9 replies to this topic

[trubertq]

Morning Guys,



Process validation... at CCps... how often would this need to be done? We have all our CCps validated but some date back to 2000... the process hasn't changed and neither has the equipment but I wonder should the validation be repeated afte a certain period of time?





It never ends... you think you've turned a corner and another mountain appears...sorry for mixing the metaphors. I am depressed today

[GMO]

Validation is something which should happen prior to installation so IMO, no, it does not need revalidation, unless you have made a change. That change might be small but it's worth considering.

Perhaps your best bet is to audit your validation yearly for each CCP in detail and confirm to yourself that the report / records you have are sufficient and your verification is not indicating any problems with the CCP. After all, if there were problems with the validity of your CCPs, you would know pretty sharpish!

[agwanda]

Dear GMO,

Supposing there are CCPs that are to be monitored after a given frequency, don't you think it is important that they be checked if they are taken care of? Wouldn't this be a validation process?

For instance, if my sterilizer broke down and had to be repaired. Should I not carry out checks on temperatures amy be followed by micro tests to check the operational efficiency(ie if the CL is exceeded)?

Agwanda

[GMO]

Dear GMO,

Supposing there are CCPs that are to be monitored after a given frequency, don't you think it is important that they be checked if they are taken care of? Wouldn't this be a validation process?

For instance, if my sterilizer broke down and had to be repaired. Should I not carry out checks on temperatures amy be followed by micro tests to check the operational efficiency(ie if the CL is exceeded)?

Agwanda

I don't know about sterilisers but in your first sentence "checked if they are taken care of", ongoing checking would be verification. So for example, ongoing microbiological testing, auditing etc. If you've had a change and a major breakdown of a machine could I suppose be a change then you may have to revalidate, however, depending on the machine, if the same settings and same performance is again achieved after the breakdown, it would probably be possible to argue revalidation is not required especially as monitoring is in place presumably?

[MKRMS]

Hi trubertq,

I would suggest to review your HACCP system annually and make necessary amendments in all areas where you can identify shortfalls. If nothing has changed in your business, a review might be quick and easy :-)

There is a difference between validation (ensuring that a measure does what it is intended for) and verification (ensuring every control that has been selected is used reliably, accurately and consistently).

Selected controls must be validated before they can be used to manage food safety with a HACCP system. It does not make sense to periodically re-validate a control (e.g. a critical limit); a control is either valid (does what it is supposed to do) or not. Repeated validation should give identical results. If new scientific evidence suggests that an existing process or control which has previously been thought to be safe (valid) really is unsafe, this control or process must be changed and the changes must be newly validated.

Ongoing verification is crucial for process control - you must ensure that the selected validated controls are used effectively and accurately. Inaccurate control (e.g. incomplete or inaccurate monitoring and recording of critical controls) will lead to a loss of process control and inadvertently cause the release of potentially unsafe material on the market. Under HACCP rules it is recommended that verification is carried out at a frequency that is "sufficient to confirm that the HACCP system is working effectively." (CAC/RCP 1-1969, Rev. 4-2003).

Hope this helps

Matt

[GMO]

Hi trubertq,

I would suggest to review your HACCP system annually and make necessary amendments in all areas where you can identify shortfalls. If nothing has changed in your business, a review might be quick and easy :-)

There is a difference between validation (ensuring that a measure does what it is intended for) and verification (ensuring every control that has been selected is used reliably, accurately and consistently).

Selected controls must be validated before they can be used to manage food safety with a HACCP system. It does not make sense to periodically re-validate a control (e.g. a critical limit); a control is either valid (does what it is supposed to do) or not. Repeated validation should give identical results. If new scientific evidence suggests that an existing process or control which has previously been thought to be safe (valid) really is unsafe, this control or process must be changed and the changes must be newly validated.

Ongoing verification is crucial for process control - you must ensure that the selected validated controls are used effectively and accurately. Inaccurate control (e.g. incomplete or inaccurate monitoring and recording of critical controls) will lead to a loss of process control and inadvertently cause the release of potentially unsafe material on the market. Under HACCP rules it is recommended that verification is carried out at a frequency that is "sufficient to confirm that the HACCP system is working effectively." (CAC/RCP 1-1969, Rev. 4-2003).

Hope this helps

Matt

Matt, that was kinda what I was trying to say but you put it a lot better!

[trubertq]

That's what I had figured just wanted back up. We do review HACCP annually, indeed more often than that as things keep changing, but the CCPs are not changed so I figured that validation is ok so long as our records verify that they are still working.



Pre Audit Wednesday... Fingers crossed the list won't be too long

[George @ Safefood 360°]

Hi Guys - interesting post.

I agree with all the advice given to trubertq's question however be a little cautious about saying that once a CCP is validated it does not need to be vaidated again. Of course this is true in most cases but like everything in food safety it is not always the case .

If a process or product has not changed and the CCP itself has not changed it's reasonable to assume that the CCP should not need revalidation. However there may be changes beyond these that will require a CCP to be re-validated. For example the issue of emerging pathogens needs to be given due regard.

A CCP that has a lethal impact on specific pathogens today may not be adequate to control a newly emerging pathogen i.e. new scientific data may dictate re-validation is required even though the product, process and CCP have not changed.

Matt has touched on this already and suggests the control or process must be changed and the changes must be newly validated. True - however it should not be taken automatically that changing the process etc is required. Re-validation of the CCP might show that the CCP is capable of controlling the emerging hazard without change.

So in short, it should not be necessary to re-validate a CCP but keep an eye on emerging hazards and any newly available scientific data.

George

[GMO]

Hi Guys - interesting post.

I agree with all the advice given to trubertq's question however be a little cautious about saying that once a CCP is validated it does not need to be vaidated again. Of course this is true in most cases but like everything in food safety it is not always the case .

If a process or product has not changed and the CCP itself has not changed it's reasonable to assume that the CCP should not need revalidation. However there may be changes beyond these that will require a CCP to be re-validated. For example the issue of emerging pathogens needs to be given due regard.

A CCP that has a lethal impact on specific pathogens today may not be adequate to control a newly emerging pathogen i.e. new scientific data may dictate re-validation is required even though the product, process and CCP have not changed.

Matt has touched on this already and suggests the control or process must be changed and the changes must be newly validated. True - however it should not be taken automatically that changing the process etc is required. Re-validation of the CCP might show that the CCP is capable of controlling the emerging hazard without change.

So in short, it should not be necessary to re-validate a CCP but keep an eye on emerging hazards and any newly available scientific data.

George

Yes and emerging pathogens / changed in scientific knowledge should be part of your review and change process to capture this but in general revalidation should not be required. If you wait anyway until a specified review date to revalidate and a new pathogen has emerged in the interim that would be an issue which is why HACCP should be in the back of your mind and being informed (and actively reviewing) all information on emerging issues is important.

[Anish]

Well said by all in the above posts. Validation should be before implementation and atleast once in every year and also anytime whenever you find any problem of market complaint /complaint emerged due to CCP failure. Verification is something different which should be done atleast in a weekly interval.

Edited by Anish, 12 July 2011 - 12:10 PM.