10 replies to this topic

[excellens]

Hi to all,

We are implementing the Prerequisites programs in our plant. In order to do that, the Food Safety Team analyzes the best practices available, approve the program and prepare an audit for each program. That way we can evaluate every program with different frequencies based on compliance data.

Now the question.

The ISO22K 7.10.2 talk about non compliance based on operative PPr's and CCP's.

When we do the inspection and find non conformities to a PRP program (example: the joints in the floor are not smooth, the floor has cracks, etc.). Were not having a non compliance with operative PPr's and CCP's.

Should we include them as non conformities based on 7.10.2, and prepare corrective actions? or should we handle those audits separately and just prepare inspection reports?

Regards

Horacio Lomba

[Erasmo]

Hi to all,

We are implementing the Prerequisites programs in our plant. In order to do that, the Food Safety Team analyzes the best practices available, approve the program and prepare an audit for each program. That way we can evaluate every program with different frequencies based on compliance data.

Now the question.

The ISO22K 7.10.2 talk about non compliance based on operative PPr's and CCP's.

When we do the inspection and find non conformities to a PRP program (example: the joints in the floor are not smooth, the floor has cracks, etc.). Were not having a non compliance with operative PPr's and CCP's.

Should we include them as non conformities based on 7.10.2, and prepare corrective actions? or should we handle those audits separately and just prepare inspection reports?

Regards

Horacio Lomba

Hola Horacio,
Please see 8.4.2 ... Yo have to take appropiate action based on the HACCP team assessment of verification activities; those appropiate actions include Corrections (7.10.1) and / or Corrective Actions (7.10.2).
Saludos!

[angelica]

Horacio

I agree with Erasmo. In my opinion 8.4 is the appropriate, rather tan 7.10.2, in this case.

I mean, you audit and then you take actions according to your findings.

Regards

Angélica

[Biss]

hi

I also agree with you. it should come under the internal audit

[QA trainee]

Hi all
Im hoping to help by sharing some light on how we managed the PRP's at our plant.
From my understanding of the Standard, the PRP's are broken down into two parts namely your management (which is done daily for example) and the verification (which is the internal audit for example).
The PRP should document should state exactly how the PRP is managed on a daily basis, and the verification process will check if it is being done as it is supposed to be.
Part of the verification process is corrective actions.
So in order to ensure that your the PRP goes back to working the way it should be, corrective actions must be done!

Remember that if we dont CORRECT the problem, their is no point in internal auditing and auditors always seem to point that out first.

hoped to have helped, thats how we interpreted the whole PRP issue.

Also just to add, i think the standard draws alot of focus to how we manage the described PRP's because if the PRP program is well established and verified, then majority of the food safety controls will be in place already. This means the Food safety management system will have a greater confidence in its food safety and we dont rely 100% on our HACCP plans. Its a synergistic effect ensures food safety

Please correct me if i am wrong?

[Charles.C]

Dear All,

I have to say that as a non-user of ISO 22000, the last post generally makes very logical sense IMO in contast to the meandering text of the standard itself. I notice that there are no specific guidance items on the topic posted here in ISO 22004 suggesting that the authors assumed that the natural flow of monitoring / verification of PRPs would automatically dictate any associated necessity / use for corrective actions. (I recall that some posters believe that ISO22k does not require “monitoring” of PRPs; well, I can only say that others disagree). As per the first post significant cracks in the floor would surely be “acted” on by a daily "routine".

However I would disagree over the seeming tendency to regard the pre-requisite program as a separate entity from the “HACCP” plan. In fact the original concept of HACCP to mu understanding was that the control of pre-requisite elements (mainly = GMP) is a crucial requirement within the implementation of the overall HACCP system. Some people still prefer the HACCP plan in this more integrated format although the auditors may not like it (more x-referencing and work involved).

Rgds / Charles.C

@BTW - QA Trainee, excellens, Welcome to the Forum !

[excellens]

Thanks everybody for your comments,

QC Trainee and Charles, agree 100%. That's the reason to take time in the preparation of the written PPR's in order to prepare a HACCP program as bulletproof as possible. Our PRP's are based in the Canadian Food Inspection Agency's Food Safety Enhancement Program Manual.

http://www.inspectio...ue/tablee.shtml.

Also used the AIB GMP and Prerrequisite Guide https://secure.aibon...alogNbr=06-1465.

The system includes inspection reports for each PPR (in some cases, we have one report for more than one PPR), based on monitoring frequencyand proximity. The audit of the PPR's (verification), on the pre-determined frequency (approved by the Food Safety Team) includes the evaluation of the PPR's performance at the time of audit, inspection reports and the corrective actions from last audit.

We have been preparing Non Confomities reports based on the findings of the audits, and start corrective actions based on them. The question was wether to

Erasmo, Angelica, Bliss. Thanks, we'll put those audits under 8.4.

[Erasmo]

Dear All,

I have to say that as a non-user of ISO 22000, the last post generally makes very logical sense IMO in contast to the meandering text of the standard itself. I notice that there are no specific guidance items on the topic posted here in ISO 22004 suggesting that the authors assumed that the natural flow of monitoring / verification of PRPs would automatically dictate any associated necessity / use for corrective actions. (I recall that some posters believe that ISO22k does not require “monitoring” of PRPs; well, I can only say that others disagree). As per the first post significant cracks in the floor would surely be “acted” on by a daily "routine".

However I would disagree over the seeming tendency to regard the pre-requisite program as a separate entity from the “HACCP” plan. In fact the original concept of HACCP to mu understanding was that the control of pre-requisite elements (mainly = GMP) is a crucial requirement within the implementation of the overall HACCP system. Some people still prefer the HACCP plan in this more integrated format although the auditors may not like it (more x-referencing and work involved).

Rgds / Charles.C

@BTW - QA Trainee, excellens, Welcome to the Forum !

Well Charles, In my opinon ISO/TS-22004 is not a very good guidance in some parts of sections 7 & 8, but we need to remember that 22000 is for all organization in the food chain (from feed to restaurants) so it is not easy to have a guidance for all organization. In 22000 the HACCP plan is the result of the Hazard Analisis as well in QMS the Quality Plan is the result of Quality Planning, so PRP's could be " separated" of the HACCP plan, both PRP's and HACCP plan are an important parts of the HACCP System (Food Safety Management Sistem). I regularly audit an organization in 9001 and HACCP I'm still questioning them why they have a QMS Manual and a HACCP manual, it is not prohibited I think is not a good idea, they are duplicating a lot of activities.

Saludos.

[Suzuki]

Suitability of PRP design appropriate to the FBO's needs is the result of continual system validation and verification using respective monitoring activity data from OPRPs and HACCP Plan.

Review analysis for intensification or improvement of PRPs may derive from various assessment techniques and application of specific references and as such, is not restricted to just internal audit under 8.4.1.

For example - during an emergency event, it is not possible to apply 8.4.1 to initiate corrective actions and corrections as it would be too late.

Internal audit procedure is after all just another PRP which itself needs to be verified from time to time for currency and effectiveness under continuing dynamic circumstances in process environment.

Edited by Suzuki, 06 December 2008 - 04:55 AM.

[S.U.Siddiqui]

Hi Horacio,

As per requirement of 7.10.1 and 7.10.2, corrections and corrective actions shall be initiated in case of loss of control of OPRP and deviation of CCP. However, this statement does not bound you to take corrections and corrective actions ONLY in these 2 cases.

You can always initiate corrective actions to maintain the integrity of your FSMS and shall not wait for OPRP or CCP violation to occur. Simply fill out an NC report and initiate corrections and corrective actions.

Thats the way it is

Regards
Siraj

[Zeeshan]

Adhering with the

1) original question

When we do the inspection and find non conformities to a PRP program (example: the joints in the floor are not smooth, the floor has cracks, etc.). Were not having a non compliance with operative PPr's and CCP's.

Should we include them as non conformities based on 7.10.2, and prepare corrective actions? or should we handle those audits separately and just prepare inspection reports?

2) and the quote of Suzuki

Review analysis for intensification or improvement of PRPs may derive from various assessment techniques and application of specific references and as such, is not restricted to just internal audit under 8.4.1.

For example - during an emergency event, it is not possible to apply 8.4.1 to initiate corrective actions and corrections as it would be too late.

3) and the requirement of ISO 22K (Clause 7.2)
Verification of PRP(s) shall be planned (see 7.8) and PRP(s) shall be modified as necessary (see 7.7). Records of verifications and modifications shall be maintained.


IMHO, the correct way to handle nonconformities related to PRP's should be reviewing implementation actives of existing PRP or modification of existing PRP as necessary. Also this should be done in compliance with the above statement of Clause 7.2.

IMO, 7.10.2 and 8.4.2 should not be considered in the scenario of original question unless situation arises in a integrated management system (9001+HACCP or 9001+22K) where we will be justified to call actions to remove causes of nonconformity - corrective actions.

Why should we follow the strict requirements of 7.10.1 & 7.10.2 if the standard does not want them to be followed in case of noncompliance in PRP???

Regards: