8 replies to this topic

[NutANDFruitFoodSafety]

Hi all - I am an SQF Practitioner for several years at a facility. We are paper heavy and almost everything is written down by a quality control person. This includes monitoring the startup, changeover, and cleaning of all productions. Please understand that we are a small facility so we do tens and tens of different small productions sometimes within a single day.

 

My question is, does the quality person need to be the one monitoring and verifying all startup and changeover items, or can they just check at the end of a production that they have in fact been done as self reported by the packer or production personnel themselves?

 

I have always found this type of monitoring vs verifying etc difficult to understand on a case by case basis.

 

One example, in order to clarify, would be a packer that is packing two different items on an order. We change packing tools in between, and as of now, that needs to be monitored and recorded by the quality person. Am I able to reduce that burden by having the packer themselves do that recording? Then at the end have the QC just verify that it has occurred? Or does that lack actual monitoring?

 

Thank you in advance.

[Scampi]

You do not, (and I would suggest should not) be doing ALL the process verifications

 

Training all the operators etc of what needs recorded, when and how

 

QC then can spend their time "overseeing" things and you can verify completed paperwork for accuracy and completness

[NutANDFruitFoodSafety]

You do not, (and I would suggest should not) be doing ALL the process verifications

 

Training all the operators etc of what needs recorded, when and how

 

QC then can spend their time "overseeing" things and you can verify completed paperwork for accuracy and completness

Thank you for the response. I believe my confusion is with the monitoring. Are you suggesting that the monitoring is basically the end of production paperwork verification that the quality person would be carrying out, as opposed to actually visually watching the production personnel carry out these tasks?

Thanks again.

[Scampi]

The QC tasks should be different from operational paperwork (like change overs)

 

So in the change over example, operations would document the change over, and that the proper packaging was now being used, QC would visually verify that to be correct

 

I think your perhaps confusing monitoring (verification) with operations.   

 

Why do you think your QC needs to visually monitor the tasks, does OPs routinely make mistakes?  Isn't there something more important they could be doing with their time?

[GMO]

Visual observation of people carrying out tasks is not normally done as an activity for every monitoring task.

 

So, say you have a changeover. What I'd expect is the operator or team leader on the line to record the changeover tasks are done. That might be verified on occasions by the manager in the area or QA but not every time.

 

• Monitoring is the record to make sure that activities are completed as designed.
• Verification is an independent check of those activities. Verification must be carried out by another person and (not always but usually) is a sampling exercise. These are activities commonly undertaken by team leaders, managers and QA team members and may include checking paperwork, checking behaviours on monitoring activity, auditing and swabbing.

[NutANDFruitFoodSafety]

Ok thank you to both. I appreciate the responses very much.

 

It sounds like I am thinking of monitoring as being too close to verifying.

 

If I understand correctly, you both would suggest the operator to perform and also fill out paperwork for startup, changeover, cleaning, etc.

 

The quality person would then get the paperwork and sign off that it was performed.

 

Finally, during our weekly inspections the quality person could do these activities themselves as part of a weekly verification.

 

Does that sounds sort of like what you are pointing to?

 

Thank you

[Scampi]

you've got it

[G M]

Ok thank you to both. I appreciate the responses very much.

 

It sounds like I am thinking of monitoring as being too close to verifying.

 

If I understand correctly, you both would suggest the operator to perform and also fill out paperwork for startup, changeover, cleaning, etc.

 

The quality person would then get the paperwork and sign off that it was performed.

 

Finally, during our weekly inspections the quality person could do these activities themselves as part of a weekly verification.

 

Does that sounds sort of like what you are pointing to?

 

Thank you

 

 

You can use different types of verification at different frequencies to get the best of each.  For example the majority of your verifications can be a Record Review, where you are simply reviewing the recorded observations your team members are making during the process, for compliance with minimums/maximums and completeness of the record -- this is much less demanding on your time.  Then at a lower frequency like once a week you observe them perform one of these tasks as a Direct Observation to ensure the technique used is correct etc.

 

When you have new team members, or have a non conformance, you can use an increased frequency of direct observation as a tool to demonstrate a greater level of oversight.

[GMO]

Agree with all of the above.

 

Personally I'm not a massive fan of record reviews because I think that only shows your records are right rather than the process being right (but I know US regulators love it) but I'm a big fan of observing people doing the checks, perhaps only once a week, certainly as a sampling exercise and I think that's better than a QA doing them themselves. Combined with a record review, that's much more robust. 

 

Validation - can it work?

Monitoring - evidence it is working

Verification - independent evidence it's still working (not necessarily real time and is normally a sampling exercise)