Jump to content

  • Quick Navigation
Photo
- - - - -

Interpretation of Validation/Verification


  • You cannot start a new topic
  • Please log in to reply
23 replies to this topic

#1 Owen

Owen

    Grade - Active

  • IFSQN Active
  • 2 posts
  • 0 thanks
0
Neutral

Posted 08 February 2011 - 11:00 PM

Hello Everyone,
I am new to the forum. I am a Management Systems professional involved in Quality and Food Safety Implementation. I recently changed jobs and I am currently responsible for implementing SQF Code 2000 Level 2.

I ran head on into the Validation/Verification Monster.

This is my understanding

1 The right results are obtained (Validation) To include initial validation and re-validation where necessary.

2 Things are done right. (Monitoring) Which involves but not limited to the use of forms to collect data.

3. The right things are done. (Validation/Verification) Now here is where the problem exists and I would like help to clarify. How I did it previously very simply is to have the operators/ whomever is responsible for the operation sign off on the process they are responsible for (Validation) and then have someone who out ranks them sign to sat I checked and it was done(Verification). Now this is how I validate and verify my production and other processes?

4 The there is the process of testing the process or equipment periodically to ensure that the intended results are obtained. eq Microbe testing, calibration etc.
(Verification)

Can some-one help me with my own interpretation of this.
Thanks
Owen



#2 George @ Safefood 360°

George @ Safefood 360°

    Grade - SIFSQN

  • Corporate Sponsor
  • 374 posts
  • 317 thanks
23
Excellent

  • United States
    United States
  • Gender:Male
  • Location:Ireland and USA

Posted 09 February 2011 - 01:08 AM

Hi Owen

Welcome to the forum.

There is much confusion about the meaning and use of these terms when applied to food safety management. They are often used interchangeably to describe the same function or activity. Global Standards and codes of practice use them with an assumption that the user already has a clear understanding of their meaning – which is not always the case. I have also experienced third party auditors who displayed a poor understanding of the two terms (although less so in recent years).

I must admit I am also a veteran of the mental twists and turns required to pin-down exactly what Verification and Validation mean when applied to quality and food safety. To gain a clear insight it is helpful to apply them to a real food safety scenario…

Let’s take, for example, the following:

· A food company producing a cooked meat product.

· Their Hazard Analysis has identified Salmonella spp. as a hazard.

· The company cooks the meat to a minimum temperature of 70oC for a minimum 2 minutes.

· This is a CCP and is applied to reduce the risk to an acceptable level.

· The company now sets up a monitoring plan to check the core temperature of the meat every 10 minutes during the cooking process using a temperature probe. It is the Cooker Operator’s responsibility to check and record the temperature / time is to specification.

Now applied to the above we may define Verification and Validation as follows:

VERIFICATION: This is the action of checking that what we say we are doing - we are in fact doing! i.e. the operator is checking the temperature / time every 10 minutes according to the HACCP plan and recording the result. We are simply ‘verifying’ that the requirements of the plan are being met.

VALIDATION: This is confirming (or proving) that what we are doing is in fact capable of reducing the hazard to an acceptable level. In other words ‘Is cooking the meat to 70oC for 2 minutes sufficient to kill Salmonella?’

So we are answering two separate questions: 1) Are we doing what we say? (Verification) and 2) Is what we’re doing adequate? (Validation).

Verification activities include sign-off of records by a Supervisor/Manager, internal auditing, calibration etc.

Validation activities include challenge testing, shelf-life testing, reference to reputable standards, research papers, legislation, codes of practice etc.

The above, from my experience, is a good example and is generally accepted by auditors – I hope it provides some clarification.



G Howlett

#3 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 17,360 posts
  • 4836 thanks
943
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 09 February 2011 - 03:21 AM

Dear Owen,

Actually the HACCP food viewpoint has somewhat simplified the subject in recent times IMO compared to the reams of philosophical arguments one used to see. There is a very nice Codex document on validation (which tends to be the more problematical half of the pair in my opinion) which was developed for food and can be found in various places on this forum (see below).

For food, there is currently a chronological factor which is considered notionally decisive for separating the 2 items. Validation comes before implementation, verification comes after. So the activities included within Validation tend to be a mixture of theoretical (eg finding references to other people’s demonstrations of justification of specific critical limits for safety related procedures) and practical (doing trial runs to show that one’s system does work with the proposed critical limits, eg a required bacteriological kill ratio is achieved using reference values). Similarly Verification tends to involve subsequent routine operational activities associated with establishing confidence that the intended (safety) result is maintained (eg calibration aspects, confirming accuracy of records, carrying out end-product micro. analyses, swabbing-analysing equipment / hands, studying industrial rejection data / current research output).

If you look at other disciplines, one can find a large array of (often staged) interpretations, some very precisely defined as to how they are utilised, eg pharmaceuticals industry. Additionally for food, the Americans tend to position validation as a subset of verification often unlike the Europeans (but not, predictably, the Irish I believe.)

I also predict that someone will shortly disagree with some of the above. :biggrin:

Rgds / Charles.C

PS, if you can lay your hands on a copy of ISO 22004, this contains a beautiful (IMO) extended exposition of the practical interpretation / implementation of Va/Ve.

PPS here is a nice article on subject, ref4 is codex doc. referred above and also uploaded below (the "G" in GFS is a typo :oops: ).

Attached File  Validation, 2009,Food Safety Magazine.pdf   100.5KB   298 downloads
Attached File  Codex, guidelines for validation of GFS control measures.pdf   170.26KB   215 downloads


Kind Regards,

 

Charles.C


Thanked by 1 Member:

#4 GMO

GMO

    Grade - FIFSQN

  • IFSQN Fellow
  • 2,694 posts
  • 686 thanks
176
Excellent

  • United Kingdom
    United Kingdom

Posted 09 February 2011 - 09:24 AM

Here's my interpretation of the terms:

Validation: Can it be safe? I.e., in theory can it work to make safe food? Think about this as something you would think about before you even had a food processing facility. This is the "designing food safety into the process" stage. This includes why you choose the critical limits for monitoring.

Monitoring: Are checks reaching targets? If you think about monitoring as being ideally continuous it's the checks you would do to ensure the food is safe before you send it out the door.

Verification: Are independent checks showing safe food is being made? These aren't necessarily checks at the time you're releasing the food and aren't necessarily designed into the process but they're independent checks of the monitoring to ensure that the validation and monitoring are effective.

So it's kinda:

Validation: Can it be safe?
Monitoring: Is it hitting target?
Verification: Is it safe?

So if you cook a chicken your validation will be around your choice of temperature and whether your oven can achieve the 6 log reduction you want. It will include literature references, and probably trial work. Your monitoring might be exit core temperature and your verification would be micro testing, audits, complaints etc.



Thanked by 4 Members:

#5 Owen

Owen

    Grade - Active

  • IFSQN Active
  • 2 posts
  • 0 thanks
0
Neutral

Posted 09 February 2011 - 02:52 PM

Thanks everyone for your thoughtful insight into the matter. Very great stuff.
Owen



#6 George @ Safefood 360°

George @ Safefood 360°

    Grade - SIFSQN

  • Corporate Sponsor
  • 374 posts
  • 317 thanks
23
Excellent

  • United States
    United States
  • Gender:Male
  • Location:Ireland and USA

Posted 10 February 2011 - 02:34 PM

Hi Owen

I have attached a copy of the Dutch HACCP Standard. On pages 27 & 28 you will find some excellent explainations and examples of validation and verification activities. I have found it of value when implementing food safety systems.

G Howlett

Attached Files



Thanked by 2 Members:

#7 SS2010

SS2010

    Grade - MIFSQN

  • IFSQN Member
  • 65 posts
  • 7 thanks
0
Neutral

  • Australia
    Australia

Posted 15 February 2011 - 12:40 AM

Wooooooooow ,

Many thanks....

Can you suggest me any reference for the different microorganisms activity at different situation ,and what is the ideal requirement to inactivate or killing them...

i want to start risk assessment but m not in touch with my microbiology touch from such a long period of time...

thansk in advanceee
Hi Owen

Welcome to the forum.

There is much confusion about the meaning and use of these terms when applied to food safety management. They are often used interchangeably to describe the same function or activity. Global Standards and codes of practice use them with an assumption that the user already has a clear understanding of their meaning – which is not always the case. I have also experienced third party auditors who displayed a poor understanding of the two terms (although less so in recent years).

I must admit I am also a veteran of the mental twists and turns required to pin-down exactly what Verification and Validation mean when applied to quality and food safety. To gain a clear insight it is helpful to apply them to a real food safety scenario…

Let’s take, for example, the following:

· A food company producing a cooked meat product.

· Their Hazard Analysis has identified Salmonella spp. as a hazard.

· The company cooks the meat to a minimum temperature of 70oC for a minimum 2 minutes.

· This is a CCP and is applied to reduce the risk to an acceptable level.

· The company now sets up a monitoring plan to check the core temperature of the meat every 10 minutes during the cooking process using a temperature probe. It is the Cooker Operator’s responsibility to check and record the temperature / time is to specification.

Now applied to the above we may define Verification and Validation as follows:

VERIFICATION: This is the action of checking that what we say we are doing - we are in fact doing! i.e. the operator is checking the temperature / time every 10 minutes according to the HACCP plan and recording the result. We are simply ‘verifying’ that the requirements of the plan are being met.

VALIDATION: This is confirming (or proving) that what we are doing is in fact capable of reducing the hazard to an acceptable level. In other words ‘Is cooking the meat to 70oC for 2 minutes sufficient to kill Salmonella?’

So we are answering two separate questions: 1) Are we doing what we say? (Verification) and 2) Is what we’re doing adequate? (Validation).

Verification activities include sign-off of records by a Supervisor/Manager, internal auditing, calibration etc.

Validation activities include challenge testing, shelf-life testing, reference to reputable standards, research papers, legislation, codes of practice etc.

The above, from my experience, is a good example and is generally accepted by auditors – I hope it provides some clarification.



G Howlett
[/quote]



#8 George @ Safefood 360°

George @ Safefood 360°

    Grade - SIFSQN

  • Corporate Sponsor
  • 374 posts
  • 317 thanks
23
Excellent

  • United States
    United States
  • Gender:Male
  • Location:Ireland and USA

Posted 17 February 2011 - 12:28 AM

I’d suggest you start with these… they are both reliable sources and easy to use.

The FDA’s Bad Bug Book:

http://www.fda.gov/Food/FoodSafety/FoodborneIllness/FoodborneIllnessFoodbornePathogensNaturalToxins/BadBugBook/default.htm

New Zealand Food Safety Authority’s pathogen datasheets:

http://www.foodsafety.govt.nz/science/other-documents/data-sheets/



George Howlett

Thanked by 2 Members:

#9 QANewHopeMills

QANewHopeMills

    Grade - Active

  • IFSQN Active
  • 11 posts
  • 3 thanks
0
Neutral

  • United States
    United States

Posted 07 April 2011 - 08:29 PM

Hello Everyone,
I am new to the forum. I am a Management Systems professional involved in Quality and Food Safety Implementation. I recently changed jobs and I am currently responsible for implementing SQF Code 2000 Level 2.

I ran head on into the Validation/Verification Monster.

This is my understanding

1 The right results are obtained (Validation) To include initial validation and re-validation where necessary.

2 Things are done right. (Monitoring) Which involves but not limited to the use of forms to collect data.

3. The right things are done. (Validation/Verification) Now here is where the problem exists and I would like help to clarify. How I did it previously very simply is to have the operators/ whomever is responsible for the operation sign off on the process they are responsible for (Validation) and then have someone who out ranks them sign to sat I checked and it was done(Verification). Now this is how I validate and verify my production and other processes?

4 The there is the process of testing the process or equipment periodically to ensure that the intended results are obtained. eq Microbe testing, calibration etc.
(Verification)

Can some-one help me with my own interpretation of this.
Thanks
Owen


Owen, you're not alone when it comes to being confused about verification and validation.
My understanding of verification is saying what you'll do and then doing what you say. This is recorded in the form of an operator signing/initialing and dating a monitoring record of some type. Also the supervisor or a line leader can also sign/initial and date that they have monitored the operator monitoring activity. This is verification.
Validating a system, such as a pre-requisite program, is providing evidence that the control program is operating effectively. This can be done by a review or analysis of the (verification) monitoring records and other records that would support the controls you're validating. Other records could include customer complaints regarding foreign objects, or rather the absence of customer complaints regarding the absence of foreign objects. Thus this provides additional supportive data towards validating your control program. This review is usually done by the Food Safety team who must agree on whether the records prove that the program is effective or not. The minutes of this meeting can be written up as a review to document the teams conclusion. You can also validate a control program by third party (certified labs) analysis such as microbiological testing of water or allergen analysis of finished products. The microbial testing you're doing can be compiled for a couple of months then have the team review the findings. If the finding reveal a positive trend of effectively controling the hazard then you can consider the control program validated.

Good luck and don't be afraid to ask more questions.
Trace

#10 GMO

GMO

    Grade - FIFSQN

  • IFSQN Fellow
  • 2,694 posts
  • 686 thanks
176
Excellent

  • United Kingdom
    United Kingdom

Posted 08 April 2011 - 06:45 AM

Validating a system, such as a pre-requisite program, is providing evidence that the control program is operating effectively. This can be done by a review or analysis of the (verification) monitoring records and other records that would support the controls you're validating. Other records could include customer complaints regarding foreign objects, or rather the absence of customer complaints regarding the absence of foreign objects. Thus this provides additional supportive data towards validating your control program. This review is usually done by the Food Safety team who must agree on whether the records prove that the program is effective or not. The minutes of this meeting can be written up as a review to document the teams conclusion. You can also validate a control program by third party (certified labs) analysis such as microbiological testing of water or allergen analysis of finished products. The microbial testing you're doing can be compiled for a couple of months then have the team review the findings. If the finding reveal a positive trend of effectively controling the hazard then you can consider the control program validated.

Good luck and don't be afraid to ask more questions.
Trace



No, this is verification still. Think about validation as something you would do before you make a single product (some possibly can be done as a result of trials). As you can see, what you suggest is not possible if you've not started production. Validation is about whether the controls can be effective. For example, cooking a chicken, the core temperature you use should be based upon solid scientific evidence of the temperature at which vegetative pathogens such as Listeria, Salmonellae and Campylobacter are killed.

Anything where you're reviewing or auditing is IMO classic verification.

Validation - can it be effective
Verification - is it effective



#11 QATim

QATim

    Grade - Active

  • IFSQN Associate
  • 11 posts
  • 2 thanks
0
Neutral

  • United States
    United States

Posted 01 June 2012 - 06:26 PM

My experience is every auditor has had their own "quirks" around verification/validation just use common sense and stick to your schedule.



#12 esquef

esquef

    Grade - SIFSQN

  • IFSQN Senior
  • 374 posts
  • 232 thanks
40
Excellent

  • United States
    United States
  • Gender:Male

Posted 05 June 2012 - 07:41 PM

It seems that this a major issue for the world of food safety in general.


SQF's definitions from the Guidance docs (page 32) from the 6th Edition (November 2008):

Verification is proving that you're doing what you say that you're doing.
Validation is the proving that what you're doing is working and effective.



From SQF's Edition 7's Appendex 2: Glossary (February 2012):

Verification: Essentially verification as applied to control measurements seeks to prove that the control measure was done according to its design.
Validation: Essentially validation as applied to control limits seeks to prove that the intended result was achieved and that it actually worked.


Here's a cut and paste on the Codex Alimentarius' definitions:

GUIDELINES FOR THE VALIDATION OF FOOD SAFETY CONTROL MEASURES CAC/GL 69 - 2008

III. DEFINITIONS


Monitoring: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control.

Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.

Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.



Here's a link to an interesting artical in Food Safety Magazine from late 2009 which seems to come at the issue through ISO22000. A key "blurb" in the piece:

One way to think of the differences among validation, verification and monitoring is to use the following questions that are linked to basic grammar:

• Monitoring: Are the operations being done as intended? (present)
• Verification: Was the work done according to plan? (past)
• Validation: Will the plan work? (future)

LINK: http://www.foodsafet...d=3322&sub=sub1


So all in all it appears (to me at least) that this subject is about as clear as mud!



Thanked by 1 Member:

#13 GMO

GMO

    Grade - FIFSQN

  • IFSQN Fellow
  • 2,694 posts
  • 686 thanks
176
Excellent

  • United Kingdom
    United Kingdom

Posted 08 June 2012 - 07:36 AM

So all in all it appears (to me at least) that this subject is about as clear as mud!



This is because IME from this forum, SQF does not understand the terms as applied by Codex. Codex is 100% clear.

#14 esquef

esquef

    Grade - SIFSQN

  • IFSQN Senior
  • 374 posts
  • 232 thanks
40
Excellent

  • United States
    United States
  • Gender:Male

Posted 08 June 2012 - 03:05 PM

This is because IME from this forum, SQF does not understand the terms as applied by Codex. Codex is 100% clear.


I don't disagree, but if your company is SQF certified it probably to your advantage if you use SQF's definitions. :whistle:

#15 GMO

GMO

    Grade - FIFSQN

  • IFSQN Fellow
  • 2,694 posts
  • 686 thanks
176
Excellent

  • United Kingdom
    United Kingdom

Posted 12 June 2012 - 04:56 AM

I don't disagree, but if your company is SQF certified it probably to your advantage if you use SQF's definitions. :whistle:


Ha ha, yes, I wasn't saying that. Just expressing my frustration at SQF!

#16 retep

retep

    Grade - Active

  • IFSQN Associate
  • 22 posts
  • 1 thanks
0
Neutral

  • United States
    United States

Posted 12 June 2012 - 03:14 PM

Thank you all for your help in this explanation. We are in the process of becoming certified and it has become a regular conversation between my auditor and I in the area of verification and validation. It has proven difficult because we don't actually produce a product. We are a freight forwarder who handle other customers products and methods of verification and validation are difficult because he has said numerous times that my definitions are one in the same. These posts have helped some to show the difference between the two.



#17 bacon

bacon

    Grade - MIFSQN

  • IFSQN Member
  • 173 posts
  • 77 thanks
16
Good

  • United States
    United States
  • Gender:Male
  • Interests:NOAA HACCP & Better Process Control School Certified, GFSI Schemes (BRC/SQF) Certified, Woolworths Quality Assurance (WQA), USDC, FDA, U.S. Army and client audit preparation; Seafood Processing, Supplier Approval

Posted 17 September 2012 - 06:43 PM

For those frustrated with the whole Validation/Verification issue, please see my post below on another thread:

As Charles and John Antecki have mentioned (as well as many other people have commented on) the different uses of Verification vs. Validation per Codex, HACCP/FDA and SQF....

Please note on page 23 of SQF Code (issue 7)

"1.9 SQF Guidance Documents":

"The guidance documents are available to assist the supplier, but are not auditable documents. Where there is a
divergence between the guidance document and the SQF Code, the SQF Code prevails."


It appears that SQF noticed their inconsistency with their references on page 36:

b) References
The SQF Code makes reference to the current edition of the CODEX Alimentarius Commission Guidelines for the
Application of the Hazard Analysis and Critical Control Point (HACCP) System and the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF) Hazard Analysis and Critical Control Point Principles and Application
Guidelines, adopted August 14, 1997.


So, if one references ones definition source, one has a solid defense.




This may help.
Cheers
____________________________________________________
><((((º> Salmon of Doubt & NOAA HACCP lover of Bacon

Thanked by 1 Member:

#18 raymond.holliday

raymond.holliday

    Grade - Active

  • IFSQN Active
  • 2 posts
  • 0 thanks
0
Neutral

  • United States
    United States

Posted 20 September 2012 - 12:27 PM

This is always a constant discussion at our plant. I'm stuck in the middle between implementing food safety in the plant as a leader and one that has it roled out to. This is one that always gets confused.



#19 williamw

williamw

    Grade - AIFSQN

  • IFSQN Associate
  • 36 posts
  • 32 thanks
3
Neutral

  • United States
    United States

Posted 25 February 2013 - 10:18 PM

Additionally for food, the Americans tend to position validation as a subset of verification often unlike the Europeans (but not, predictably, the Irish I believe.)

I think the problem arises from that fact that validation was not included in the original statement of the seven principles of HACCP. When it became apparent that validation should be included the formulators kept the seven principles and morphed one into verification/validation. In hindsight it would probably have been better to have added another principle so that we would have 8 principles with validation standing on its own since validation and verification are two distinct activities.

#20 williamw

williamw

    Grade - AIFSQN

  • IFSQN Associate
  • 36 posts
  • 32 thanks
3
Neutral

  • United States
    United States

Posted 25 February 2013 - 10:46 PM

I don't really have a problem with keeping the formal definitions -- at least in my mind -- separated. Validation shows that when you apply a control according to the established procedures the control will accomplish the intended results. Verification simply assures that the control is being applied according the established procedure.

In some cases it is easy to keep these two separate in the real world, as with the micro "kill steps" (yes I know it is not truly a "kill" step but a log reduction). So validation is determining through scientific evidence that when you apply a set process (typically time and temperature but other parameters often apply) you will accomplish the intended log reduction in the targeted organisms. (Depending upon the system actually accomplishing the validation can be difficult, but that is another story.)

Verification is making sure that you apply all of the required processing parameters (time, temperature, etc) according to the established procedures that you have validated.

But what happens when we get to the metal detector? At this point things start to get muddy. We typically verify the metal detector by passing test pieces through it and assuring that it kicks them out as intended. But isn't this also the same thing as validation? After all what we want to show through evidence is that our metal detector effectively kicks out product with metal objects of a particularly size of larger, which is essentially what you would do for validation.

In our SQF system the "validation" of the metal detectors is the annual factory calibration service to assure that the metal detectors are performing according to established specifications. This satisfies our auditors, but in my mind this is not really "validation"



#21 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 17,360 posts
  • 4836 thanks
943
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 26 February 2013 - 04:25 AM

I don't really have a problem with keeping the formal definitions -- at least in my mind -- separated. Validation shows that when you apply a control according to the established procedures the control will accomplish the intended results. Verification simply assures that the control is being applied according the established procedure.

In some cases it is easy to keep these two separate in the real world, as with the micro "kill steps" (yes I know it is not truly a "kill" step but a log reduction). So validation is determining through scientific evidence that when you apply a set process (typically time and temperature but other parameters often apply) you will accomplish the intended log reduction in the targeted organisms. (Depending upon the system actually accomplishing the validation can be difficult, but that is another story.)

Verification is making sure that you apply all of the required processing parameters (time, temperature, etc) according to the established procedures that you have validated.

But what happens when we get to the metal detector? At this point things start to get muddy. We typically verify the metal detector by passing test pieces through it and assuring that it kicks them out as intended. But isn't this also the same thing as validation? After all what we want to show through evidence is that our metal detector effectively kicks out product with metal objects of a particularly size of larger, which is essentially what you would do for validation.

In our SQF system the "validation" of the metal detectors is the annual factory calibration service to assure that the metal detectors are performing according to established specifications. This satisfies our auditors, but in my mind this is not really "validation"


Dear williamw,

No argument that the interpretation / implementation of "validation" is a matter of opinion. Semantics is a very ubiquitous science / art. :smile:

One additional characteristic / distinction (to verification) regarding validation that Codex emphasises is the chronology (hypothetical or otherwise), eg see post # 3. SQF seems to have a more general viewpoint.

In other fields a whole host of self-defined "validations" co-exist.

I daresay yr factory procedure could be classified as revalidation (based on routine only :smile: ). Some might call it (pure) verification.

Codex also discusses metal detectors as validatory objects where a preceding removal device(s) exist.

Not to forget the longest running thread on this forum, i think.

SQF (from memory) states in its glossary that it welcomes both Codex and NACMCF viewpoints on haccp. But perhaps the surrounding text occasionally seems otherwise. :whistle:

Rgds / Charles.C

Kind Regards,

 

Charles.C


#22 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 17,360 posts
  • 4836 thanks
943
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 26 February 2013 - 09:53 AM

I think the problem arises from that fact that validation was not included in the original statement of the seven principles of HACCP. When it became apparent that validation should be included the formulators kept the seven principles and morphed one into verification/validation. In hindsight it would probably have been better to have added another principle so that we would have 8 principles with validation standing on its own since validation and verification are two distinct activities.


Dear williamw,

I am for sure no historian but after a quick look at IT, I deduced this much –

Both Codex and NACMCF originally included Validation within Verification in their famous 7-principle, haccp publications of 1997, the latter in considerably more detail, eg –

http://www.fda.gov/f...P/ucm114868.htm

Other European groups shortly recommended “elevation” of the status of the Validation feature, eg this 2001 document –

Attached File  validation and verification of HACCP, ILSI, 2001.pdf   104.58KB   121 downloads

Subsequently Codex further expanded their interpretation of Validation and its distinction from Verification in their 2008 publication.The USA seems to have meanwhile maintained the 1997 concept , eg compare first link to -
http://edis.ifas.ufl.edu/fs143
(this link does not appear to attach much importance to the chronology aspect)

Nonetheless, the basic interpretation and chronology aspects of validation in the 1997 NACMCF document still look very similar (to me) to the current Codex version (2008). This 2012 link summarises the terminology situation in US meat industry –
http://www.birkocorp...n-verification/

If anything, it looks to me like SQF has simply chosen to be “quirky”. :biggrin:

Rgds / Charles.C

Kind Regards,

 

Charles.C


Thanked by 1 Member:

#23 williamw

williamw

    Grade - AIFSQN

  • IFSQN Associate
  • 36 posts
  • 32 thanks
3
Neutral

  • United States
    United States

Posted 27 February 2013 - 04:33 PM

The 1997 NACMCF document is a revision of the 1992 HACCP guidelines and there was also something publish by NACMCF in 1989 that discussed the 7 principles. I have not been able to find the 1992 document online but if I remember correctly it did not include validation which is why I believe that when it was added it was basically force fitted into the verification principle to maintain 7 principles. I may have a paper copy of the 1992 document stored away in some of my old HACCP training materials I developed in the mid-90's so if I can find it I will scan it and make it available for those that might have an interest in the history and evolution of HACCP.



#24 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 17,360 posts
  • 4836 thanks
943
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 28 February 2013 - 01:25 AM

The 1997 NACMCF document is a revision of the 1992 HACCP guidelines and there was also something publish by NACMCF in 1989 that discussed the 7 principles. I have not been able to find the 1992 document online but if I remember correctly it did not include validation which is why I believe that when it was added it was basically force fitted into the verification principle to maintain 7 principles. I may have a paper copy of the 1992 document stored away in some of my old HACCP training materials I developed in the mid-90's so if I can find it I will scan it and make it available for those that might have an interest in the history and evolution of HACCP.


Dear williamw,

I had a look through my hardcopy archives. You are certainly correct in that the 7-principles originated pre-1997, possibly even pre-1989.
Regarding validation, i agree with you that it looks to have been somewhat of an afterthought.

I can see 3 particular haccp documents referenced prior to the 1997 on-line items but there may well have been others –
(a) the NACMCF publication adopted in November 1989
(b) a Draft Codex report on HACCP circulated in October 1991
© the NACMCF publication adopted in March 1992

None of (a-c) seem to be on the IT.

Comments
Each document contains the 7-principles.

With respect to validation, these documents are not very informative concerning specific requirements or chronology within the development of the haccp plan. I guess this reflects the changes in thinking which were occurring over haccp implementation at the time.

(a) NACMCF/89 has no mention of validation anywhere, including the definition list.
(b) CODEX/91 has a 1-line mention as a possible activity within verification, (Codex principle 6). No further details. There is no list of definitions.
© NACMCF/92 has a listed definition –“an initial review to ensure that all elements of the haccp plan are accurate”. No further details / mentions.

In fact, for Codex, the 1997, 2003 revs also contain very little additional information regarding requirements and chronology for validation other than a rather ambiguous, listed definition – “obtaining evidence that the elements of the haccp plan are effective”.

In contrast, the NACMCF 1997 rev, has a much clearer definition – “That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.”
This represents a quite precise chronological statement.
2 sections of the previous 4 constituting the 1992 Verification Principle have now been categorised as validation components but still maintained within the 1997 Verification Principle.

The Codex document on Validation Guidelines appeared in 2008 which implicitly separates the Va process from the Ve Principle –

Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.
Detailed examples are given.
This represents a quite precise chronological statement. Some obvious similarity to NACMCF 1997.

Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.
Also precise in the chronological sense.

So, regardless of which system mentioned above is selected, the chronology for Va now seems identical. And similarly close for Ve if one considers only the verification component(s) within the Verification Principle of NACMCF 1997.

I still feel that if SQF had accurately followed the (updated) haccp intentions of Codex and NACMCF in the Standard’s text, the oddities as variously discussed on this forum should not have occurred.

Rgds / Charles.C

Kind Regards,

 

Charles.C





0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users

EV SSL Certificate