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FSSC 22000 V 5.1 Clause 2.5.12 PRP Verification Interpretation

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Shere- Dean

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Posted 22 March 2021 - 10:04 PM

Good day, can someone provide clarification on the new FSSC 22000 V 5.1 clause, 2.5.12 PRP Verification (for food chain category C). Does anyone have a risk assessment they are willing to share or provide a link etc that can help with interpreting this clause?

How are you meeting the new requirement at your organization? Thanks in advance!



jdpaul

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Posted 24 March 2021 - 01:44 PM

Do you have the PRP technical standard scheme 22001-2? The easiest thing to do would be to make an audit checklist 

 

for instance, 

 

in the ISO 22001-2 PRP technical standard, you have the following PRPs

 

4 Construction and layout of buildings..................................................................................................4
5 Layout of premises and workspace ....................................................................................................5
6 Utilities – air, water, energy..................................................................................................................6
7 Waste disposal ......................................................................................................................................8
8 Equipment suitability, cleaning and maintenance.............................................................................9
9 Management of purchased materials ................................................................................................10
10 Measures for prevention of cross contamination............................................................................11
11 Cleaning and sanitizing ......................................................................................................................12
12 Pest control..........................................................................................................................................13
13 Personnel hygiene and employee facilities......................................................................................14
14 Rework..................................................................................................................................................16
15 Product recall procedures..................................................................................................................17
16 Warehousing........................................................................................................................................17
17 Product information/consumer awareness ......................................................................................18
18 Food defence, biovigilance and bioterrorism...................................................................................18
 
 
 
you would need to do this for all 18, but using as an example PRP 18 Food Defense, biovigilance and bioterrorism, I would have a checklist (made against the PRP 18 requirements) like below
 
  1. Have all sensitive areas been identified and secured or otherwise access controlled using locks, badge access, or other measures to restrict access to authorized personnel only? 
  2. Have acts of sabotage, vandalism, and terrorism that could affect sensitive processes or products been assessed and mitigated by protective controls?

you would answer those questions as such (compliant, not compliant (e.g., new sensitive area identified and not access restricted, etc.) And at the end of the entire verification audit you will probably want a summary of the results (e.g. what was found, what PRPs needs to be improved, etc.)

 

 

I am guessing you are doing something like this anyway since ISO 22000 basically requires the food safety team to review and verify PRPs (see section 8.2 in ISO 22000:2018)


Edited by jdpaul, 24 March 2021 - 01:52 PM.


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ToniAllardyce

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Posted 31 March 2021 - 05:21 PM

As the previous poster stated is create a checklist or do an annual reassessment to the individual point to the standard. In Canada theolder plants have the FSEP PRP's that had to have at minimum an annual reassessment done to ensure they were being implemented as it was written



Charles.C

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Posted 31 March 2021 - 07:43 PM

 

2.5.12 PRP VERIFICATION (FOOD CHAIN CATEGORIES C, D, G, I & K)

 For food chain categories C, D, G, I and K, the following additional requirement applies to ISO22000: 2018 clause 8.8.1:  
• The organization shall establish, implement and maintain routine (e.g. monthly)
site inspections/PRP checks to verify that the site (internal and external),
production environment and processing equipment are maintained in a suitable
condition to ensure food safety. The frequency and content of the site
inspections/PRP checks shall be based on risk with defined sampling criteria and
linked to the relevant technical specification.

 

A summary of above is  -

SECTION 2.5.12: Prerequisite Programmes Verification

A programme to verify PRPs must be established and maintained and shall be based on the risk assessment. The risk assessment must follow the defined criteria and technical specification and ensure product safety.

This requirement is applicable to the following food categories; C, D, E, F, I and K.

(https://ascconsultan...00-v5-1-changes)
ADDED - ABOVE INTERPRETATION MAY BE INACCURATE - SEE POST 5 ET SEQ

Seems that fssc's  additional "risk" clause is interpreted as applying to verification activities for  ALL the PRPs involved in following clause of iso22000 FSMS standard (WOW !!, Shades of a BRC-type philosophy) -

 

8.8.1The  organization  shall  establish,  implement  and  maintain  verification  activities.  The  verification planning shall define purpose, methods, frequencies and responsibilities for the verification activities.
The verification activities shall confirm that:
a)  the PRP(s) are implemented and effective;

 

However, as contemplated in previous Posts, there is no mandated  minimum frequency, eg an interval in range of 1month - 1year is theoretically acceptable if "based on risk".

 

JFI, Generally -

Verifying PRPs and CCPs
Many processors may understand that verification of CCPs and PRPs is essential to food safety, but there are others who simply do not fully comprehend how this should be done. There are four major types of verification activities:

• A non-audit review of documents. An example is reviewing CCP records to ensure that a specific lot of product complies with the HACCP plan.

• Conducting various measurements and assessment activities to ensure a PRP or the product is operating within defined parameters. An example is to collect environmental microbial swabs to ensure that the cleaning and sanitizing program is compliant with internal specifications, and to measure the microbial parameters of products.

• Conducting various assessments to determine if other components of the FSMS are operating within defined parameters. Examples include determining if training is effective, conducting mock recalls or ensuring that measurement equipment is properly calibrated.

Internal and external audits. The function of audits is to provide an unbiased assessment of the FSMS.4510ProcessControlTable3(1).jpg
The first step is in developing a verification program is to determine all of the processes that need to be verified (see Table 2). Next, a verification plan needs to be developed for each part of the FSMS. Table 3 provides an example of part of a verification plan.

(https://www.food-saf...orking#Sidebar1)
(The iso interpretation of verification is also detailed/exampled at considerable length in iso22004)

Attached File  Table2.PNG   231.74KB   11 downloads

 

Just as an illustration, some "Verification Activities" in Table 3 above  are exampled below for a Dairy Process/iso22002-1 -

Attached File  Verification Activities, iso22002-1.pdf   157.4KB   1495 downloads

 

It seemed to me that, if "risk" is applied to all 18 sections (and subs?) in Post 2, the effort involved may not be negligible.

Maybe simpler to generate a Verification H/M/L Global Risk Assessment (eg ranging 3/6/12 months) over the various Sections of iso22000 including Section 8. Or perhaps a retrospective risk analysis approach  as previously exampled on this forum. This utilises a semi-generic template which could be repeated or cross-linked to a batch of relevant frequencies, etc, eg see the (BRC) examples/cross-references in this short thread -

 

https://www.ifsqn.co...nts/#entry58503


Edited by Charles.C, 05 April 2021 - 06:27 PM.
edited/corrected (see BLUE above)

Kind Regards,

 

Charles.C


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Koko LMQ

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Posted 04 April 2021 - 12:22 AM

Just a simple "site / infrastructure inspection checklist" with criteria for checking, e.g. building, floor etc. and ensure the criteria met the ISO/TS 22002-X. It is required by GFSI Benchmarking Requirement, not all PRPs in ISO/TS 22002-x.



Charles.C

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Posted 04 April 2021 - 06:18 PM

Just a simple "site / infrastructure inspection checklist" with criteria for checking, e.g. building, floor etc. and ensure the criteria met the ISO/TS 22002-X. It is required by GFSI Benchmarking Requirement, not all PRPs in ISO/TS 22002-x.

 

Hi Koko,

 

Thanks input. 

 

Re ^^^(red). I hope you are correct. However the clause 2.5.12 specifically states "additional requirement applies to ISO22000: 2018 clause 8.8.1" and I observed that my 2nd quote above in Post 4 seemed to have  interpreted "risk' as being required for all  PRPs.

 

IMO the "applies to" text in clause 2.5.12 is ambiguous. The original text in GFSI (somewhere?) which presumably forced this addendum may clarify the intention.

 

PS - IMHO, it would have been advantageous for users if fssc had revised clause 8.8.1 rather than to just keep throwing in all these addenda but they don't own iso22000 of course. :smile:


Kind Regards,

 

Charles.C


Koko LMQ

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Posted 05 April 2021 - 08:21 AM

Hi Charles C.

Here it is GFSI requirement. Risk can be assessed by product type or production zone, e.g. high risk/high care area should be checked more frequent.

Best regards,
KOKO_LMQ


Edited by Koko LMQ, 05 April 2021 - 08:22 AM.


Charles.C

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Posted 05 April 2021 - 08:44 AM

Hi Charles C.

Here it is GFSI requirement. Risk can be assessed by product type or production zone, e.g. high risk/high care area should be checked more frequent.

Best regards,
KOKO_LMQ

 

Hi Koko,

 

Thks but I'm not too sure of the relevance of yr comment ?.

 

Can you post the relevant (to PRP Verification issue) GFSI text or provide a link ?


Kind Regards,

 

Charles.C


Koko LMQ

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Posted 05 April 2021 - 01:28 PM

Hi Charlies,

 

Here it is "GMP 10 - Site inspections / checks : A programme of site inspections / checks shall be established, implemented and maintained to ensure the site environment and processing equipment are maintained in a suitable condition to ensure food safety, as applicable to the activity of the site."

KOKO_LMQ

Attached Files


Edited by Koko LMQ, 05 April 2021 - 01:33 PM.


Koko LMQ

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Posted 05 April 2021 - 01:32 PM

Hi Charles,

You can see the self-assessment checklist from FSSC/GFSI - GMP 10.

KOKO

Attached Files



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Charles.C

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Posted 05 April 2021 - 03:48 PM

Hi Koko,

 

Thks yr attachment, etc. I deduce the pdf is sourced from FSSC, not GFSI.

 

I am still assimilating the info provided however my initial reaction is that FSSC's Verification "risk-related " content  is not a GFSI  requirement per se  (ie not a specific GFSI benchmark requirement). It appears to be "inspired" by FSSC themselves.

 

I was also rather intrigued by the GFSI comment - <<< Included in draft V5.1 as additional requirement to internal audits >>>

(I deduce that the item listed as "GMP 10" was introduced in GFSI's benchmarking requirements ver. 2020 and did not exist in FSSC22000 version 5)

 

PS - afaik, this is a "typical" GFSI 2020 benchmark compilation (as per yr Post 9) -

 

Attached File  9-Benchmarking_Requirements_v2020_Part3_c1.pdf   229.93KB   731 downloads


Edited by Charles.C, 05 April 2021 - 06:43 PM.
added

Kind Regards,

 

Charles.C


Charles.C

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Posted 05 April 2021 - 06:46 PM

Hi Koko,

 

I think I agree with the basic interpretations in yr Posts 5, 7 (Except for the owner of the risk-related text :smile: ) .

Thks again.


Kind Regards,

 

Charles.C


Koko LMQ

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Posted 06 April 2021 - 01:38 AM

Hi Koko,

 

I think I agree with the basic interpretations in yr Posts 5, 7 (Except for the owner of the risk-related text :smile: ) .

Thks again.

 

Dear Charles,

 

All attachments sourced from GFSI public comment made to FSSC benchmarking with GFSI requirements. Correct, additional "risk based", came from FSSC 2000. But the point I comment is the site inspection or fabrication inspection, not all PRPs as in ISO/TS 22002-1.Risk based should be made like, more frequent in High Risk or High Care area or open product areas (like BRCGS Food Issue 8).

KOKO



Charles.C

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Posted 06 April 2021 - 02:22 AM

Hi Koko,

 

TBH I don't really understand why GMP 10 was added by GFSI since it seems to me that it's content is already adequately covered within the existing GMPs listed by GFSI (ie within iso22002-1).

Similarly I consider that FSSC's further addition of a, one-off, risk based, checking frequency was equally redundant. It might have made fractionally more sense IMO if it was required for all the PRPs.

 

Even BRC who are surely the GFSI's King of Risk-based Requirers don't require the above for any PRPs. (although BRC instead  do require Validation unlike afaik everybody else)(SQF used to want it but finally gave up after avalanching auditorial confusions).

 

Maybe GFSI/FSSC are simply running out of things to revise.


Kind Regards,

 

Charles.C


Z Chemist

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Posted 08 April 2021 - 08:35 PM

Hi, 

 

Currently I do a verification every 3 month but I noticed the standard stated "for example monthly"? Is it that the auditor may be looking for a monthly verification?



Charles.C

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Posted 09 April 2021 - 01:15 AM

Hi, 

 

Currently I do a verification every 3 month but I noticed the standard stated "for example monthly"? Is it that the auditor may be looking for a monthly verification?

See Post 13, last sentence.


Kind Regards,

 

Charles.C


Shere- Dean

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Posted 24 June 2021 - 01:49 PM

Thanks for sharing everyone! 



Dorota1981

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Posted 27 December 2021 - 11:38 AM

I have a request, if any of you can send me a sample procedure for point 2.5.1.b and a sample form or instruction for 2.5.1 d)



manalo_jose

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Posted 16 July 2022 - 04:39 AM

Can someone explain how defined sampling criteria means on the PRP Verification? 



Tony-C

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Posted 17 July 2022 - 06:02 AM

Can someone explain how defined sampling criteria means on the PRP Verification? 

 

Hi manalo_jose,

 

The sampling criteria will be based on the PRP, quite a few can be carried out by inspection of the facility, for example requirements in TS/ISO 22002-1 for:

Section 4 requirements for Construction and layout of buildings

Section 5 requirements for Layout of premises and workspace

 

Some can be checked by inspection and review of paperwork, for example:

Section 7 requirements for Waste disposal

Section 12 requirements for Pest Control

 

Some can be checked by inspection, review of paperwork, product analysis and environmental monitoring, for example:

Section 11 requirements for Cleaning and sanitizing

 

Kind regards,

 

Tony



Charles.C

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Posted 17 July 2022 - 12:26 PM

Hi manalo_jose,

 

The sampling criteria will be based on the PRP, quite a few can be carried out by inspection of the facility, for example requirements in TS/ISO 22002-1 for:

Section 4 requirements for Construction and layout of buildings

Section 5 requirements for Layout of premises and workspace

 

Some can be checked by inspection and review of paperwork, for example:

Section 7 requirements for Waste disposal

Section 12 requirements for Pest Control

 

Some can be checked by inspection, review of paperwork, product analysis and environmental monitoring, for example:

Section 11 requirements for Cleaning and sanitizing

 

Kind regards,

 

Tony

Hi Tony,

 

As I understand the above, I think yr interpretation may be contrary to that proposed/discussed  in previous posts in this thread, eg Post 5 et seq


Kind Regards,

 

Charles.C


Charles.C

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Posted 17 July 2022 - 12:36 PM

Hi Tony,

 

JFI, as I understand the above, seems may be contrary to that proposed/discussed  in previous posts in this thread, eg Post 5 et seq  (ie "not all PRPs....x.")?


Kind Regards,

 

Charles.C


Tony-C

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Posted 18 July 2022 - 03:31 AM

Hi Tony,

 

As I understand the above, I think yr interpretation may be contrary to that proposed/discussed  in previous posts in this thread, eg Post 5 et seq

 

Hi Charles,

 

Inspections are important but cannot provide complete verification of all PRPs, see underlined text which requires documented evidence.

 

There are many examples but I’ll pick TECHNICAL ISO/TS SPECIFICATION 22002-1

Prerequisite programmes on food safety —Part 1: Food manufacturing

Section 12 Pest control

12.2 Pest control programmes

The establishment shall have a nominated person to manage pest control activities and/or deal with appointed expert contractors.

Pest management programmes shall be documented and shall identify target pests, and address plans, methods, schedules, control procedures and, where necessary, training requirements.

Programmes shall include a list of chemicals which are approved for use in specified areas of the establishment.

12.5 Monitoring and detection

A map of detectors and traps shall be maintained.

The results of inspections shall be analysed to identify trends.

12.6 Eradication

Eradication measures shall be put in place immediately after evidence of infestation is reported.

Pesticide use and application shall be restricted to trained operatives and shall be controlled to avoid product safety hazards.

Records of pesticide use shall be maintained to show the type, quantity and concentrations used; where, when and how applied, and the target pest.

 

Some requirements can be verified by inspection:

12.3 Preventing access

Buildings shall be maintained in good repair. Holes, drains and other potential pest access points shall be sealed.

External doors, windows or ventilation openings shall be designed to minimize the potential for entry of pests.

12.4 Harbourage and infestations

Storage practices shall be designed to minimize the availability of food and water to pests.

Potential pest harbourage (e.g. burrows, undergrowth, stored items) shall be removed.

Where outside space is used for storage, stored items shall be protected from weather or pest damage (e.g. bird droppings).

 

Kind regards,

Tony



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Charles.C

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Posted 18 July 2022 - 05:20 AM

Hi Tony,

 

Definitely not my area and this thread was a long time ago but I think the "difference" was more concerned with the basic  scope of this additional fssc22000 clause. (Particularly due the "unclarity" of fssc's text).

 

Post 5 indicated that a much truncated response was apparently (correctly or not) being auditorially accepted, eg the section 12/2002-1 items in Post 23 not required to be considered at all. As you can see in the posts subsequent to No.5 , the justifying logic was distinctly  tortuous.


Kind Regards,

 

Charles.C


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Posted 18 July 2022 - 06:43 AM

Hi Charles,

 

I note your comment regarding the scope of the additional clause. For sure 2.5.12 PRP VERIFICATION (FOOD CHAIN CATEGORIES C, D, G, I & K) was added to comply with the GFSI Benchmarking Requirements version 2020 GMP 10 for Site inspections/checks.

 

This additional requirement states for food chain categories C, D, G, I and K, the additional requirement applies to ISO22000: 2018 clause 8.8.1:

8.8 Verification related to PRPs and the hazard control plan

8.8.1 Verification

The organization shall establish, implement and maintain verification activities. The verification planning shall define purpose, methods, frequencies and responsibilities for the verification activities.

The verification activities shall confirm that:

a) the PRP(s) are implemented and effective;

 

My response to manalo_jose was regarding PRP Verification as required by the combined requirements of the FSSC 22000 Certification Scheme.

 

Kind regards,

Tony





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