Looking for a validation and verification model for ISO 22000

But, I wonder whether you could share with us your model for validation and verification.

Hallo Wayne,
what exactly do you need?
Greetings
Andrea

Hallo Wayne,
what exactly do you need?
Greetings
Andrea

Andrea

I am looking for a validation and verification model. A simple graphic diagram will do (only if you have one).

Thanks & Regards
Wayne

Can anybody help Wayne out?

I am looking for a validation and verification model. A simple graphic diagram will do (only if you have one).

You mean something like this?

Andrea

Andrea

Many thanks for the attempts you have made.

This is a PDCA cycle as proposed by the FSMS committee. It is not exactly what I am after. What I would like to find out is - how validation, verification and data implementation can fit into a self explanatory diagram. This would provide us a quicker way to assess the validity of a FSMS with NO confusion.

Thanks again

Wayne

Wayne,

I have posted a previous thread about "verification AND validation that you may have missed out since you are fairly new to this forum.

There are no tables or summarized notes but you need to read it ALL to understand the issues of V & V.

Think this is what you are looking for (this is a re-post):

Wayne,

I have posted a previous thread about "verification AND validation that you may have missed out since you are fairly new to this forum.

There are no tables or summarized notes but you need to read it ALL to understand the issues of V & V.

Think this is what you are looking for (this is a re-post):

Thank you Charles.

Thank you Charles.

Charles

The Codex has produced a very good piece of document for validation & verification. I would think it would be more useful if someone can come up with a practical diagramatic model ( say, the relationship between data implementation and data verification and data validation). Surely, this could further enhance the understanding of the new Standard. Would someone (generously) like to share this with us?

Regards
Wayne

The Codex has produced a very good piece of document for validation & verification. I would think it would be more useful if someone can come up with a practical diagramatic model ( say, the relationship between data implementation and data verification and data validation). Surely, this could further enhance the understanding of the new Standard. Would someone (generously) like to share this with us?

Can anyone help Wayne out on this one?

Andrea

I am looking for a validation and verification model. A simple graphic diagram will do (only if you have one).

Thanks & Regards
Wayne

Hello Wayne

The following procedure model may help you with your validation and verification initiatives.

Lorne

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4 Procedure - Verification planning - (ISO 22000 sub-clause 7.8).

4.1 The planning and development of instructions for the HACCP plan follow a sequence of activities that lead to the verification of the FSMS where:

- Product description and intended use reports are provided with Form 1 and Form 2.
- Process flow diagrams and plant schematics are detailed with Form 3 & Form 4.
- Prerequisite program action points are detailed with Form 5.
- Regulatory action point plans are detailed with Form 6.

4.2 Verification is a program to ensure that the planned monitoring activities to achieve the expected food safety performance have been adequately selected. The Food safety team plays a major role in the verification initiatives.

4.3 To supplement the review, analysis and updating of food safety programs and plans, the following Food safety team activities support verification planning:

- A minimum of (2) Food safety team member verification signatures appear on the operational forms listed in above par 4.1. This action provides the verification that the monitoring activities have been adequately selected.
- The Food safety team meets regularly on a ‘weekly' basis during the early program phases to direct and oversee the implementation of the Food Safety Management System,
- The Food safety team meets regularly on a ‘monthly' basis to review and improve the implemented Food Safety Management System.
- Reports and / or minutes of meeting discussions provide the record of activities.

5 Procedure - Validation of control measure combinations - (ISO 22000 sub-clause 8.4).

5.1 Validation of control measures is a program to ensure that the planned monitoring activities to achieve the expected food safety performance continue to be adequate. The Food safety team plays a key role in the validation initiatives.

5.2 Prior to implementation of control measures included in Form 7 of the hazard analysis and in Form 10 of the HACCP plan, (and after subsequent changes), the Food safety team validates that:

- The selected control measures are capable of achieving the intended control of the food safety hazard(s) for which they are designated, and
- The control measures are effective and capable of, in combination, ensuring control of the identified food safety hazard(s) to obtain end products that meet the defined acceptable levels.

5.3 In the event that the result of the validation shows that one or both of the above elements cannot be confirmed, the control measure and/or combinations thereof are re-assessed and modified.

5.4 Modifications include, as needed, changes in control measures (i.e. process parameters, rigorousness and/or their combination) and/or change(s) in the raw materials, manufacturing technologies, and end product characteristics, methods of distribution and/or intended use of the end product.

5.5 To supplement the validation activities described in above paragraph 4, the Food safety team validate the control measures when:

- A minimum of (2) Food safety team member validation signatures appear on Form 7 of the operational PRP(s) and on Form 10 of the HACCP plan the HACCP plan. This action is confirmation that the selected monitoring activities continue to be adequate.

5.5 Verification and Validation results are made available as required for analysis as required for the procedure SOP-851, analysis of data for continual improvement.

5.6 The Food safety team activities and decisions determine the extent to which the FSM, the FSP and SOP procedures and other management systems are updated with update review procedure and modified as controlled documents per Control of documents procedure.

Dear Charlorne,

I'm sure your detailed contributions will be appreciated and shortly commented on by people who are more savvy on this subject than me.

I am not an I22k user/reader as yet so feel free to shoot these comments down. If I'm wrong, someone else will no doubt perform the same activity.
I was a bit confused over the positioning of validation and verification in yr proposal. Seemed rather more logical to position validation considerations first somehow. Yr item 4.2 seemed more like validation to my interpretation due to the word 'planned' rather than say 'implemented', not that I disagree in any way with yr later 5.1 etc.

Whatever, any input is always welcome.

Rgds / Charles.C

While conducting my company's internal audit, I found that the FSMS Validation SOP is very vague and does not relate to the FSMS. Could anyone post a FSMS Validation SOP that would serve as an example?

Some of the validation processes that I was thinking to include in the SOP are

- Employee's hand swabs on bacteria levels and/or environmental swabs, which would be analysed by an external laboratory

- Scales and Thermometers annual certification

Can anyone give me their thoughts on this and expand on some FSMS validation processes that I could include?

 

Thank you very much in advance.

 

Regards,

Esther

While conducting my company's internal audit, I found that the FSMS Validation SOP is very vague and does not relate to the FSMS. Could anyone post a FSMS Validation SOP that would serve as an example?

Some of the validation processes that I was thinking to include in the SOP are

- Employee's hand swabs on bacteria levels and/or environmental swabs, which would be analysed by an external laboratory

- Scales and Thermometers annual certification

Can anyone give me their thoughts on this and expand on some FSMS validation processes that I could include?

 

Thank you very much in advance.

 

Regards,

Esther

 

Dear Estherlev,

 

Please supply a little context, eg  - 

 

intended compliance standard if any, eg iso22000 ? paragraph of a standard if any ?

product

process

validation of what ?, if you mean the whole FSMS, this could involve every component, eg all the PRPs, OPRPs, CCPs ? (but maybe depending on yr standard)

 

Rgds / Charles.C

Dear Charles,

 

We want to comply with ISO 22000, 8.2 Validation of control measure combinations. We are having a hard time determining appropriate and feasible validation methods. Our idea behind taking Employee's hand swabs on bacteria levels and/or environmental swabs, which would be analysed by an external laboratory was to validate personnel hygiene practices.

 

We are mainly a distributor of fruits and vegetables. Our processing step refers to sorting and packing according to customer specifications. We distribute to restaurants, hotels, etc.

 

All help in regards to this matter would be greatly appreciated. We could also really use a Validation SOP as reference.

 

Thank you very much!

Esther

Dear Charles,

 

We want to comply with ISO 22000, 8.2 Validation of control measure combinations. We are having a hard time determining appropriate and feasible validation methods. Our idea behind taking Employee's hand swabs on bacteria levels and/or environmental swabs, which would be analysed by an external laboratory was to validate personnel hygiene practices.

 

We are mainly a distributor of fruits and vegetables. Our processing step refers to sorting and packing according to customer specifications. We distribute to restaurants, hotels, etc.

 

All help in regards to this matter would be greatly appreciated. We could also really use a Validation SOP as reference.

 

Thank you very much!

Esther

 

DearEstherlev,

 

Thks yr reply.

As per para.8.2, validation is oriented to control measures with scope as spelled out in the para. itself.

 

Although not explicitly stated, PRPs implemented in ISO22000 are not required to be validated (they are required to be verified). (As PAS220 [or its ISO equivalent] is currently a typical source, one might say that this document becomes an automatic self-validation.)

 

Accordingly it is necessary  to validate CCPs and OPRPs.

 

A generic ISO22000-type overall “Procedure” answer to yr query is in post #10 of this thread.

 

I assume you are familiar with the standard introductory / closing SOP layout.

Various routes / options to the detailed evidence for the procedural part of a SOP for iso22000-validation are possible. These are discussed in considerable detail in ISO 22004 which I hope you have available. The preferred approach(es) will depend on the specific control measure.

 

As an example of a tabular-type ISO22000 / SOP format which includes most of the potential routes, can see this example attachment (TonyC) which is from the iso22000 package available on this site –

vl1 - OPRP 4 Management of Cleaning Validation.pdf   153.73KB   270 downloads

 

As a detailed textual version of a  (general) haccp validation SOP using a “preliminary” study approach to validate a labeling control measure, can see this (Canadian) example –

 

vl2 - validation study, labelling control.pdf   152.46KB   249 downloads

 

Rgds / Charles.C

 

PS - ISO22004 also has an excellent presentation / discussion on the requirements for verification. The activities you mention regarding cleaning are probably more appropriate to this area, eg within the context of para.8.4.2

Dear Charles,

 

Thank you very much for your reply. You have provided me with excellent information and examples. 

 

Regards,

Esther