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mind over matter

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Posted 07 March 2011 - 08:53 AM

Is it a requirement to establish a PROCEDURE for each of the following?

1) monitoring each CCP
2) corrective action (this is mandatory)
3) verification procedures together with review procedures that the HACCP plan is working effectively.

I understand #2 it’s required but I think there is no mandatory requirement for a documented procedure for #1 & 3.
Will work instructions suffice for any OTHER documents the organizations needs other than a procedure?




GMO

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Posted 07 March 2011 - 10:20 AM

Well if you don't have a procedure for monitoring a CCP what do you train people who are doing the monitoring against? What do you do if you want to change that way of monitoring? What if you leave and someone else starts? Will something vital be missed? This can be put into another document not called a procedure though, like an SOP or WI.

I would personally have an overarching verification document referencing which verification procedures apply for each CCP or PRP but then there may be procedures underneath this on how to conduct the verification; examples would include an internal audit procedure, a microbiological swabbing procedure, a water sampling procedure. Likewise these could be in SOP / WI form if you want. If you don't have this, again, how do you train people to do it and what do you train them against?



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mind over matter

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Posted 07 March 2011 - 10:41 AM

For #3, all we have is a policy statement of verification and a blank form (verification plan). There are fixed fields where users are required to enter information and the form indicates what constitutes the evidence that HACCP plan is working effectively.



GMO

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Posted 07 March 2011 - 01:07 PM

For #3, all we have is a policy statement of verification and a blank form (verification plan). There are fixed fields where users are required to enter information and the form indicates what constitutes the evidence that HACCP plan is working effectively.


Sorry I don't quite understand this. I take it the form is electronic? Does it specify what verification activities are required? In which case that might be fine but I would still say, how does a person know how to do an audit or who is trained in auditing or what the definition of "audit" is in your site? How does a person know how to do some microbiological sampling or where to sample and when? Etc. etc.


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Posted 07 March 2011 - 04:16 PM

Dear GMO,

I totally agree with yr logic however I hv met auditors who prefer a stripped down presentation, eg everything condensed into small squares of a table, often of microscopic font size. Instructional -level manuals were considered not as required by the standard. net result - yet another argument. :smile: I hv seen consultant's programs adopt similar approach also. Ultimately one gets the 1-page/product haccp plan, hv seen this too and was fully approved. Perhaps a case of "familiarity breeds contempt". :smile:

Rgds / Charles.C


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Charles.C


mind over matter

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Posted 08 March 2011 - 03:17 AM

Sorry I don't quite understand this.



Validation and Verification policy statement

The Company has ensures that the hazards identified are complete and correct and they will effectively be controlled under the proposed plan through validation process prior to implementation of HACCP Plan. Validation is performed by demonstrating that:

• The established list of potential hazards is based on sound scientific data and has included all hazards;
• The questions to assess the significance are answered using sound scientific and technical knowledge;
• The control measures (general & specific) are appropriate to control the hazards
• Fluctuation of control parameters (equivalent to a process criterion) within the defined critical limits will not affect the safety of the product;
• The parameters and methods used to monitor the control measures are appropriate;
• Correction and corrective actions are appropriate and shall prevent the release of unsafe products and provide evidence that the situation can be corrected immediately.

The Company ensures that verification of the HACCP system, to determine compliance with the specifications of the HACCP system and to confirm that the HACCP system is working effectively through the application of (auditing) methods, procedures, test (including random sampling and analysis) and other evaluation, in addition to monitoring.

The verification process shall address, as appropriate, the following topics:

• Review the HACCP system and its corresponding records;
• Analysis of (near) recalls and product disposition;
• Assessment of all specific control measures, nonconformities and corrective actions taken to seek confirmation of implementation and effective control of CCP’s;
• Compliance of the actual flow diagrams and layout with the documented situation;
• Compliance of the PRP documents with operational situation;
• Analysis of customer and consumer complaints related to hygiene and food safety;
• Review of analytical outcome of random sampling and analysis of product;
• Evaluation of conformity with applicable legislation and regulations and identification changes legislation and regulations concerning food safety;
• Review of gaps between current and desired level of knowledge, awareness and training staff with respect to hygiene and food safety, resulting in effective (on-the-job) training session;
• Consistency of the current documentation.Validation and Verification policy statement.

I take it the form is electronic? Does it specify what verification activities are required? In which case that might be fine

Not electronic.Please see attached sample Verification Plan.

but I would still say, how does a person know how to do an audit or who is trained in auditing or what the definition of "audit" is in your site?


We have a separate procedure on Internal Auditing. It's a mandatory to have one.

How does a person know how to do some microbiological sampling or where to sample and when? Etc. etc.

Perhaps this would be the problem. I'm not sure if internal auditors are trained to do some microbiological sampling etc. I guess they are not. Does this (lack of knowledge on microbiology) disquality an auditor to conduct an audit? Process owner (microbiologist or food technician) can assist the auditor.

Attached Files


Edited by Simon, 08 March 2011 - 08:48 PM.


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Posted 08 March 2011 - 07:04 PM

You need to have a procedure in place for monitoring a CCP including how it is done, critical limit, how often and who (not necessarily a specific person but even if says Operator it is ok). It also needs to be very clear in the corrective actions to be taken when CCP is out of control. You then need to ensure that the person carrying out the monitoring is very well trained (and should be re-trained a minimum oif annually) and has a good head on his/her head shoulders to be able to answer questions from external auditors (as when they are audiing, they almost always speak to anyone whose job iinvolves CCP monitoring).

As far as verificction is concerned, the exaple table by the previous poster should be adequate as long as you can back it up with the appropriate documentation; for example if you say that verification is carried out through internal audits, be prepared to show these audits (clearly showing details of checks on the CCPs) to an external auditor.



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D-D

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Posted 09 March 2011 - 12:04 PM

I have everything on the CCP control chart:

- CCP number
- Process Step
- Hazard being controlled (Why we are doing it)
- Control measure (How to control the hazard)
- Critical limit (What limit relates to safety)
- Responsibilities (Who is doing the Hows, Whats and Whens)
- Monitoring procedure (When is the check done)
- Corrective action
- Records (Where to record the CCP check i.e. on the run sheet).

Apart from the rest of the HACCP documents I don't have any specific "procedure" as the chart is very clear as is the accompanying training.

Verification: Counter-signature by supervisor
Validation: I still need to do that! (Fortunately we have 40 years history and our products do not spoil or support bacterial growth etc).


Edited by D-D, 09 March 2011 - 12:06 PM.


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GMO

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Posted 09 March 2011 - 01:07 PM

I have everything on the CCP control chart:

- CCP number
- Process Step
- Hazard being controlled (Why we are doing it)
- Control measure (How to control the hazard)
- Critical limit (What limit relates to safety)
- Responsibilities (Who is doing the Hows, Whats and Whens)
- Monitoring procedure (When is the check done)
- Corrective action
- Records (Where to record the CCP check i.e. on the run sheet).

Apart from the rest of the HACCP documents I don't have any specific "procedure" as the chart is very clear as is the accompanying training.

Verification: Counter-signature by supervisor
Validation: I still need to do that! (Fortunately we have 40 years history and our products do not spoil or support bacterial growth etc).



As long as the training is against a document that would be fine but if it isn't, how do you know if different trainers are training the same thing?

I would argue that a counter signature alone is not sufficient verification for any CCP. Sure, it's verification that the record has been completed but it lacks that completely independent 'double check' element that things like complaints, micro and audit have in their favour.



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D-D

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Posted 09 March 2011 - 05:18 PM

As long as the training is against a document that would be fine but if it isn't, how do you know if different trainers are training the same thing?


The training is done from a presentation after which there is a 12 question test. Anyone getting less than 8/12 and/or failing the CCP questions has to re-do the training and test again.

I would argue that a counter signature alone is not sufficient verification for any CCP. Sure, it's verification that the record has been completed but it lacks that completely independent 'double check' element that things like complaints, micro and audit have in their favour.


According to the CCP control chart, the operator is responsible for checking the CCP (signature) and the supervisor is responsible for verifying this has been done (signature). There are still things like complaints analysis that should reflect that HACCP is working and we have internal audits but micro is not relevant here.


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Charles.C

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Posted 10 March 2011 - 03:02 PM

Dear All,

It appears to me that a lot of this thread is debating -

(a) what constitutes a procedure ?

(b) is a documented procedure necessary ?

Purely as an example, I can still remember one auditor's questioning flow for monitoring / corrective actions -

Have you got a procedure for this ?
Is it written down?
Please show me ?

Straight from the auditor's handbook i believe. I don't know what the response to a "No" would hv been. Possibly the start of an iso 9001-type argument. Take yr pick i suppose where it is not spelled out in black and white..

The approach whereby the necessary steps are placed on a chart rather than a specific "document" are I'm sure usually acceptable (assuming they are meaningful [as per GMO's requirement] even if hardly iso-like (although i hv seen an identical concept used for an approved iso 9001 procedural manual).

Personally i guess I am "old school". i simply make specific procedures (often aka work instructions for many items) as the need arises. Avoids conceptual arguments.

Can make 4 criticisms of the policy statement given earlier -

1. I don't like the use of a combined Va / Ve statement. The two aspects have been de facto separated in the 22004 "revision". Not precisely incorrect, just confusing IMO.

2. The quote below is inadequate IMO for a policy statement (= meaningless). (But no doubt politically acceptable of course :smile: .)

The parameters and methods used to monitor the control measures are appropriate


3. The word "calibration" nowhere appears in the policy statement. IMEX, this is a universal expectation and particularly in view of the standard itself.

4.The words "internal audit" nowhere appear in the policy statement. IMEX, this is a universal expectation and particularly in view of the standard itself.

@D-D. Frankly i'm amazed that you audited successfully without a validation section or the equivalent. (or perhaps you haven't reached that step yet - I was not clear? :smile: )

Rgds / Charles.C

Kind Regards,

 

Charles.C


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Posted 10 March 2011 - 04:27 PM

Dear All,
1. I don't like the use of a combined Va / Ve statement. The two aspects have been de facto separated in the 22004 "revision". Not precisely incorrect, just confusing IMO.
Rgds / Charles.C


Yes and it looks very much like a cut and paste job as well :smile:

Regards,

Tony


mind over matter

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Posted 10 March 2011 - 05:13 PM

Yes and it looks very much like a cut and paste job as well :smile:

Regards,

Tony

What do you mean by cut and paste job?


mind over matter

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Posted 10 March 2011 - 05:22 PM

Can make 4 criticisms of the policy statement given earlier -
1. I don't like the use of a combined Va / Ve statement. The two aspects have been de facto separated in the 22004 "revision". Not precisely incorrect, just confusing IMO.

2. The quote below is inadequate IMO for a policy statement (= meaningless). (But no doubt politically acceptable of course :smile: .)


3. The word "calibration" nowhere appears in the policy statement. IMEX, this is a universal expectation and particularly in view of the standard itself.

4.The words "internal audit" nowhere appear in the policy statement. IMEX, this is a universal expectation and particularly in view of the standard itself.

Points are well taken. Thank you for giving your comments for improvement.


mind over matter

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Posted 11 March 2011 - 05:13 AM

Can make 4 criticisms of the policy statement given earlier -

1. I don't like the use of a combined Va / Ve statement. The two aspects have been de facto separated in the 22004 "revision". Not precisely incorrect, just confusing IMO.

2. The quote below is inadequate IMO for a policy statement (= meaningless). (But no doubt politically acceptable of course :smile: .)


3. The word "calibration" nowhere appears in the policy statement. IMEX, this is a universal expectation and particularly in view of the standard itself.

4.The words "internal audit" nowhere appear in the policy statement. IMEX, this is a universal expectation and particularly in view of the standard itself.

@D-D. Frankly i'm amazed that you audited successfully without a validation section or the equivalent. (or perhaps you haven't reached that step yet - I was not clear? :smile: )

Rgds / Charles.C

Actually it’s a combined validation, verification, corrective action, and internal audit. The actual title is “CORRECTIVE ACTION AND PROCESS VALIDATION AND VERIFICATION. You were right that “calibration” was not mentioned but I “internal audit” was mentioned. Below is the whole policy statement.



Corrections and corrective actions are taken to eliminate the cause of non-conformities in order to prevent recurrence according to Correction & Corrective Action Procedure.



Determining and implementing of corrective action includes the following stages:



· Reviewing nonconformities

· Determining the causes of nonconformities

· Evaluating the need for action to ensure that nonconformities do not recur

· Determining and implementing action needed

· Records of the results actions taken

· Reviewing corrective action taken





The Company has ensures that the hazards identified are complete and correct and they will effectively be controlled under the proposed plan through validation process prior to implementation of HACCP Plan.



Validation is performed by demonstrating that:



· The established list of potential hazards is based on sound scientific data and has included all hazards;

· The questions to assess the significance are answered using sound scientific and technical knowledge;

· The control measures (general & specific) are appropriate to control the hazards

· Fluctuation of control parameters (equivalent to a process criterion) within the defined critical limits will not affect the safety of the product;

· The parameters and methods used to monitor the control measures are appropriate;

· Correction and corrective actions are appropriate and shall prevent the release of unsafe products and provide evidence that the situation can be corrected immediately.





The Company ensures that verification of the HACCP system, to determine compliance with the specifications of the HACCP system and to confirm that the HACCP system is working effectively through the application of (auditing) methods, procedures, test (including random sampling and analysis) and other evaluation, in addition to monitoring.











The verification process shall address, as appropriate, the following topics:



· Review the HACCP system and its corresponding records;

· Analysis of (near) recalls and product disposition;

· Assessment of all specific control measures, nonconformities and corrective actions taken to seek confirmation of implementation and effective control of CCP’s;

· Compliance of the actual flow diagrams and layout with the documented situation;

· Compliance of the PRP documents with operational situation;

· Analysis of customer and consumer complaints related to hygiene and food safety;

· Review of analytical outcome of random sampling and analysis of product;

· Evaluation of conformity with applicable legislation and regulations and identification changes legislation and regulations concerning food safety;

· Review of gaps between current and desired level of knowledge, awareness and training staff with respect to hygiene and food safety, resulting in effective (on-the-job) training session;

· Consistency of the current documentation.



The Company planned an internal audit scheme taking into consideration the status and importance of the processes and areas to be audited, as well as the result of the previous audits. The audit criteria, scope, frequency and methods are defined. The responsibilities and requirements for planning and conducting audits, for reporting results and maintaining records are defined in a documented procedure.



The Company reviews & evaluates the results of the verification process at planned interval of at least every 6 months to ensure continuing suitability, adequacy and effectiveness of the HACCP-based Food Safety System.







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Posted 11 March 2011 - 09:13 AM

Dear MOM,

Thks for the extended version.

One more comment -

The Company ensures that verification of the HACCP system, to determine compliance with the specifications of the HACCP system and to confirm that the HACCP system is working effectively through the application of (auditing) methods, procedures, test (including random sampling and analysis) and other evaluation, in addition to monitoring.


I think there is a verb missing somewhere, probably in the first line. :smile:

Rgds / Charles.C

Kind Regards,

 

Charles.C


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mind over matter

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Posted 11 March 2011 - 11:16 AM

Dear MOM,

Thks for the extended version.

One more comment -



I think there is a verb missing somewhere, probably in the first line. :smile:

Rgds / Charles.C

planning?


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Posted 12 March 2011 - 11:18 AM

Dear MOM,

Example -

The Company ensures that verification of the HACCP system is carried out. This includes the determination of compliance with the specifications of the HACCP system and confirmation that the HACCP system is working effectively through the application of (auditing) methods, procedures, test (including random sampling and analysis) and other evaluations, in addition to monitoring.

(underline = a suggested textual change)

Rgds / Charles.C


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Charles.C


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mind over matter

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Posted 12 March 2011 - 12:35 PM

Dear MOM,

Example -

The Company ensures that verification of the HACCP system is carried out. This includes the determination of compliance with the specifications of the HACCP system and confirmation that the HACCP system is working effectively through the application of (auditing) methods, procedures, test (including random sampling and analysis) and other evaluations, in addition to monitoring.

Rgds / Charles.C

Ah, I think you were referring to validation. For example, we (audit team/organization) need to confirm if “cooking the Durian to 82 degree celcious for 5 minutes sufficient to kill E.Coli and staphylococ-cus aureus” is in fact capable of reducing the hazard to an acceptable level.


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Posted 14 March 2011 - 09:49 AM

@D-D. Frankly i'm amazed that you audited successfully without a validation section or the equivalent. (or perhaps you haven't reached that step yet - I was not clear? :smile: )


Oh Charles - we are NOWHERE NEAR ready for (BRC) audit yet! The HACCP plan is not bad apart from this gap; still needs some refinement but products are very low risk and covered by the plan. Validation of the CCPs should be a straightforward study (filtration and checking containers prior to use); it's everything else we need to sort out now...

Edited by D-D, 23 March 2011 - 08:14 AM.




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