Investigating Non-Conformances

As a food auditor an important part of the job is identifying non-conformances during the audit process. Unfortunately, many food businesses struggle with what is required to rectify non-conformances. Any non-conformance identified during an external or internal audit should be seen as an opportunity to really get in and resolve an issue before it escalates to a point where significant damage can occur to the business.

After an issue or non-conformance has been identified the business should not only seek to rectify the issue immediately but to also investigate the root cause of the problem. This means really finding out why the problem occurred in the first place. There are plenty of different models out there for investigating the cause of non-conformances including Brainstorming, Root cause analysis, The 5 Whys and Cause & Effect Diagrams.

I really like the 5 Whys model as it reminds me of my kids when they constantly question why they are not allowed to do something.

The following example shows how the method can be used in a food manufacturing business:

Non-conformance: No paper towel at wash hand basin

Q: Why is there no paper towel supplied to the wash hand basin?

A: Cleaner did not refill

Q: Why did the cleaner not refill?

A: Could not locate any stock

Q: Why was there no stock?

A: Stock had not been ordered

Q: Why had the stock not been ordered?

A: The purchasing officer was not informed that stock was low.

Q: Why were purchasing not informed?

A: The cleaner didn’t know who to tell.

Q: Why didn’t the cleaner know who to tell?

A: They have not been adequately trained in the procedure

As you can see, your questions may not always be limited to “5 Whys” – it could be more or it could be less. The band-aid solution in this case would be to just refill the paper towel dispenser.

Does your business apply the “band-aid” to non conformances or investigate the root cause? If you continually receive the same types of customer complaints or the same issues are being identified for example at each GMP audit that you do, you are most likely not doing anything or just using a band-aid solution.

I challenge you to now have a look at your last GMP inspection that you did and see if:

(1) All the issues that you identified have been rectified

(2) The root cause has been investigated and documented

(3) Suitable controls have been put into place to prevent a re-occurrence of the non-conformance.

For more information on any of the models used to investigate non-conformances just do a search using your internet search tool.

Want to learn more about investigating and rectifying non-conformances? Show your interest by contacting us or leaving a comment.

15 thoughts on “Investigating Non-Conformances”

  1. I have one question. If a food safety team leader complains that one auditor has raised 15 minor non conformities during the first day audit. and many of them are very minor NCs. as team leader what is his actions against this situation.? please describe.

    1. Amanda Evans-Lara

      I would suggest that you consult with the auditor as they may well be correct. The auditor will be able to explain the evidence reviewed and what part of the audit criteria was not met. If you are still unsatisfied, you can approach your certification body for a review. Please also keep in mind that all of the major GFSI recognised standards allow for minor non-conformances. You can review the audit protocol documented as part of your audit standard to find out the definition of a ‘minor’ non-conformance.

    1. It really depends on the risk to the finished product and also the standard that you being audited against. As a general rule it will be practices that can lead to a consumer becoming sick or injured from your food. Examples can include not washing hands, food handler working with infectious disease, holding food at the incorrect temperature, cross-contamination, allergen cross-contact, pest infestation etc

  2. Amazing article and explanation!

    Amanda, i have some queries regarding general perception;

    1. what would be the evidence required for food industry that use pipes for transfer of raw and value adding materials?
    2. what main thing should be verified in the evidence of food grade material?
    3. if any cloth is used for packing of finished product, then food grade evidence will be even required of material?
    4. Any specific coating material for walls and ceilings so that no long term impact on food and prevent from rainy environment?

    Thank you!

  3. Hi, I am Jagdeep.
    It’s an excellent article for managing non-conformances. Use of Why-Why analyses tool makes it interesting & easy for the users to arrive at corrective actions.
    We can further divide the corrective actions in two parts e.g. immediate corrective measures to fix the problem and proposed corrective actions to avoid recurrence of the same problem.
    Another aspect may be to include cost of(due) to non-conformances which can help getting the required support from all stake-holders.

    1. The number of non-conformances that can be raised is generally restricted to the requirements of the standard to which you are being audited against.

  4. Articolo molto interressate! Anche io mi occupo di problematiche simili come la consulenza e formazione nel settore alimentare.

  5. Amanda,
    I have not received any clear non conformaties examples and corrective action yet for food industry.
    Kindly elaborate.
    regards daniel

    1. Hi Daniel

      The type of non conformances that you get will be dependent on the standard that you get audited against. Some examples of non conformances that I would raise in an external audit include CCP monitoring records not available, staff observed not washing their hands, micro testing not completed on finished product, the HACCP flow process chart has not been verified, unclean mixing equipment. I give give hundreds of examples but the best way is to look at what your audit standard says that you have to do. If you are not doing as required, that is considered to be a non-conformance.

  6. Good analysis. Need to know more on Non-conformaties. The evidences and requirements as per ISO 22000 ,with more examples and observations during various food industry audits.
    Daniel
    Delhi
    India
    9810590278

    1. Hi Daniel, thanks for your comment. I will look at providing more information on how to evidence non-conformances int he coming weeks. Until then, the majority of standards require (ISO22000 included) that any non-conformances you find in your business are rectified so they don’t happen again. As part of this process, you need to undertake a root cause analysis to determine why the issue happened in the first place. What type of examples are you after? Examples of the non-conformances that I see and raise as an external auditor, or issues that are being recorded by the food business as part of their system? Just let me know, and I will go from your lead.

      Regards…..Amanda

  7. Hi everybody,

    I am Mahmoud, i really enjoyed this topic and i would like to master the root cause analysis could you send me more details, websites to visit or maybe a training course related to this subject.

    Thanks again.
    Mahmoud

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