analysis and results
4. Systematic corrective action, including how it was implemented, and which assessments and considerations were made regarding the impact of these actions on other products and processes
5. Validation of the effectiveness of corrective actions
6. Assessment and revision of documentation

This structured approach to problem solving ensures that root cause analysis is successful. When manufacturers do not take the necessary time required to understand and evaluate the problem, they tend to resolve its symptoms and not the root cause. This leads to the same issues reoccurring because the solution was never effective.

This is why proper corrective action is fundamental, because it allows the organisation to begin to focus on being proactive in its problem-solving efforts. The aim is to improve processes instead of reacting to complaints and breakdowns.

To meet IATF goals, organisations should focus their efforts on enhancing their problem-solving capabilities. Ultimately, the aim is to continually gain more experience from each corrective action to predict failures before they occur.

However, management have a huge role to play in embedding this mindset within the daily actions and culture of the organisation. Not only do employees need the knowledge and skillset required to address issues effectively, but they also need time to focus their efforts on problem-solving.

By completing training courses, people feel empowered with best-practice skills and invaluable expertise which, in turn, provides great value to the entire organisation. When delivered using a practical approach, training can equip individuals and teams with the tools and procedures needed to monitor process behaviour, discover issues in internal systems, and find solutions for production issues.

Target your problems and resolve nonconformances with these online courses and core skills workshops:

• Problem Solving and Analysis Methods G8D/TOPS (View Course Outline)
• Failure Mode and Effects Analysis (View Course Outline)
• Measurement System Analysis (View Course Outline)
  
• Identification of Statistical Tools (View Course Outline)
  
• Control Plans (View Course Outline)
• Other Core Tools like Advanced Product Quality Planning APQP; Production Part Approval Process PPAP (View Course Outline); and more

These courses provide the most effective methods, techniques and guidelines to use when planning, documenting and conducting problem solving activities.

In collaboration with Haldan Consulting, these courses are conducted by a world-class Master Lean Six Sigma Black Belt, with more than 20 years’ experience in Business Improvement Consulting.

Find out more about these and many other training courses that are available onsite, remotely, online or through workshops/webinars.