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Validation and Verification documentation requirements?!


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#1 Mahmoud.S

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Posted 09 November 2009 - 08:08 AM

Is it required in ISO 22k to have separate records detailing the activates of Validation and \ or Verification , for example a Verification plan, is it a FORM that needs to be filled for each hazarded or is it a Procedure? :helpplease:
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#2 Mahmoud.S

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Posted 09 November 2009 - 08:12 AM

Verification Plan


Activity

Purpose

Frequency

Method

Respon-sibility

Post Verification Actions

Verification of CCP Monitoring as described in HACCP Plan

To verify that CCPs are kept in control as per HACCP Plan

Daily

(In case of production)

1. Verify recording of CCP monitoring in following documents:

• A

• B

• C


2. Verify that implementation of HACCP Plan is effective.

FSTL

If verification does not demonstrate conformity with the planned arrangements, the FST shall take action to achieve the required conformity.


Following actions may be taken:


a- Review of existing procedures and communication channels.


b- Review of the conclusions of the hazard analysis, the established OPRP(s) and the HACCP plan.


c- Review of the PRP(s)


d- Review of the effectiveness of human resource management and of training activities.


Verification that input to Hazard Analysis is continually updated.

To update system according to changing circumstances

At any change in process / product / raw-materials / Infrastructure etc

1- Cross check the updating of Hazard Analysis Work sheet w.r.t. updating in following :


• Product Characteristics

• Flow Diagrams

• Process Description

• Control measure Categorization sheet.

FST

Verification of OPRP Monitoring as described in OPRP Plan

To verify that OPRPs are kept in control as per OPRP Plan

Weekly

1. Verify recording of PRP monitoring in following documents:

• A

• B

• C


2. Verify that implementation of OPRP is effective.

FST

Verification of Prerequisite Program Implementation as described in PRPs Plan

To verify that all PRPs included in PRPs Plan are implementated and are effective

Monthly

1. Verify recording of PRP monitoring in following documents:

• A

• B

• C


2. Verify that implementation of PRP is effective.

FST

Review of Monitoring and Corrective Action (in case of deviation in OPRP or CCP)

To show compliance with the Plans

Quarterly


FST

Verification that hazard levels are within identified acceptable levels

to ensure that levels of all the identified hazards are within specified acceptable levels.

Quarterly

Verify through QA-approved methods of verification that hazard levels are within acceptable levels identified in Hazard Analysis Work Sheet.

FSTL

Updation of FSMS

Record all system updation activities and report them as input to Management Review

Quarterly


FSTL

Planning & Scheduling of verification activities

To verify the compliance of system to ISO22000:2005 requirements

Yearly


FSTL

Comprehensive verification of ISO22000:2005

1- To verify the compliance of system to ISO22000:2005 requirements

2- To verify that all procedures requred by ISO 22000 and by the organization are implemented and effective.

Yearly

1- Perform 1st Internal Documentation Review to check

- Compliance of documented FSMS w.r.t. ISO22000:2005.

- Integrity of documented FSMS

2- Internal Auditing as per Internal Audit Plan

FST
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#3 Charles.C

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Posted 09 November 2009 - 08:59 PM

Dear Mahmoud,

I presume you are referring to section 8 of iso 22000.

Firstly, I recommend you to obtain iso 22004. This contains a large section expanding and explaining section8 of iso 22000.

I am not myself a user of iso 22000 but it is clear that the VA/VE procedures, monitoring etc will need to cover the typical HACCP requirements (or, more accurately, the iso-modified HACCP) plus the additional (MS) part which I guess is aligned in many ways to the ISO 9001 standard (see the comparative table at end of standard iso 22000.)

The items you mention in previous post do cover some of the VE requirements if that was your (unstated) question but are not yet, i think, fully comprehensive, eg I see no mention of calibration. Further requirements are given in 22004.

There are also very likely some other discussions on this subject in this forum, try searching within the iso 22000 forum.

This thread gives some detailed auditorial info but mainly prior to section 8

http://www.ifsqn.com...showtopic=12895

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#4 Mahmoud.S

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Posted 10 November 2009 - 03:13 PM

Dear Mahmoud,

I presume you are referring to section 8 of iso 22000.

Firstly, I recommend you to obtain iso 22004. This contains a large section expanding and explaining section8 of iso 22000.

I am not myself a user of iso 22000 but it is clear that the VA/VE procedures, monitoring etc will need to cover the typical HACCP requirements (or, more accurately, the iso-modified HACCP) plus the additional (MS) part which I guess is aligned in many ways to the ISO 9001 standard (see the comparative table at end of standard iso 22000.)

The items you mention in previous post do cover some of the VE requirements if that was your (unstated) question but are not yet, i think, fully comprehensive, eg I see no mention of calibration. Further requirements are given in 22004.

There are also very likely some other discussions on this subject in this forum, try searching within the iso 22000 forum.

This thread gives some detailed auditorial info but mainly prior to section 8

http://www.ifsqn.com...showtopic=12895

Rgds / Charles.C


Thank you Charles :)
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#5 Zeeshan

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Posted 11 November 2009 - 09:29 AM

Dear Mahmoud,


As I understand from your question, you have asked whether there are requirements in ISO 22K to have records of validation and verification activities.

I hope you understand that terms validation and verification are not interchangeable. Now comes to your question: The answer is "Partially Yes". There is requirement of having record(s) of verification activities (Ref. 7.8 of ISO 22K) but AFAIK there is no straightforward requirement of having record of validation activities in ISO 22K.

However it is a good practice to make and keep validation records as it helps you in future validation and re-validation activities and it also helps you to show the auditor how you had performed validation and what were the results.

Verification Plan is a document; it only guides you about method, frequency and responsibilities of verification activities. The results of activities (that is records) are some thing entirely different.

BTW, there is another relevant thread you should go through::

http://www.ifsqn.com...hl=verification

Added:: It seems you have copy-paste your verification plan from a file of Word or Excel. Due to which it looks some messy. It will be useful or helpful for members if you attach or upload that file here.


Regards:

Zeeshan
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#6 bennii

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Posted 12 November 2009 - 10:06 PM

Hi, there

There is a resource that can be purchased from ISO:

http://www.iso.org/i.../checklists.htm

The booklet itself is a bit weak in terms of guidance much like ISO 22004, because it wa both written too soon, especially if one has ISO 9004 expectations, but the CD-rom which is much like a 22K audit, with recommenations has been a great help.

I excerpted the Validation and Verification in 22K context

Bennii

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