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What sections need verification and validation in SQF?

SQF Verification Validation Internal Auditing

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#1 AANNFF

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Posted 28 November 2014 - 06:27 PM

Hi Everyone,

 

We just had our audit for the year (96% :happydance: ) and the auditor gave us an OFP for verification, valiation, and internal auditing.  In Section 2.5 SQF System Verification of Module 2, it states that ALL systems must be verified, and validated.  In various sections of Module 2 and 11, some  say verified, some say verified and validated, some dont mention verifying and validating at all.  Which is it?  Do you verify and validate all sections per 2.5 or do you go with what is listed in each of the other sections?

 

Also, I have it that we verify and validate one section during the first two weeks of the month and internal audit the same the last two weeks of the month for each section.  I was told it would be better if the whole process took 3 months and that I should be verifying one section, validating a second section, and internal auditing a third. For example, we currently review Module 11.3 in March.  We would verify and validate from March 1-15 and internal audit March 16-30.  I was told to switch it to verify in March, validate in April, and internal audit in May.  Thoughts?

 

I know that we didn't lose marks but I found it EXTREMELY fustrating because I had spent months going over the rules and coming up with a system and was proud of what we had.

 

Thanks!

AANNFF


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#2 Scampi

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Posted 28 November 2014 - 06:52 PM

I don't have any wisdom for you, but CONGRATS on the 96% :sleazy:


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#3 Myusername

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Posted 28 November 2014 - 09:07 PM

I was told by my auditor when it came to sqf verification, validation and internal audit " do what works for you and then prove it to me, because nobody really gets this part of sqf"

I went to a training course and Qa managers for 15 years or more were asking how this works, they we were pretty much told the same thing during the course.

 

my way of thinking
did you verify: yes
did you validate: yes

did you internal audit: yes
did you get a NC: No
 

Congratulations, whatever you did worked


 


Edited by Myusername, 28 November 2014 - 09:10 PM.

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#4 Charles.C

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Posted 29 November 2014 - 06:38 PM

Dear AANNFF,

 

If you try a little searching for "validation" within  the sqf forum here, you will see that many posters' audit experiences on this topic have been, to put it mildly, chaotic in respect to auditor consistency over interpretation of the standard's requirements.

And a similar although perhaps slightly less vehement opinion regarding verification.

From memory (ie might be wrong) sqf subsequently posted a monograph on their website elaborating their validatory expectations, eg alignment with Codex. It appears the update may have not yet been universally noticed.

 

As for yr opening comment "all systems..validated" i recently noticed their faq states that Prerequisites are not required to be validated. Take your pick. :smile:  Or check with yr expert practitioner ?

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


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#5 Mr. Incognito

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Posted 01 December 2014 - 12:58 PM

I think he's talking more about internal auditing than single clause verification or validation.

 

I've learned a lot about internal auditing while being at my current position.  A surefire way to make sure your entire system is properly internally audited is to take the time to list out all sections of your code and create questions based on the standard.  Then have your internal audit team go out and investigate all of the clauses.  For example:

 

2.2.1 Document Control

2.2.1.1 The methods and responsibility for

maintaining document control and ensuring staff

have access to current documents shall be

documented and implemented.

2.2.1.2 A register of current SQF System

documents and amendments to documents shall be

maintained.

2.2.1.3 Documents shall be safely stored and

readily accessible.

 

So you could have an internal audit guidance where you have this:

2.2.1 Document control

2.2.1.1

     1) Are the methods and responsibility for maintaining documents control documented and implemented?

     2) Is there a system to ensure that staff has access to current and relevant documents?  Is that documented and implemented?

2.2.1.2

     1) Is there a register of current SQF system documents?

     2) Does the register include any document amendments?

2.2.1.3

     1) Are documents safety stored?

     2) Are there any threats to stored documents such as water damage, pest infestation, etc?

     3) Are documents readily accessible?

     4) In the event of an emergency how long would it take to gather relevant documents?

 

 

Something like that.  It doesn't have to be exactly those questions per say but there should be questions that lead the auditors to check over every part of every clause.  Then those internal audits should be reviewed by management or the food safety team... or HACCP team... or whatever team you have that is in charge of food safety.  Then after their review they should either agree that there is a risk or no risk.  If there is risk they should create a corrective action.

 

Let's say for example on my 2.2.1.3 Q4 they find that it will take 4 hours to get to the documents.  That is excessive.  A corrective action may be to assign a better storage system by ordering more filing cabinets and placing them in a certain location.

 

It is important to have your auditors use their own brain however and not just follow your questions.  Teach them how an auditor digs into things and tell them that the more they uncover in this way the less the auditor will find during their audit.

 

I am under FSSC and I have 5 auditors to perform 114 audits of this type in a year.


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#6 Charles.C

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Posted 01 December 2014 - 02:36 PM

Dear Mr Inc,

 

Frankly I found the manouevres discussed in the post difficult to comprehend. Including those of the external auditor.

 

I thought one of the objectives of an sqf internal audit was, inter alia, to verify someone else's existing validation, eg

http://www.22000-too...audit-tips.html

 

Not another SQF peccadillo I hope. :smile:

 

Rgds / Charles.C

 

PS I feel obliged to stand by my criticisms of sqf's Va-Ve, even if not relevant in this instance :smile:


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Kind Regards,

 

Charles.C


#7 Mr. Incognito

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Posted 01 December 2014 - 03:43 PM

I'm not 100% versed in all of SQF I only spent a year and a half in it but with the experience I had with it, including the practitioner class, and my experience with FSSC based on what you said I believe a robust internal auditing program would remedy what he hit you on.  Obviously I only have the little bit you've been able to share and I don't know anything the auditor said or any subtext. 

 

There are some people here who have more years of SQF experience on here than I do and as Charles said there are many threads on Verification and Validation on IFSQN with many people who get confused over the two terms and how to appropriately apply them.  I'd be happy to see how other SQF people see the answer to this question.

 

 

Dear Mr Inc,

 

Frankly I found the manouevres discussed in the post difficult to comprehend. Including those of the external auditor.

 

I thought one of the objectives of an sqf internal audit was, inter alia, to verify someone else's existing validation, eg

http://www.22000-too...audit-tips.html

 

Not another SQF peccadillo I hope. :smile:

 

Rgds / Charles.C

 

PS I feel obliged to stand by my criticisms of sqf's Va-Ve, even if not relevant in this instance :smile:

 

I believe Internal auditing should be done to verify and validate that your entire FSMS meets the standard you are following by inspecting each area of the code VS your FSMS to ensure that you are meeting each area of the code that you are expected to follow.  An easy way to do this (easy being relative to landing a spacecraft safely on the Sun) is to look at each part of the code and ensuring that you satisfy it within your FSMS.  Verifying that your documentation and practices meet the standard and checking your validation on what you are doing, why you chose to do it, and if the science behind your CCP's and CP's (or oPRPs) are still valid which is something that the HACCP team typically should look at during their annual review as well. 

 

Charles I'm not sure where you saw something about an external auditor in my first post other than mentioning to your auditors the more they uncover during internal audits will decrease how much the standard auditor will find during their inspection. 

 

That link you posted, for the most part, is what we do.  You start out looking at one thing and it could take you elsewhere when you see how the process is being performed.  Ours may not be exactly "system" so much is code lines but we were hit on our internal audits on our first audit for only having 4 questions asked on our internal audit on "GMPs" and only 2 of those questions being related to what the code required for GMPs so we created a new system for our audits doing what I outlined earlier. 

 

Basically right now what we are doing is looking at every section of code and auditing if we conform to the code.  So if the code says "Employees must wash their hands when entering production areas" we will watch the employees enter production and see if they wash their hands.  We'll also ask them on the floor "When are you required to wash your hands" and write down what they say.  We audit now more like the auditors for FSSC do by observing actions, documentation, and questioning the employees.


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#8 fgjuadi

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Posted 01 December 2014 - 04:32 PM

Verify -

4.1.5.1 FO COMPLAINTS 4.1.5.1.1 FO CUSTOMER COMPLAINT REGISTER 4.2.1.2 FO REGISTER SQF DOCUMENTS 4.2.1.2.0  FO REGISTER OF SQF FORMS 4.3.2.2 FO RAW MATERIAL SPEC REGISTER 4.3.3.1 FO PACKAGING MATERIAL REGISTER 4.3.6 FO FINISHED PRODUCT REGISTER 4.4.6 FO CORRECTIVE AND PREVENTATIVE SP 4.4.6 FO CORRECTIVE AND PREVENTATIVE 4.4.6.1 FO CORRECTIVE ACTION LOG 4.4.7 FO PRODUCTO NO CONFORME 4.5.1. FO MONITORING REGISTRY 4.5.1. FO VERIFICTION REGISTRY 4.5.4.1 FO POPCORN MVWT VOLUME LOG 4.5.4.2 FO POPCORN MACHINE SETTINGS LOG 4.6.1 FO TRAZABILIDAD LINEA DE MANZANAS 4.7.1 FO FOOD SECURITY INPECTION 4.7.2  FO FIRE EXTINGUISHER EMERGENCY LIGHT & EXIT LOG 5.2.5 FO ANNUAL LIGHT INTENSITY 5.10 FO GROUNDS INSPECTION 6.1.4 FO VISITOR GMP POLICY 6.1.4 FO VISITOR SIGN IN SHEET 6.3.7. TRAINING SIGN IN SHEET 6.3.0 TRAINING MATRIX  6.4 FO Equipment Calibraton Log 6.5.2.1 FO APPROVED PESTICIDE LIST 6.5.2.2  FO PEST SIGHTING LOG 6.5.2.4 FO INTERIOR TRAP MONITORING 6.6.1 FO MAINTENANCE CLEAN UP FORM 6.6.1 FO MAINTENANCE CLEAN UP GMP_SPNSH 6.6.1 FO REPARACION, DESPEJE, LIMPIEZA Y DESINFECCION DE MANTENIMIENTO DE EQUIPO  6.7.1 CHEMICAL MIXING FORMULA SP 6.7.1 FO REGISTER CLEANING & SANITATION APPLE LINE 6.7.1 FO REGISTRO LIMPIEZA Y DESINFECCION DE MANZANAS 6.7.1 FO TABLA DE QUIMICOS DE LIMPIEZA Y DESINFECCION 6.7.1.1 FO VERI. PREOPERACIONAL LIMPIEZA Y CONTAMINANTES 6.7.1. FO LIMPIEZA Y DESINFECCION DE SANITARIOS, LOCKERS Y CAFETERIA 6.7.1. FO VERIFICACION PREOPERACIONAL 6.7.3.2. FO CHEMICAL APPROVAL  6.7.3.3 FO PERSONAL PROTECTION HMIS 6.9.1.3 FO GLASS REGISTRY. 6.10 FO CONTRACT SERVICES VENDOR LOG 6.10 FO PACKAGING MATERIAL VENDOR LOG 6.10 FO RAW MATERIAL VENDOR LOG 6.10.0 SUPPLIER PERFORMANCE 6.11.1 FO TRUCK INSPECTION IN OUT BOUND FORM 6.11.1.1 FO VEHICLE INSPECTION LOG 6.11.2 FO RECEIVING GREEN APPLE LOT AND QUALITY REPORT 6.12  FO Waste Disposal Log

 

Validate -

                 
  6.1. Personnel Practices Internal Audit, Questionaire Interviewing, Visual Inspection,  6.2 Personnel Processing Practices Internal Audit, Questionaire Interviewing, Visual Inspection,  6.3 Training of Personnel Interviewing, Ck. GMP Violations log. / Internal Audits 6.4 Calibration of Equipment Validate Recognized Standards of the procedures used including those of recommended by the manufacturer. Thermometers, Metal Detectors, etc. Internal Audit Results 6.5 Management of Pest & Vermin Statistics on major issues with Pest and Vermin / Verification of PCO Monitoring Activities / Annual Pest Activity Summary Report / Internal Audits 6.6 Premises and Equipment Maintenance Internal Audits / Evaluate Data on Major or Critical Break Downs through CAR / Interviewing Maintenance Technicians on GMPs 6.7 Cleaning and Sanitation Swab frequency increase two fold to validate program / Internal Audits 6.8 Monitoring Water Microbiology Ck Yearly results / Lab. results and City. 6.9 Control of Physical Contaminants Part of HACCP Plan / Customer Complaint Log 6.10 Supplier Approval Internal Audit / Verification 6.11 Transport and Delivery Internal Audit / Verification / Interviewing  6.12 Waste Management and Disposal Internal Audit Building & Premises / GMP Audit 6.13 Allergen Control Allergen Rapid Testing statistical results review / Internal Audit results / Questionaire Interviewing 
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#9 AANNFF

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Posted 01 December 2014 - 05:37 PM

Thanks, everyone, for your input.  You'd think if so many people have problems with this part of the system, the SQF team would put something out to make it more clear for everyone.  :uhm:


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#10 RG3

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Posted 01 December 2014 - 05:43 PM

Hello AA NNFF,

 

First congratulations on the 96%.

 

"verify in March, validate in April, and internal audit in May.  Thoughts?"

 

It amazes me that people don't ask what the auditor is asking for inter alia or contest what the auditor is trying to give you a non conformance for. 

 

My thoughts: The reason the auditor had said this was because you need to verify all the policies address what the scheme is asking for and that the correct forms and versions are being used first. This can easily be done accompanying your internal audit/Management Review with your master document list. Next you need to validate what they are using is actually working. This is done by taking a series a records and translating the information into a nice chart or graph. From these two activities Va-Ve you make the necessary changes. This is why the internal audit is left for last. The internal should be treated as if you were ready to take on the audit "Audit Ready".

 

The way I understand the Va-Ve is like buying a car. You have something in mind before buying the car [the scheme] with the small details like a want a small car, blue, 17" tires, gets at least 32MPG, comfortable white interior, good stereo with an AUX input [all the clauses of the scheme]

 

You go the dealership [You go to the plant]

 

You look at the car you want. You verify is it small, is it blue, does it have 17" tires, does it have white interior, does it have a stereo with an AUX input, does it say it can get 32MPG? [verify if you have systems/policies/documents in place that say you conform with the scheme]

 

You get in the car you want. You validate by getting in the car and test driving the car. Is the white interior comfortable? Is it a good stereo? Is your electronic device compatible with the AUX input? Does it get 32MPG? [validate what you say in your policies is actually happening on the processing floor with records/questioning associates/trends/actions]


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#11 AANNFF

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Posted 01 December 2014 - 07:24 PM

Hi RG3,

 

I did ask and he just said that it would be better if it was done that his way (3 months vs 1 month).  I did manage to defend what I did and he just gave me an OFP rather than a minor.  I think it came down to the fact that he could see that I had everything but he didn't like the way that I organized it or did it.  I wanted to get the opinion of this forum to see which everyone thought was better.


Edited by AA NNFF, 01 December 2014 - 07:26 PM.

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#12 Setanta

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Posted 01 December 2014 - 07:31 PM

IMEX with SQF auditors (and one of the things that make me crazy) is that they will tell you have a deficiency but in order to avoid CONSULTING, they won't tell you much on how to fix it. 

 

Of course, I was just told at my audit 11/4-5 that SQF or our auditing body wasn't doing OFP anymore because if it was worth noting, it was worth a minor.  :bop:


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#13 TGM2010

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Posted 01 December 2014 - 07:46 PM

In my case, the Auditor said verification is different from internal auditing that is why they are separate elements of the SQF.


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#14 fgjuadi

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Posted 01 December 2014 - 08:01 PM

Ah, true, I use internal audits for some Validation, but never verification - here's the docs I posted earlier in a nicer / easier to read format, as they appear in the wilds of the production floor 

 

 


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#15 Charles.C

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Posted 01 December 2014 - 10:41 PM

Dear All,

 

Apologies in advance if I am incorrect but I believe the SQF standard (or the website) specifies that it’s reference for Va-Ve is Codex. And specifically Codex 2008.

 

If so, it seems to me that SQF has succeeded admirably in (a) bemusing its auditors as to the, IMO, crystal clear intentions of its own referenced source regarding  these important functions, (b) training its auditors to pass this bemusement on to their auditees.

 

One language difficulty which also recurs in published texts is that the words verify and validate have numerous, accepted, dictionary meanings when used in casual conversation. But, IMO, it is important to remember that in the context of the SQF standard they have, or should have, specific meanings as per the SQF code.

 

@ Mr Inc -

Charles I'm not sure where you saw something about an external auditor in my first post

 

Actually i was totally referring to the OP, sorry for lack of clarity

 

@ AANNFF, Not sure what OFP means and I’m unclear how you implemented yr own Va-Ve but IMEX (not SQF), once an item like a cooking process is validated prior to its routine usage, it simply stays validated as long as the results of the subsequent ongoing haccp verification activities support the bases/consequences of the validation. I don’t understand why you are having to do repeated validations every month. I would typically review validations annually if no specific reasons, eg significant process changes, product problems, etc require to do otherwise.

But perhaps I have missed some specific SQF directive regarding these terms.?

 

And, as per other posters comments, congratulations on 96%. As per RGE, definitely not a requirement as such, but  this surely entitles you to challenge the auditor as to the bases for their, IYO, unagreed suggestions (assuming you were correct of course and the auditor was a rational being). On the other hand, some people might prefer to internally self-note that, ITO, the auditor was talking nonsense but which could also be safely ignored. :smile:

 

Rgds / Charles.C

 

PS (added) - I checked "validation" in the sqf,ver.7.2 Glossary. The SQF's interpretation of Codex is still as unchangeingly bizarre as ever. Perhaps that partly explains the subsequent inadequacies.


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Kind Regards,

 

Charles.C


#16 Cathy

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Posted 04 December 2014 - 02:42 PM

SQFI recognized the difficulty with this topic which is why there was a one-day session on verification, validation and risk assessments prior to the last SQF Conference. The vast majority of all food sectors codes had something from section 2.5 as one of the top 10 non-conformance issues over the past year. The words can be confusing.  The essential thing is that each company can demonstrate how it affirms it is performing as promised and the system is effective. 


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#17 Charles.C

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Posted 04 December 2014 - 03:24 PM

SQFI recognized the difficulty with this topic which is why there was a one-day session on verification, validation and risk assessments prior to the last SQF Conference. The vast majority of all food sectors codes had something from section 2.5 as one of the top 10 non-conformance issues over the past year. The words can be confusing.  The essential thing is that each company can demonstrate how it affirms it is performing as promised and the system is effective. 

 

Dear Cathy,

 

Nice to hear from you and thanks for the input.

 

Although the Va-Ve terminologies are unquestionably subjective depending on your source,  IMO the Codex 2008 validation document is genuinely quite easy to understand and internally consistent (FSIS from memory also recently presented an excellent explanation).

 

The SQF-related confusion seemingly experienced by both auditees and auditors simply derives IMO from the SQF text within the SQF Code, Glossary and Guidance manual.

 

I assume it's a major issue to modify text which has carried over more or less unchanged for many years but at least the change regarding no validation for Prerequisites is, or should be, welcome,  assuming the faq I quoted in a parallel thread is in fact still valid. (One never really knows with SQF. :smile:)

 

Rgds / Charles.C


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#18 Wineohhcerts

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Posted 04 December 2014 - 08:43 PM

As I understand it from the SQF conference:

Verifications are done regularly as a review to ensure you are doing what your programs say you are doing. (A daily management review of HACCP records)

Validations are done at the end of the year to determine if your program is effective. (trending deficiencies or other measurable items)

Internal Audits should verify ALL aspects of the SQF system to ensure its effective/ (Mr. Inc has a simple example, although you will need hard facts in most cases and more than just a 'yes' or 'no')

 

Congrats on the 96%!


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#19 Mulan1010

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Posted 04 December 2014 - 10:10 PM

Congratulations on your 96%, that is wonderful. 

 

Internal Auditing - We have been through 7 SQF Audits, the last 5 at level 3, and after the 3rd one we discovered that SQF offers a "Checklist".  We purchased the Checklist and use it to base our internal audits off of.  Since doing so we have not had any issues with the internal audit section of the audit and we have had 4 different auditors.  The link for edition 7.2 is http://www.sqfi.com/...klist-final.xls.   We have a list/schedule of all of the SQF Sections (we broke it out into 44) and the month that we will be covering each section so that we eventually do them all over a year's time.  For Example: In January we perform Internal Audits on SQF Sections 2.1.1 Management Policy, 2.4.3 Food Safety Plan, 2.9 Training and 11.6.1-5 Storage.  In February we do 4 more sections and so on. 

 

Verification and Validations are very open as to what can be done as long as you can justify them.  Utilize what you do and have in place as much as possible so you are not adding extra work for yourself or others.  We have a log of all the Verifications and Validations that we do, who is to perform them and the time frame they are to be done in.  Some of the tasks frequencies are daily, some monthly, some quarterly, some 6 months and some yearly.  Some examples of what we do are: 

   Verify Thermometers - The operator compares the thermometer to a NIST Calibrated Thermometer in an ice bath or a hot bath daily depending on what they are monitoring at the start of the shift and the end of the shift. 

   Validate Thermometers - The supervisor observes an employee verify a thermometer for hot and for cold at least quarterly to ensure proper procedures are being followed and the NIST Reference Thermometers are sent in at least yearly for calibration.

   Verify Training - The supervisor is to either visually observe the employee and/or give the employee a written or verbal test and this is done within a two week time frame after any training is given. I will put in a plug for the Alchemy Training system.  We purchased it about 4 years ago and it has made the world of training much simpler for us.  Alchemy automatically tests the employees during the training so the verification and tracking of training is much easier than when we tried to do it ourselves.  Another plus is that the SQF Auditors we have had were familiar with the system and so this portion of the audit is a breeze now.

   Validate Training - At least yearly I review the Training Register to ensure that all topics have been covered for the year and that all employees have received the required training.


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#20 Charles.C

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Posted 05 December 2014 - 05:07 PM

As I understand it from the SQF conference:

Verifications are done regularly as a review to ensure you are doing what your programs say you are doing. (A daily management review of HACCP records)

Validations are done at the end of the year to determine if your program is effective. (trending deficiencies or other measurable items)

Internal Audits should verify ALL aspects of the SQF system to ensure its effective/ (Mr. Inc has a simple example, although you will need hard facts in most cases and more than just a 'yes' or 'no')

 

Congrats on the 96%!

 

Dear wineohhcerts,

 

Thks yr input and welcome to the Forum. :welcome:

 

I certainly hope that you have not correctly understood the conferences's consensus correctly although it would not surprise me unduly if you did.

 

If so, it would suggest that the reference word "Codex" can safely be deleted from the SQF Code as far as "validation" is concerned. :smile:

 

@Lee Ann, Appreciate yr detailed post but can you really reconcile the validation procedure which you describe with Codex 2008 ?, i couldn't. But at the same time i can equally understand that SQF will be perfectly satisfied.

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#21 CMHeywood

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Posted 08 December 2014 - 09:00 PM

The interpretation we use:

Monitoring = doing the checks and tests

Verifying = someone else confirms the checks and tests are being done.

Validating = management review any trends to confirm the controls are actually working.

 

For example, hairnets:

Audits verify if people are complying by wearing hairnets and wearing them properly.

Management review of the audits validates if you are maintaining this part of your personal hygiene program.

 

My opinion is that verifying and validating should occur on a frequency that is suitable for detecting noncompliance and reacting to any trends in a timely fashion.


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#22 Charles.C

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Posted 09 December 2014 - 11:14 PM

The interpretation we use:

Monitoring = doing the checks and tests

Verifying = someone else confirms the checks and tests are being done.

Validating = management review any trends to confirm the controls are actually working.

 

For example, hairnets:

Audits verify if people are complying by wearing hairnets and wearing them properly.

Management review of the audits validates if you are maintaining this part of your personal hygiene program.

 

My opinion is that verifying and validating should occur on a frequency that is suitable for detecting noncompliance and reacting to any trends in a timely fashion.

Dear CMHeywood,

 

I agree that in theory the choice of interpretation of Va/Ve is entirely up to you.

 

Unlike SQF, i presume you do not claim to be following Codex.

 

Rgds / Charles.C


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Kind Regards,

 

Charles.C


#23 RMAV

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Posted 11 December 2014 - 09:34 PM

I try to keep it simple and not lose the forest for the trees: what is the intent and main drive of the standard? Fulfill that purpose and justify it accordingly.

 

Congrats on 96!  A lot of people would like to have that score all the time


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