12 replies to this topic

[Ataly Aguirre]

Good morning, all!

 

Has anyone had an incident where an untrained person performed a CCP check? How did you handle the situation?

[SQFconsultant]

You have a trained person review the the check that the untrained person did, you write it up as a corrective action,  and you provide training to the person that is untrained - documenting everything. It's an error and it happens.

[nwilson]

Ok this may be an unpopular opinion however, I consider anyone untrained in performing a critical control point verification as if the verification never occurred.  Unless someone qualified was witness to the verification check (then I would go down the same path as @SQFconsultant), otherwise I repass the product with a qualified individual.  My thinking is how can you be sure that the verification check was performed correctly if they are not trained in the proper process/procedure?  I have got a lot of push back from production staff on this, however only took one time to set the tone to not allow other staff to perform verification checks they are not trained on.  

[Scampi]

I'm with mWilson

 

the product needs to go on HOLD pending investigation and disposition

[G M]

Good morning, all!

 

Has anyone had an incident where an untrained person performed a CCP check? How did you handle the situation?

 

I'm inclined to agree with nwilson, but it depends a little bit on what kind of records are collected.

 

If they're recording some objective measurement in detail, it may be possible to review their numbers -- but if the observation requires operating a piece of equipment or making any kind of subjective evaluation, or is recorded as subjective (pass/fail) then I would treat it as if it didn't happen.

[jfrey123]

I see merits to both arguments above and would add that my choice would be heavily influenced by the type of process the CCP covers.  Yes, product should be on hold pending the full investigation.

 

If the CCP is fairly automated, say a computer-controlled cook process, and the check is to document verification of time and temps, SQFconsultant's point about having qualified individuals review the recorded data and approve it prior to release would be acceptable to me.  Interviewing the employee who wrongly performed the check to verify their understanding of how the check is done could be included in an investigation, and if they can correctly describe steps taken then it adds to the case for allowing product to be released.

 

If the CCP is more manual, say a cook process where employees have to control and adjust settings on equipment to ensure proper time/temp is met, then it gets a little riskier in my book.  Could be an employee who has seen the steps done 1,000 times but may not fully understand the implications.  A 'monkey see - monkey do' controlling a kill step would be pretty hard to justify.

 

Best example I can think of for my current biz:  one CCP in 2 of our plants is to verify the temperature of the rooms.  I can't remember the frequency off hand, but QA walks around with a clipboard and checks each room thermometer readout.  If an untrained employee did this check, but could show me what they did matches the SOP, and a trained QA tech can pull the data logs to show the record is accurate to what was data logged, then I'd be inclined to say the product integrity is safe.  In this example, I'd document the deviation, investigate past records closely to verify this isn't a common problem, discipline responsible parties, apply re-training to those who need it, and monitor for 3 extra months.

[Ataly Aguirre]

Thnak you everyone for the valuable feedback. THANK YOU ALL!

 

I will provide more details of the incident. The employee when through training and didnt pass the knowledge test for Metal Detector our CCP, someone was suppost be observing this person but looking at the video survalian the the trainer was not close enough to observ if the trainee was performing the procedure correctly, in fact the traininee was doing the process wrong. The product is on Hold. Because the checks were perform by an untrained employee will that pose a hazard to the product, would you consider the product unsafe to be place on the market.?

 

Your feedback is apprecited.

[Ataly Aguirre]

Thnak you everyone for the valuable feedback. THANK YOU ALL!

 

I will provide more details of the incident. The employee when through training and didnt pass the knowledge test for Metal Detector our CCP, someone was suppost be observing this person but looking at the video survalian the the trainer was not close enough to observ if the trainee was performing the procedure correctly, in fact the traininee was doing the process wrong. The product is on Hold. Because the checks were perform by an untrained employee will that pose a hazard to the product, would you consider the product unsafe to be place on the market.?

 

Your feedback is apprecited.

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[Scampi]

Your CCP deviation procedures should be plainly laid out telling you what to do with the product---what does it say?

 

if you can, run it through the MD 

[jfrey123]

Fantastic details @Ataly.  With your investigation revealing the fact SOP wasn't followed (training SOP plus actual MD SOP), and evidence the MD checks were performed incorrectly, holding the product is the right move.  In your shoes, I'd likely have qualified staff re-run the products through the metal detector and document on a new form, and if they pass I would release the product.  Both the improper MD record and the new one become part of the batch record.

 

I'd document the finding as a HACCP deviation, document these investigation steps, record whatever discipline you feel is necessary for the employee (and more specifically the trainer), document the re-run of product in the MD with the results, then wrap it up.  As part of the CAPA, think closely about how you'll ensure the issue does not repeat.

 

And I agree with @Scampi, if your CCP SOP only includes instructions on what to do if the MD finds metal and doesn't outline what to do if the MD isn't used or is used incorrectly, you need to update the SOP.

[awalkers]

Hello, 

 

On the same line with the metal detectors and trained personnel. What would be your opinion, on training one person per production line to verify and outlearn the metal detector (CCP) because production feels like they are waiting to long to get QA to set up the metal detector between change overs?

 

Would that be a conflict of interest? I am afraid that because production is more interested on volume they might try to adjust the metal detector to a way that the product stop less times. (more for those that the conductivity change more often)

 

Would you agree to let production personnel to monitor and auto-learn metal detectors instead of quality technicians?

 

What do you think is the best approach?

 

Thank you.

Ana 

[jfrey123]

Smaller companies without dedicated QA staff often have to train and allow production operators to operate the CCP's.  When that's the case, it becomes QA's function to verify the parameters were properly set and the CCP functioned as written in your SOP.  You can have QA do spot checks of the employees running calibrations as an additional check throughout the year.

[GMO]

In the UK it's routine for production personnel to conduct their own checks of metal detectors.  I see no valid reason why they wouldn't.  Same as measuring temperatures out of an oven or monitoring pasteuriser critical limits etc.  That's not in small companies either.  In general the ethos in the last 15 years is all quality control type checks are performed by operators with quality assurance staff doing some level of verification of those checks but spending more time on auditing and coaching staff.

 

Not the same everywhere, there are some companies still stuck in the stone age but I'd say it's more common than not that businesses now take that route.