Hallo Wayne,But, I wonder whether you could share with us your model for validation and verification.
what exactly do you need?
Greetings
Andrea
Posted 06 June 2006 - 07:16 AM
Hallo Wayne,But, I wonder whether you could share with us your model for validation and verification.
Posted 07 June 2006 - 02:22 PM
Hallo Wayne,
what exactly do you need?
Greetings
Andrea
Posted 11 June 2006 - 07:46 PM
Can anybody help Wayne out?
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Posted 13 June 2006 - 10:21 AM
I am looking for a validation and verification model. A simple graphic diagram will do (only if you have one).
Posted 13 June 2006 - 04:50 PM
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
Posted 06 July 2006 - 04:41 PM
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):
Posted 12 July 2006 - 08:42 PM
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):
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Posted 15 July 2006 - 04:48 PM
Thank you Charles.
Posted 19 July 2006 - 08:15 PM
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?
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Posted 02 September 2006 - 12:23 AM
Andrea
I am looking for a validation and verification model. A simple graphic diagram will do (only if you have one).
Thanks & Regards
Wayne
Posted 02 September 2006 - 05:08 PM
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
Kind Regards,
Charles.C
Posted 27 September 2013 - 05:31 PM
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
Posted 28 September 2013 - 12:27 AM
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
Kind Regards,
Charles.C
Posted 30 September 2013 - 02:42 PM
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
Posted 30 September 2013 - 08:06 PM
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
Kind Regards,
Charles.C
Posted 02 October 2013 - 03:55 PM
Dear Charles,
Thank you very much for your reply. You have provided me with excellent information and examples.
Regards,
Esther
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