10 replies to this topic

[tnguyen1300]

During our SQF initial certification, we had a minor NC regarding Clothing and Personal Effects where our GMP Policy did not have any mentions of use and handling of disposable gloves. My corrective action is to revise the policy to include gloves but I am having difficulty identifying the root cause. I am using the 5 Whys method but I don’t think stating that I simply overlooked and forgot to include gloves in the GMP Policy would be an accepted root cause. 

 

Any help would be appreciated!! 

[Tony-C]

Hi tnguyen1300,

 

I believe your investigation, root cause analysis and response needs to go deeper.

 

For example:

 

Why wasn’t the omission picked up on Pre-assessment? (if you did one)

Why wasn’t the omission picked up on Internal Audits?

Why wasn’t the omission picked up on Document Review?

 

I wouldn’t get too hung up on root cause, I think at this stage corrections and corrective actions are more important.

 

Kind regards,

 

Tony

[#1Cookie]

I have used "SQF practitioner missed this requirement" on our NC report with no issues.

[Scotty_SQF]

I believe I have used that a requirement/guideline was overlooked as a root cause for an initial audit as well and it was approved.

[Scampi]

I think given this was your intial i.e. first SQF audit, an oversight is a reasonable root cause

[tnguyen1300]

I understand that my root cause needs to go deeper than my oversight on the gloves requirement which is why I am having trouble identifying the root cause beyond that. We did have an SQF consultant perform our internal audit and document review for us and he did not catch it either. 

 

I will try to just put what you all have mentioned and hope it gets approved! Thank you everyone for your input!

[jfrey123]

I don't think there's any need to be overly clever in this root cause.  "The person developing this program made an error and overlooked describing glove use in procedure" is accurate and truthful as the root cause.  Going on to describe how the error was never found will be the more valuable part of your root cause analysis, as Tony pointed out above, because it helps reveal where your own program wasn't strong enough to catch the omission.

 

If you haven't already, you can consider developing a program internally to review parts of the entire SQF code throughout the year (break the whole code into chunks to be checked quarterly, for example), checking your company's programs against the code, to ensure programs don't omit requirements in the future.  Include the development of such a program into your response, and it'll show you're strengthening your program as a whole.

[SQFconsultant]

Rrally don't need to go deep here.

I simply said - I must have had a brain snap while reviewingbthe other 7000 requirements and missed just 1.

Auditor acvepted that because it was truth - he chuckled too about the 7000.

[TylerJones]

Hi all,

 

I'd go the same route as mentioned above and write it as an oversight, but with 1 slight change. All the years I have done these types of audits a root cause could not be a single person. If doing a 5 why or similar and root cause was a specific infividual I'd go back up a step and ask the question again. These food safety policies / schemes are designed to be a team effort, I'd simply say it was oversight by the food safety team when creating the document. It also shows your fellow assosciates including upper management that this is a team effort and being the first audit it would be a great way to emphasize that. 

Great job on your audit if thats all they found!

[cpgroupinc]

I don't think there's any need to be overly clever in this root cause.  "The person developing this program made an error and overlooked describing glove use in procedure" is accurate and truthful as the root cause.  Going on to describe how the error was never found will be the more valuable part of your root cause analysis, as Tony pointed out above, because it helps reveal where your own program wasn't strong enough to catch the omission.

 

If you haven't already, you can consider developing a program internally to review parts of the entire SQF code throughout the year (break the whole code into chunks to be checked quarterly, for example), checking your company's programs against the code, to ensure programs don't omit requirements in the future.  Include the development of such a program into your response, and it'll show you're strengthening your program as a whole.

If you haven't already, you can consider developing a program internally to review parts of the entire SQF code throughout the year (break the whole code into chunks to be checked quarterly, for example), checking your company's programs against the code, to ensure programs don't omit requirements in the future.  Include the development of such a program into your response, and it'll show you're strengthening your program as a whole. 

 

This is the Internal audit for their program. "Gloves" have been missed by the SQF practitioner and by their consultant, who performed the internal audit as well.

[Charles.C]

During our SQF initial certification, we had a minor NC regarding Clothing and Personal Effects where our GMP Policy did not have any mentions of use and handling of disposable gloves. My corrective action is to revise the policy to include gloves but I am having difficulty identifying the root cause. I am using the 5 Whys method but I don’t think stating that I simply overlooked and forgot to include gloves in the GMP Policy would be an accepted root cause. 

 

Any help would be appreciated!! 

Hi tnguyen,

 

The previous deep analyses are relevant but if you are in desperation the quickest (ultimate) RC solution is "Training" which despite some auditors opinions/disparagement (eg too generic) can be an officially (ie Literature referenced) accepted conclusion.