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How to Validate SOPs and PRPs?


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#1 tiger

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Posted 10 September 2014 - 08:27 PM

Question #1: Do we need to validate ALL our SOPs or just PRPs? and how?

 

Question #2: How do we validate following PRPs?

  1. Construction and layout of building
  2. Layout of premises and workspace
  3. Utilities - air, water, energy
  4. Waste disposal
  5. Equipment suitability, cleaning and maintenance
  6. Management of purchased material
  7. Measures for prevention of cross contamination
  8. Cleaning and sanitizing
  9. Pest control
  10. Personnel hygiene and employee facilities
  11. Rework
  12. Product recall procedures
  13. Warehousing
  14. Product information
  15. Food defense, biovigilance and bioterrorism

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#2 Charles.C

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Posted 11 September 2014 - 02:46 AM

Dear Tiger,

 

IIRC, ISO22000, and i presume FSSC22000 also, does not require validation of PRPs. One might say that iso22002-1 has done it already.

But Verification is required by iso22000.

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#3 jel

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Posted 11 September 2014 - 01:57 PM

The PPR cleaning and sanitizing, and in some cases the services of air, water and energy, require validation.


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#4 Charles.C

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Posted 11 September 2014 - 03:03 PM

The PPR cleaning and sanitizing, and in some cases the services of air, water and energy, require validation.

Dear jel,

 

I think this aspect has come up before.

 

Can you reference anywhere in the FSSC standard (or iso22000) which mentions the necessity to validate PRPs ?

 

For   iso22000, I quote iso 22004, para. 8.1 -

 

Where  a control measure cannot be validated, it cannot be included within a haccp plan or in operational PRPs, but it can be applied within PRPs

 

But perhaps FSSC has an additional  requirement (don't use it myself) .?

 

Rgds / Charles.C

 

PS - I don't think "SOP", per se, exists in iso22000. fssc22000 :dunno:

 

In general, "SOP" can refer to almost anything of course. :smile:


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Charles.C


#5 RG3

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Posted 11 September 2014 - 03:39 PM

Question #1: Do we need to validate ALL our SOPs or just PRPs? and how? (Depends what GFSI audit scheme you're choosing) I know for SQF they've asked for this but in my past BRC audits they didn't. Maybe with the new version this may change. I would say SOP's are validated through your management review of your systems.

 

Question #2: How do we validate following PRPs? For the majority of these review 3 months or 4 months or 6 months worth of information and say I reviewed this document from this month to this month and have found __________.

  1. Construction and layout of building (Past history of what the building did before [wasn't a toxic waste dump], know what your neighbors do [they're not a toxic waste dump]) 
  2. Layout of premises and workspace (review the process and flow of WIP and FG's and waste during your Food Defense Review)
  3. Utilities - air, water, energy (Air = micro of Yeast and Mold [make a trend]) (Water = micro HPC and Coliforms) (Energy?)
  4. Waste disposal (During your GMP audit see if waste is being carried out in a timely manner)
  5. Equipment suitability, cleaning and maintenance (During your GMP audit)
  6. Management of purchased material (During the GMP audit you can choose certain RawMaterialCodes and see if they're approved)
  7. Measures for prevention of cross contamination (During your GMP audit)
  8. Cleaning and sanitizing (Pre-ops)
  9. Pest control (Pest control reports [Make a graph for each pest activity across the months]
  10. Personnel hygiene and employee facilities (During your GMP audit)(I've actually randomly swabbed hands for Coliform/E.Coli and Staph)
  11. Rework (Review the rework process during management review of your systems or choose to do a traceability test on a rework)
  12. Product recall procedures (Traceability Test/Mock Recall)
  13. Warehousing (GMP audit)
  14. Product information (Review your scope versus what is being produced versus your product specification)
  15. Food defense, biovigilance and bioterrorism (Your food defense annual review)

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#6 jel

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Posted 11 September 2014 - 04:36 PM

Dear jel,

 

I think this aspect has come up before.

 

Can you reference anywhere in the FSSC standard (or iso22000) which mentions the necessity to validate PRPs ?

 

For   iso22000, I quote iso 22004, para. 8.1 -

 

 

But perhaps FSSC has an additional  requirement (don't use it myself) .?

 

Rgds / Charles.C

 

PS - I don't think "SOP", per se, exists in iso22000. fssc22000 :dunno:

 

In general, "SOP" can refer to almost anything of course. :smile:

Dear Charles
 
I agree with you that nowhere in FSCC says that cleaning and sanitizing must be validated, or any other PPR should be validated; ISO 22000 speaks of that validation is only for control measures or combinations thereof. The problem is that there are many activities that if not done correctly the ability of the organization to generate safety foods couldn't be getting, and from my point of view cleanliness and sanitation is one of them.
 
If you're driving allergens, should you have full assurance that your cleaning process removes them, at least until its threshold?
 
The validation of any process, not just in the case of the food industry, is key to ensuring quality or safety in this case.
 
Validate a process is to have the full assurance that a process consistently do what is supposed to do, beyond any doubt.
 
A validated process is a robust process. And does the cleaning and sanitizing should not be a robust process?
 
An apology for my English.
 
Best regards

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#7 tiger

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Posted 11 September 2014 - 06:21 PM

Dear Tiger,

 

IIRC, ISO22000, and i presume FSSC22000 also, does not require validation of PRPs. One might say that iso22002-1 has done it already.

But Verification is required by iso22000.

 

Rgds / Charles.C

 

 

Charles, we just had ans inspector to perform our re-certification audit and he said that all out PRPs needs to have validation procedure....is there any specific section on the standard saying that we don't have top validate? 


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#8 Charles.C

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Posted 11 September 2014 - 06:47 PM

Charles, we just had ans inspector to perform our re-certification audit and he said that all out PRPs needs to have validation procedure....is there any specific section on the standard saying that we don't have top validate? 

Dear Tiger,

 

I presume yr query relates to iso22000/fssc22000 ?

 

As i noted above,  this question has come up before for iso22000 and generated some responses from users of the standard. IIRC the conclusion was verification only required.

 

I would have thought an auditor could readily show you the textual  requirement for validation if it exists. ?

 

Rgds / Charles.C

 

PS - @jel, I appreciate yr comments but as you probably know, many PRPs are not readily validated whereas verification is (relatively). It can also depend on the interpretation of Va/Ve terminologies. And pls note that iso22004 supercedes iso22000 in respect to implementation.

(strictly my comments refer iso22000 rather than fssc22000)

 

PPS - note that the requirement for PRP verification is stated in iso22000, para 7.2.3


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Charles.C


#9 tiger

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Posted 11 September 2014 - 07:11 PM

 

Question #1: Do we need to validate ALL our SOPs or just PRPs? and how? (Depends what GFSI audit scheme you're choosing) I know for SQF they've asked for this but in my past BRC audits they didn't. Maybe with the new version this may change. I would say SOP's are validated through your management review of your systems.

 

Question #2: How do we validate following PRPs? For the majority of these review 3 months or 4 months or 6 months worth of information and say I reviewed this document from this month to this month and have found __________.

  1. Construction and layout of building (Past history of what the building did before [wasn't a toxic waste dump], know what your neighbors do [they're not a toxic waste dump]) 
  2. Layout of premises and workspace (review the process and flow of WIP and FG's and waste during your Food Defense Review)
  3. Utilities - air, water, energy (Air = micro of Yeast and Mold [make a trend]) (Water = micro HPC and Coliforms) (Energy?)
  4. Waste disposal (During your GMP audit see if waste is being carried out in a timely manner)
  5. Equipment suitability, cleaning and maintenance (During your GMP audit)
  6. Management of purchased material (During the GMP audit you can choose certain RawMaterialCodes and see if they're approved)
  7. Measures for prevention of cross contamination (During your GMP audit)
  8. Cleaning and sanitizing (Pre-ops)
  9. Pest control (Pest control reports [Make a graph for each pest activity across the months]
  10. Personnel hygiene and employee facilities (During your GMP audit)(I've actually randomly swabbed hands for Coliform/E.Coli and Staph)
  11. Rework (Review the rework process during management review of your systems or choose to do a traceability test on a rework)
  12. Product recall procedures (Traceability Test/Mock Recall)
  13. Warehousing (GMP audit)
  14. Product information (Review your scope versus what is being produced versus your product specification)
  15. Food defense, biovigilance and bioterrorism (Your food defense annual review)

 

Thank you sooooo much :) 


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#10 Charles.C

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Posted 11 September 2014 - 07:30 PM

Dear Tiger,

 

This attachment should clarify the PRP requirements (for iso22000) -

 

Attached File  ISO_22000_series_Pauline_Jones.ppt   1.44MB   289 downloads

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#11 tiger

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Posted 11 September 2014 - 10:57 PM

Dear Tiger,

 

This attachment should clarify the PRP requirements (for iso22000) -

 

attachicon.gifISO_22000_series_Pauline_Jones.ppt

 

Rgds / Charles.C

 

Thank you Charles


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#12 RG3

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Posted 12 September 2014 - 08:45 PM

PR

Pre-requisite Control

Procedures/Policies

Method of Validation

Validated by

Date of Validation

Result of Validation

1

Personnel Practices GMP's

  • Personal Hygiene procedure (3.001)
  • GMP standards (3.002)
  • Hand swabbing procedure (2.032)
  • Blood spillage procedure (2.025)
  • Visitor questionaire (2.039)

1. Daily Pre-Operational Inspection reports collectively address Personnel Practices. Quality Assistant visually verifies that at the beginning of the shift employees entering the processing room wash their hands and boots.  Quality Assistant also visually verifies  all employees are wearing proper attire face mask, hair net coverall plastic disposable white apron, and disposable gloves.  Depending on job some employees are required to use stainless steel gloves.  Processing plant personnel are not wearing any jewelry or any nail polish.  No evidence of repeat non-conformances on major deficiencies in the program. 2. Monthly laboratory testing are performed on the hands of ramdom employees.

RG3

9/12/14

Laboratory test results were reviewed from January 2014 to March 2014 by Quality Manager.  On two occations results were above normal and a corrective action of retraining and retesting the employees hand was performed on the employee with the results above normal.  The result for laboratory retesting was satisfactory on employee #2.  Going forward the new procedure is to retest anyone with a result out of normal range.

2

Training Controls

  • Training Policy (1.017)
  • CCP Training procedure (2.044)

GFSI required training topics are defined in Employee Training Register, training is according to the employee's job activities and responsibilities along with job skill related topics. 1. Direct observation of CCP monitoring is designed as a routine verification activity. Direct observation validates effectiveness of CCP training systems. 2. Daily Pre-Operational Inspection report performance validates effectiveness of GMP and SSOP training.    Records are observed for a period of 6 months. No evidence of repeat minor non-conformances or major deficiencies in the program can occur for the prerequisite program to be considered valid.

RG3

9/12/14

80% of the scheduled GFSI training topics in year 2014 are completed. Training program is considered effective. Employees from various departments were randomly selected and interviewed to evaluate the effectiveness of training on the following topics- QC Inspections, Receiving Truck Inspection, and Product Identification. All employee were able to respond correctly to the survey questions. Daily CCP direct observation and verification results confirm the effectiveness of CCP training.


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#13 RG3

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Posted 12 September 2014 - 08:46 PM

Wait...I don't like how it reformatted from the tables from word. How do I attach a word document?


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#14 Charles.C

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Posted 13 September 2014 - 12:10 AM

Wait...I don't like how it reformatted from the tables from word. How do I attach a word document?

 

(1) click "more reply options" under the "post" box

 

(2) for method attachment (if not obvious) see -

 

> help (top page) > posting > attachments

 

Rgds / Charles.C


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#15 food safety 101

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Posted 29 December 2014 - 09:13 PM

Can you please specify a little more on how to validate PRP's 14- Product Rework  & 17- Product Information and Product Awareness Product Information and Product Awareness.? Maybe an example of how it was carried out at your manufacturing company would be greatly appreciated. 

 

thank you


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#16 Charles.C

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Posted 30 December 2014 - 05:48 AM

Can you please specify a little more on how to validate PRP's 14- Product Rework  & 17- Product Information and Product Awareness Product Information and Product Awareness.? Maybe an example of how it was carried out at your manufacturing company would be greatly appreciated. 

 

thank you

 

Dear FS101,

 

i assumed yr query was to SQF Food. Post moved accordingly. Pls confirm if otherwise.

 

Rgds / Charles.C


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#17 jel

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Posted 30 December 2014 - 02:03 PM

Can you please specify a little more on how to validate PRP's 14- Product Rework  & 17- Product Information and Product Awareness Product Information and Product Awareness.? Maybe an example of how it was carried out at your manufacturing company would be greatly appreciated. 

 

thank you

You don'n need to validate PRP's; you only need to validate oPRP' and CCP (ISO 22000)


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#18 Charles.C

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Posted 30 December 2014 - 02:16 PM

You don'n need to validate PRP's; you only need to validate oPRP' and CCP (ISO 22000)

 

Dear jel,

 

this is SQF, not fssc. (at least afaik)

 

But thanks anyway. :smile:

 

Rgds / Charles.C


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#19 jel

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Posted 30 December 2014 - 02:35 PM

Dear jel,

 

this is SQF, not fssc. (at least afaik)

 

But thanks anyway. :smile:

 

Rgds / Charles.C

Dear Charles

I guess the question is for FSCC 22000, because PRP's 14 Product Rework and 17 Product Information and Product awareness belong to ISO/TS 22002-1

Regards


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#20 Charles.C

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Posted 30 December 2014 - 02:45 PM

Dear Charles

I guess the question is for FSCC 22000, because PRP's 14 Product Rework and 17 Product Information and Product awareness belong to ISO/TS 22002-1

Regards

 

Dear jel,

 

I bow to yr investigative power ! :thumbup:

(I had randomly guessed the 14 / 17 were SQF refs [somewhere])

 

If you are correct, i agree with yr post.

 

Hopefully FS 101 will respond sometime in the near future.

 

Rgds / Charles.C


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#21 food safety 101

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Posted 30 December 2014 - 09:17 PM

For the FSSC 22000 can anyone please specify a little more on how to validate PRP's 14- Product Rework  & 17- Product Information and Product Awareness Product Information and Product Awareness.? Maybe an example of how it was carried out at your manufacturing company would be greatly appreciated. 


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#22 Charles.C

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Posted 31 December 2014 - 03:42 AM

Dear FS 101,

 

Thank you for the confirmation.

 

For other readers, I note that for some reason, the OP renumbered his list of PRPs so as to start from unity. :smile:

 

Rgds / Charles.C

 

PS - So the answer, afaik / as above, to yr query is "You don't".


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#23 food safety 101

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Posted 31 December 2014 - 04:48 PM

Thanks everyone for your comments,

 

Dear Charles can you please post the FSSC renumbered list?

 

Jel, we do need to validate the PRPs and it's very easy to do none the less. For most PRPs all we have to do to validate them is conduct an internal monthly GMP audit, for the rest we would need to create and carry out an annual food defense audit.

 

The only ones I'm having trouble validating are the PRPs that had to deal with Product rework and Product awareness 


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#24 Charles.C

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Posted 31 December 2014 - 07:54 PM

Dear FS101,

 

The FSSC list of Prerequisites for food is given in iso22002-1. AFAIK, the latest ed.is 2009.

The wording/order/total number of items  listed in post #1 is closely similar to that in iso22002-1 (2009).

But the iso list starts numbering from No.4 whereas the list in post #1 starts numbering from No.1, ie iso item No.4 = Post1, item No.1 and ending with iso, item No.18 = Post1, item No.15.

 

The numbers/titles in your post #21 look to be approx. matched to those in the iso list (eg iso #17 is “Product information/consumer awareness”), ie yr numbers are aligned with respect to iso22002-1.

 

The interpretation/distinction of validation/verification is a much disputed topic. The brief defs in iso22000 are elaborated in considerable detail in iso22004 (2005)(latest ed. is ca 2013 which unseen by me).

For a probably authoritative viewpoint on the necessity of validation for PRPs in iso22000, see post #10.

Based on iso22004 (2005), I suggest that the activities mentioned in yr previous post might relate to  verification.

 

Rgds / Charles.C


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#25 hilda anwar

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Posted 21 January 2015 - 11:05 AM

hi tiger,

 

i think if you want to do validation, you should check pharmaceutical requirement.

because in food, especially in iso 22000, its clearly mention that it just need verification.

 

i'm also curious about this validation in food manufacturing,

because for high risk product, i think we also need validation


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