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We're here to talk about something that, when it happens, usually brings chaos: non-conformity (NC) situations. Some people take it personally, others blame the Quality team, while others, in line with the requirements of ISO 9001, act correctly. Which group do you fall into?

To support everyone who deals with these challenges on a daily basis (waste, rework, cost of non-quality and non-conformity management), we highlight the importance of two requirements of the ISO 9001:20158.7 - Control of Non-Conforming Outputs and 10.2 - Non-Conformity and Corrective Action.

Let's break it down:

1 - Recording the non-conformity, root cause analysis and action plan

A non-conformity record is the initial guideline and should be drawn up to document and :

• Identify the non-conformity and the unmet requirement,
• Analyze the root cause (the real reason why the non-conformity happened),
• Draw up an action plan with corrective actions (to eliminate an identified non-conformity), corrective actions (to address the root cause) and preventive actions (to avoid recurrence of the non-conformity).

Tips on root cause analysis

The root cause of a non-conformity is most often management problems. You should avoid “blaming” an employee for a non-conformity. Quality professionals need to have the skills and use the applicable quality tools, such as 5 whys or Ishikawa.

Some types of root cause can be: ineffective or absent communication, insufficient project requirements, changes not clearly identified, lack of experience/competence, genuine human error even with training, use of unapproved material, incorrect storage condition, lost output record, among many others.

Classification of non-compliance

In some companies, there is a classification of non-conformities according to impact, damage to the company's image, damage to property or occupational safety (similar to the risk matrix). Remember that this is not a requirement of ISO 9001, but if it is, make sure everyone understands how to apply it.

2 - It is a non-compliant output and the customer must be informed

Activities carried out to inform the customer must be described in documented information: who, how and when the communication to the customer will be carried out, in accordance with the requirements of ISO 9001: 7.4-Communication and 8.2.1 - Communication with the Customer.

Keep all the evidence at hand to include in the record of non-compliance (e.g. minutes, emails). This way, you'll have all the information traceable in an organized manner.

3 - When non-compliance occurs, it's time to put on your “systems thinking“

To support the necessary systemic thinking, we propose some reflections:

• Sand risk management if it were better executed, would it be possible to anticipate preventive actions and avoid NC?
• It is necessary to update the risks and opportunities spreadsheet after identifying this NC?
• The input data for the management's critical analysis have they been updated yet?
• If processes were efficient, would there be a NC?
• The performance indicators enough to identify the problem beforehand?
• It is possible to measure the cost of non-quality, In other words, the financial cost that the company is wasting on treating this NC?
• Has there been any lesson learned about the situation?
• It will be necessary to draw up a change management because of this NC?
• Were the corrective actions to address the NC effective, i.e. was the root cause addressed?

⭐ We know that dealing with non-conformities can be a complex challenge. How has your organization been managing these situations? What about team rework rates? I'd be interested to hear about your experiences and difficulties in this regard. Let's talk and explore solutions to these challenges together

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