11 replies to this topic

[Markcra]

I am an experienced 3rd party auditor in both HACCP and ISO 9001. Recently I have started to audit against ISO22000, but only have one client under this standard. Last week I failed my witness audit (the overseeing accreditation body for the certification body that I work for) due to wrongly classifying a non-conformance (I raised 9 audit findings - 1 major and 8 minor). I would appreciate some opinions regarding how the following scenario could be rated eg minor or major non-conformance.

The client that I audited processes flexible packaging (printing, adding pinholes, shirring and laminating). The end product is used for casing cured meats and vacuum sealing. That is the product is food contact.

In a particular process, a machine (shirring) with a rotating knife blade is used on the plastic film. This process is identified as a CCP as there is a hazard of the knife blade breaking and becoming lodged on the film which is rolled up.

The CCP is monitored by an operator by regular visually checking for a damaged blade and there is a metal detector on the line, in the event that a broken blade enters the product. At the beginning of each shift the operator as part of the standard operating procedure checks the operation of the metal detector with a test piece.

During the audit I interviewed the operator and asked him how he monitored the CCP. He showed me how the machine is visually checked to determine if there had been any damage to the blade and how the metal detector worked when he put the test piece through. The metal detector sounded an audible alarm and the line stopped, so that the product could be isolated. I also checked with his Supervisor who verified that this check was done at the start of each shift.

The HACCP plan required the operator to record the start up operational check on a form. This was not being done. During the morning I was shown a critical incident report, where several months ago a blade did happen to break and the product was isolated and discarded. Customer complaint records show that there has never been a problem with a broken blade ending up in the finished film/product.

Given that the client had demonstrated that the monitoring process was effective in controlling the CCP, what rating would you apply to the audit finding that there were no records of the metal detector being checked at the start of each shift.

Regards

Mark

[Madam A. D-tor]

Dear Mark,

I would raise a major on 7.6.4. NC-description would be:

From records it is not demonstrable that the CCP is under control.
There are no records of measurements or observations.

All non-conformities relating to CCPs should be a major. Even if these are only theoretical. For HACCP-certification, ISO 22000 and FSSC 22000 the CCPs are the most important subject of the standard. If these do no comply with standard requirements there should be a major. If the organisation failed to show you the other evidence (interview, demonstration, critical incident report) it should have been a critical non conformity.

All above of course to my opinion.

[Charles.C]

Dear Markcra,

No documentation = it was never checked = negative detection results hv no meaning. + failure of verification system + training system ++++

I am predicting you classified it as minor.

I'm not a professional auditor but I would hv thought the assessment might also depend on things like - did the form actually exist but simply not filled in ?, other CCPs handled correctly ?, audit history, eg first deviation from a well documented correct scenario, how long the discrepancy had existed, explanation (if any) ?

In the sense of the whole HACCP system relies on documented monitoring of the CCPs, it seems like a rather non-minor thing to me but .....

Rgds / Charles.C

[mind over matter]

Hi Markcra,

What's the reason why you want to know the rating to the audit finding? If you do use major or minor, what do you expect client to do different when they address them? I am predicting it's the timetable by which they are resolved, but I'm curious and interested to hear the reason from you.

[Madam A. D-tor]

Dear Mind over Matter,

If an auditor raise a major for an initial certification audit, the organisation will not be certified, until it is proofed that the major is solved (re visit).

If there are too many majors and minors, a total new initial audit will be needed.

A major raised during a surveillance audit, needs to be followed up with an follow up audit. Minors are usually only verified during the next surveillance audit.

Above is applied for the standards ISO 9001, HACCP, ISO 22000, FSSC 22000, ISO 14001, etc.

Edited by Madam A. D-tor, 25 July 2011 - 02:53 PM.

[Markcra]

Hi Markcra,

What's the reason why you want to know the rating to the audit finding? If you do use major or minor, what do you expect client to do different when they address them? I am predicting it's the timetable by which they are resolved, but I'm curious and interested to hear the reason from you.

I needed some other opinions, as I don't audit many clients for ISO 22000. This is my first certified food safety standard and my experience is with ISO 9001 where majors are not common. So I need to re calibrate my judgement as it seems that in the certified food safety standards majors are more common in every day audits.

The minor would be followed up at the next visit in 6 months time, but the major would need to be checked in 3 months. It is a good client and from past experience they would act immediately to restore the recording of the checks.

[mind over matter]

Dear Mind over Matter,

If an auditor raise a major for an initial certification audit, the organisation will not be certified, until it is proofed that the major is solved (re visit).

If there are too many majors and minors, a total new initial audit will be needed.

A major raised during a surveillance audit, needs to be followed up with an follow up audit. Minors are usually only verified during the next surveillance audit.

Above is applied for the standards ISO 9001, HACCP, ISO 22000, FSSC 22000, ISO 14001, etc.

I completely understand your view point, and I was only refering to the process of treating both minors and majors as requiring corrective actions.
If there is a ruling, under the third party registration scheme, on categorizing nonconformities, it surely has something to do with the difference in grading of the nonconformities. But....

I would appreciate if someone could cite any references to grading nonconformities.

Edited by mind over matter, 26 July 2011 - 01:05 AM.

[Philips]

Well, I have a bit of experience in auditing food safety management system. One, you may have failed in your test if you could not be able to demonstrate the facts on the ground, however, your judgement was correct, this is a major non conformity. The issue here is, if an occurence would happen due to the failure of operator monitoring the CCP, Would it cause a negative impact to the consumer, and the answer is yes, thus a major; this is not when a document is not signed, but whe a ccp is not monitore, and the evidence of monitoring is the record maitained, your classification is okay, major with no mercy.

[Yuri]

I completely understand your view point, and I was only refering to the process of treating both minors and majors as requiring corrective actions.
If there is a ruling, under the third party registration scheme, on categorizing nonconformities, it surely has something to do with the difference in grading of the nonconformities. But....

I would appreciate if someone could cite any references to grading nonconformities.

Major nonconformity
Is one or more of the following:
• The absence or total breakdown of a system to meet a requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
• Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
• A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure control of processes and products.

Minor nonconformity
Is a failure to comply with the standard which based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products. It may be one of the following:
• A failure in some part of the client's quality management system relative to the standard
• A single observed lapse in following one item of a company's quality management system.

[Yuri]

As for the original question: this would be a major non-conformity for me: no proof of monitoring.

[mind over matter]

Major nonconformity
Is one or more of the following:
• The absence or total breakdown of a system to meet a requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
• Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
• A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure control of processes and products.

Minor nonconformity
Is a failure to comply with the standard which based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products. It may be one of the following:
• A failure in some part of the client's quality management system relative to the standard
• A single observed lapse in following one item of a company's quality management system.

Now, can you cite a reference to grading nonconformities from ISO 22000?

[Dr Ajay Shah]

If the HACCP plan indicates that the start up should be monitored and recorded and it is not then from a due diligence perspective it is not meeting the requirements and so should be classed as a Major Non conformance.