How to Handle Process & Products Nonconformities

ISO 9001:2015 Clause 8.7.1 requires that organizations ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery, and take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This article is aimed at outlining, differentiating and stating best practices in implementing the following as a way of implementing the requirements of the standard.

• Containment,
• Corrections,
• Corrective Actions and,
• Preventive Actions.

Corrections, corrective actions and preventive actions are usually mistaken for one another and even experienced and knowledgeable quality experts do sometimes miss these up when under stress induced by a recently discovered non-conformance. There is also confusion or a misunderstanding about containment, another action taken to address non-conformances. 

This article breaks down these concepts in a step-wise manner, exploring the proper actions to address them with application throughout the quality system.

Click Here to Download Readymade Editable Toolkits & Templates on Quality Assurance/Quality Control, Lean Six Sigma, Lean Manufacturing, Six Sigma, ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HSSE, Project Management etc.

• Containment and Root Cause Investigation

When a non-conformance is identified, two things should be done immediately:

• Containment and,
• Initiation of root cause investigation.

Containment refers to an immediate action to prevent further use or distribution of non-conforming material. It involves identifying the status of all affected material and quarantining the non-conforming material within the system to prevent further. 

The goal of root cause investigation is to determine the actual cause of the non-conformance. An effective root cause investigation which needs to begin promptly upon identification of a non-conformance also helps to reveal an expanded scope of a problem and thus helping to identify other affected product that may need to be contained or otherwise acted upon.

The following methods can be used to assess root cause of a nonconforming product:

• fishbone diagram,
• flowcharts,
• brainstorming,
• or the five why’s

The amount of time required for an effective root cause investigation depends of the nature of defects, complexity of the process and level of process understanding time.

Click Here to Download Readymade Editable Toolkits & Templates on Quality Assurance/Quality Control, Lean Six Sigma, Lean Manufacturing, Six Sigma, ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HSSE, Project Management etc.

• Correction

Correction is the action taken to immediately correct the non-conformance. It is different from corrective action, as correction simply corrects the non-conformance at hand without addressing the root cause of the problem. 

Example of corrections includes reworking, recalling, rejecting, or other actions to address affected product. While correcting the problem in the field is good, implementing a corrective action to prevent a future recurrence of the non-conformance is a must.

• Corrective Action

Corrective action refers to the action taken to eliminate the root cause of nonconformities. An effective corrective action is dependent on the effectiveness of root cause investigation conducted on the non-conformities. A root cause analysis should probe into the sequence and interaction of events that resulted to the non-conformity.

• Preventive Action

Preventive action on the other hand, refers to the action taken to eliminate the cause of potential nonconformities. It differs from corrective action in that no non-conforming event has occurred yet but the possibility of it occurring has been identified. 

A proactive practice of implementing a preventive action is using a past non-conformance as an opportunity to identify possible future non-conformances.  

Performing the following assists in detecting opportunities for potential non-conformances and taking appropriate actions:

• Internal Audits: This helps to reveal areas of improvement that can lead to non-conformance. While conducting an internal audit, you should find out if there are potential causes of non-conformances even when one has not yet occurred.
• Complaint Investigations: The result of a complaint investigation may be positive, by indicating no non-conformances. However, you should find out if the investigation reveals an opportunity for a non-conformance.
• Product or Process Monitoring and Measurement: In this, you should pay attention to data that suggest a “tilt” that may result in out-of-specification product if not placed in control.
• Training Effectiveness: When verifying the effectiveness of training activities, you should find out if there is evidence that a procedure or process may be prone to error.

Click Here to Download Readymade Editable Toolkits & Templates on Quality Assurance/Quality Control, Lean Six Sigma, Lean Manufacturing, Six Sigma, ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HSSE, Project Management etc.

About the Author

Adebayo is a thought leader in continuous process improvement and manufacturing excellence. He is a Certified Six Sigma Master Black Belt (CSSMBB) Professional and Management Systems Lead Auditor (ISO 9001, 45001, ISO 22000/FSSC 22000 etc.) with strong experience leading various continuous improvement initiative in top manufacturing organizations. 

You can reach him here.