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Verification & Validation - scheduling, methods, etc.

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#1 idealdreams

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Posted 24 January 2017 - 04:17 PM

I'm reviewing our written policies/procedures as a part of our gap assessment audit in preparation for our desk audit on 2/7 and the only area that I'm still struggling with after 2 years of working with SQF are sections 2.5.1, 2.5.2, and 2.5.3, which are all about verification and validation.

 

I'm fully aware of what verification/validation is and we do both tasks daily extensively, but how do I go about implementing a schedule without forgetting something? Does anyone have any guidance on how to work through these sections?



#2 SQFconsultant

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Posted 24 January 2017 - 04:56 PM

I've got to ask the question - why with your desk audit only 2 weeks away are you still working on this?  You should have a min. of 3 months of implementation prior to the desk audit.

 

My suggestion if you can't get around the date is to not worry about forgetting something and just put your schedule together, the worst thing that happens is that the Auditor a write up on it and you simple correct it... and there is NO grading/score on the desk audit anyway.


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International Toll-Free: 800-546-1452

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#3 Kellio

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Posted 25 January 2017 - 09:42 PM

Hello,

 

Break down the prerequisite programs and determine the frequencies of your verification and validation.

 

3 types of validation

 

Program or Process Initial validation - Implementation of a new program or process. Validate!

Program or Process Revalidation due to a creation or change of process caused by Nonconformance, Corrective Action and Preventive Action, System Internal Audit results....

Program or Process Validation to make sure all the food safety programs, food safety plan,  CCP,s, PC's (FDA), are producing with the desired results. 

 

Verification - are your  food safety programs, food safety plan,  CCP,s, PC's (FDA) working? How do you know? Create a document where you capture the program and process standards and check that they are happening. 

 

"Trust but verify!'  President Ronald Reagan's slogan

 

This is a tough cookie for some if you do not understand the principles for HACCP.  I had a hard time myself for awhile at the beginning.  Do not feel bad, our QA Manager and VP of QA still do not get it a long with some of the senior management and we get hit on this every other audit.

 

I got to go I am in the middle of our Audit as we speak and had to comment. I hope it helps.

 

Good day!



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#4 Ryan M.

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Posted 25 January 2017 - 09:44 PM

I've got to ask the question - why with your desk audit only 2 weeks away are you still working on this?  You should have a min. of 3 months of implementation prior to the desk audit.

 

My suggestion if you can't get around the date is to not worry about forgetting something and just put your schedule together, the worst thing that happens is that the Auditor a write up on it and you simple correct it... and there is NO grading/score on the desk audit anyway.

 

No, not required to have 3 months of implementation prior to the desk audit.  It is only a document review, no records review.  The facility audit should have some level of records to review and an entire SQF system review (management review) completed prior to the facility audit.  However, no stipulation for timeline is stated for this either.



#5 Ryan M.

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Posted 25 January 2017 - 09:45 PM

I'm reviewing our written policies/procedures as a part of our gap assessment audit in preparation for our desk audit on 2/7 and the only area that I'm still struggling with after 2 years of working with SQF are sections 2.5.1, 2.5.2, and 2.5.3, which are all about verification and validation.

 

I'm fully aware of what verification/validation is and we do both tasks daily extensively, but how do I go about implementing a schedule without forgetting something? Does anyone have any guidance on how to work through these sections?

 

Start with documenting each task.  Then document frequency of each task.  With that you document who verifies, how, and what records are used to verify.  That's pretty much it if your only gap is a verification schedule.  

 

Do the same for a validation schedule.  Although, typically you don't have this scheduled as it is either annual or when something changes with your programs.



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#6 Parkz58

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Posted 25 January 2017 - 09:46 PM

Here's one I found on here some time ago - makes a good starting point, anyway!Attached File  Prerequisite Validation Worksheet.xls   19KB   318 downloads



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#7 Charles.C

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Posted 25 January 2017 - 10:34 PM

Hi Parkz,

 

Thanks for the excellent excel which is, I think, a delightful example of SQF's fairly unique/quirky interpretation of Validation. Almost a Work of Art. :smile:

 

Might add one comment though, afaik SQF changed/removed its textual requirement to require Validation of Prerequisites a few years ago.


Kind Regards,

 

Charles.C


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#8 agasr

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Posted 25 January 2017 - 11:00 PM

Greetings Charles, 
SQF still has that requirement under 2.5.2 and 2.5.4, as a mandatory requirements, page 61 & 62. http://www.sqfi.com/...Ed-7.2-July.pdf

 

In fact the draft version "8" has that as well, which is open for public comment now. http://www.sqfi.com/...public-comment/

 

Please clarify if I have misunderstood your comments. Thanks!

 

 

Greetings idealdreams, 

 

To address the code, we also approached in similar way as mentioned by other members above (Kellio, Parkz58). Yes, the task is time consuming... it will help ultimately. Hope this helps! Good luck with your audit. 



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#9 MQA

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Posted 25 January 2017 - 11:07 PM

Dear idealdreams,

 

The programs I have developed are for SQF. 

 

For the FSQMS*:

To satisfy the verification schedule, as per HACCP Codex requires I have the Verification Schedule.   This makes all auditors very, very happy. 

 

For internal use - a “working document” you could say:

To ensure all activities are covered from the verification/validation points you queried, I also have a document called QA Calendar.  This calendar includes specific dates of all requirements of the FSQMS to ensure all actions (verification/validation) are conducted, as required. 

 

Once all parties of the QA Team agree with the frequency time frame of each item, I use the filter system* and will print a copy for production, quality control, etc.  I tend to date items around external audits, and where possible away from peak production or shut downs, such as Easter, Christmas, etc. 

 

Please see samples of the Verification Schedule and the QA Calendar.  Please bear in mind: these two documents are developed for two separate companies, so will not coincide, nor would they detail all the information you require to satisfy your own food program, but hopefully they shall provide you with the guidance you require. 

 

Key = FSQMS | Food Safety and Quality Management System

Note = both documents are developed using Microsoft Excel 

 

 

Attached Files



... helping you achieve food safety & quality assurance...

Melbourne Quality Assurance | Australia
www.melbourneqa.com | janette@melbourneqa.com
Facebook | Twitter


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#10 Mulan1010

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Posted 25 January 2017 - 11:30 PM

The example Parkz58 and MQA are great examples.  I am including another example from a training class I attended to just to give you another perspective.  Set your schedule up for what works for your process and try to keep it simple using what you already have in place, whenever possible. 

 

Most of the verifications were already being done when we started SQF so we just built the verification schedule around what we were currently doing.  Unfortunately we had not really been validating other than for HACCP so we did have to work on the validation schedule and develop forms when we started.

Attached Files



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#11 Parkz58

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Posted 26 January 2017 - 02:54 PM

Wow, Mulan - very nice!  Thanks for sharing them with us!



#12 Charles.C

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Posted 26 January 2017 - 04:30 PM

Greetings Charles, 
SQF still has that requirement under 2.5.2 and 2.5.4, as a mandatory requirements, page 61 & 62. http://www.sqfi.com/...Ed-7.2-July.pdf

 

In fact the draft version "8" has that as well, which is open for public comment now. http://www.sqfi.com/...public-comment/

 

Please clarify if I have misunderstood your comments. Thanks!

 

 

Greetings idealdreams, 

 

To address the code, we also approached in similar way as mentioned by other members above (Kellio, Parkz58). Yes, the task is time consuming... it will help ultimately. Hope this helps! Good luck with your audit. 

 

Hi agasr,

 

Actually there are many previous threads here regarding the scope and implementation of SQF validation. It has always been one of SQF's less than enduring curiosities/confusions. Including, seemingly, to their auditors also.

 

I suggest you carefully re-read 2.5.2  The current situation afaik was also "validated" by an announcement some time ago on the SQF website (assuming it's still there) which is (somewhere) quoted in one of the above-mentioned threads. The "change" occurred from memory when SQF2000 was re-launched.

 

I can't comment on new draft as I haven't read it. Sorry.


Kind Regards,

 

Charles.C


#13 Charles.C

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Posted 27 January 2017 - 03:30 AM

Hi Mulan,

 

The example Parkz58 and MQA are great examples.  I am including another example from a training class I attended to just to give you another perspective.  Set your schedule up for what works for your process and try to keep it simple using what you already have in place, whenever possible. 

 

Most of the verifications were already being done when we started SQF so we just built the verification schedule around what we were currently doing.  Unfortunately we had not really been validating other than for HACCP so we did have to work on the validation schedule and develop forms when we started.

 

Thank you for yr attachments. I am intrigued by above Post and particularly the reference to a, I assume, official SQF Training Class. Assuming this was “current” and based on comments in yr Post I deduce that SQF are still instructing users of the Code that the latter  requires Prerequisite Programs to be, specifically, "validated".

 

The SQF web-site has -

 

 

What happened to the pre-requisite programs (PRPs) that were in section 6 of the SQF 2000 Code? What PRPs need to be verified according to 2.4.2.4?

The pre-requisite programs that were addressed under section 6 of the SQF 2000 Code did not go away. They have been integrated with other food safety fundamentals to avoid duplication. All PRPs must be documented, implemented and verified as per 2.4.2.4. Keep in mind that all food safety fundamentals (i.e., PRPs), critical limits and other food safety controls need to be verified as per 2.5.1.2.

 

 

 

Why are PRPs not required to be validated? Instead, they are required to be verified as described in 2.5.2.4. Can you provide clarification as to whether PRP’s require formal validation?

 

The term “validation” specifically applies to control limits and requires scientific analysis to demonstrate that control limits are effective. Based on advice from our stakeholders, we reworded the requirement for pre-requisite programs to state that the PRPs be “confirmed to ensure they achieve the required result rather” than “validated.” The intent is to clarify the intent of the Code so that the effectiveness of the PRP is being met.

 

http://www.sqfi.com/...f/faq/sqf-code/

 

The above seems crystal clear to me but is apparently not compatible with the content/instructions being presented in  current SQF Training classes.

 

It is possible that  the web-site has simply not been up-dated to reflect more recently implemented SQF decisions/ revisions ? Can you resolve the seeming contradiction ?


Kind Regards,

 

Charles.C


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#14 SQFconsultant

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Posted 27 January 2017 - 02:50 PM

Ryan, based on my experience as both an SQF Auditor and Consultant over the past 10 years that 3 months is about the minimum amount of time for implementation that most auditors are looking within.

It is not "stated" as you mention but was made mention during a number of get togethers with SQFI and others.

Having been present (remotely or on site) for many SQF desk and certification audits we ensure that our clients have everything ready and in place prior to the desk audit and on the last three audits requests have been made for records.

The 3 month rule falls under the common sense heading.

Not started... but suggested highly, kind of like how SQF does not state anything about someone picking their nose... you know that's wrong even though it is not "stated."

With that said, we have found that if our clients have at least 3 months of implementation past our 1 month of system development that regardless of what an SQF Auditor asks for-the SQF Practitioner(s) will be ready and even though the is no grading on the phase 1 audit it is wonderful when a client can either ace it or only have 1 or 2 CARs like our pet food client just did.


Warm regards,

 

Glenn Oster

 

SQF Certification & Implementation Consultant

Serving clients in: USA, Centro America & Caribbean Islands

International Toll-Free: 800-546-1452

USA Skype Number: 772-646-4115

 

www.GlennOsterConsulting.com


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#15 Mulan1010

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Posted 27 January 2017 - 06:59 PM

Hello Charles C. - First I would like to say that I really appreciate your help with this as well as any topics on the Forum; you always bring great insight. 

 

The class I received the form in was the last year of version 2000 before Version 7 of the SQF Code, so no, it is was not current.  However, we still use the same format.  The auditors do look at the verification and validations schedule every year, review the information and we have not received any issues or non-compliances for it during any of our SQF Audits.  

 

Until you mentioned in this discussion that the validations for SQF are not required for pre-requisites I had not realized it.  I did go back through and re-read the 2.5 section of the SQF code trying to look at it from a different perspective and now think I understand what you are saying .  We do not "validate" the pre-requisite programs but we should, as the guidance document explains, confirm them to ensure they are achieving the required result.  So instead of calling them validations (which, are only required for CCP's and CQP's) we should call them something else, maybe confirmations. :)  -  Please correct me if I have misunderstood your intent.

 



#16 Charles.C

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Posted 28 January 2017 - 12:42 PM

Hi Mulan,

 

Yr understanding of my interpretation of the PRP requirements is correct. But I’m not a SQF user so my deductions are based solely on SQF announcements/Guidance/posted “data”. The first 2  sources have already proved occasionally unreliable for other topics hence my inferential caution. Just as a possible caution example for current topic, the SQF 7.2 Guidance has –

 

The procedure indicates the frequency and methods used to validate and verify all applicable aspects of the SQF System including pre-requisite programs, control measures, critical limits, all quality control measures, and other aspects contained in the food safety plan and food quality plan (refer 2.5.2);

 

Thanks yr comments over Va/Ve experiences. Sadly this topic has generated a substantial history of confusion over the last few years but with, afaik, no definitive conclusion. Curiously, there seems to be no similar volume of correspondence for BRC.

.

The debate over the meaning of Va/Ve as being interpreted by SQF  probably started heating up here which was prior to release of Ed.7 -

http://www.ifsqn.com...ans/#entry43020

(Feb 2011)

 

The quotations in my Post 13 of current thread were probably placed on SQF website ca July 2012 after launch of Ed.7, presumably to reinforce the “validation-related”  textual changes in wording within  Ed 7 as compared to SQF2000.

 

There seems to be at least 2  major differences in SQF’s interpretations of Va/Ve  as compared to Codex –

 

(1) SQF (acc.website) apparently applies Validation only to “control”  Limits, Codex  applies it, inter alia, to haccp Control Measures and Critical Limits

 

(2) SQF seems to avoid consideration of  chronological aspects as detailed in Codex (2008) for control measures, eg –

 

Validation is performed at the time a control measure or a food safety control system is designed, or when changes  indicate  the  need  for  re-validation  (see  section  VII).  Validation  of  control  measures  is,  whenever possible, performed before their full implementation.

There  is  often  confusion  among  the  concepts  of  validation,  monitoring  and  verification.   Validation  of control  measures  as  described  in  this  document  is  different  from  monitoring  and  verification,  which  both take place after the validated control measures have been implemented.  Monitoring and verification are the tools  used  to  check  whether  the  control  measures  are  being  adhered  to  and  to  demonstrate  that  they  are operating as intended.

 

 

No.2 seems to be a primary factor (either explicit or implicit) in many of the posted confusions.

 

Here are 3, more recent, threads on this topic (one started by  the current OP!!) illustrating poster confusions regarding responses to validation aspects of SQF Standard and  findings in SQF audits

http://www.ifsqn.com...eting-sqf-code/

(dec 2014)

 

http://www.ifsqn.com...cy-and-methods/

(july 2015)

 

http://www.ifsqn.com...pre-requisites/

(sept 2015)

 

SQF Practitioner certifications  (in 2015) seem to be accepting documents which clearly are not compatible with my earlier quotations, eg  –

http://www.ifsqn.com...ods/#entry91376

 

SQF have apparently long been aware of the validation confusion, eg  –

 

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.

http://www.ifsqn.com...sqf/#entry81758

(December 2014)

 

The red sentence (to me) looks a bit of a cop-out, eg  passing the buck to the auditors.

 

I am unaware if the above opinion still prevails, or even accurately reflects the general SQF viewpoint however  it does seem that “validation” of PRPs is still being routinely done, reported in “validation” Forms and auditorially approved without any terminological comments. Conclusion – indeterminate.


Kind Regards,

 

Charles.C


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#17 Ryan M.

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Posted 28 January 2017 - 05:15 PM

Glenn,

 

You are right, more history of records and proof of program implementation typically lead to lesser CAR's during an audit.  However, it is not REQUIRED in the code.  Nose picking is not stated in the code either, do you know why?  Because the SQF code allows for food companies to implement SQF based on their operations providing them the flexibility.   Companies simply need to prove they are doing what is stated in the code for safety or safety and quality.  While it doesn't look great, how does an office worker picking their nose affect the safety or quality?  For that matter, even a production worker picking their nose (such as in the bathroom) and washing their hands thereafter affect safety or quality?

 

I have implemented SQF Level 2 and Level 3 in various facilities with less than 3 months of records to show for it.  As I'm sure you know from your experience there are many companies that want to implement SQF ASAP due to either a customer requirement, or wanting to get new customer(s).  Many times there isn't the luxury of time to develop 3 months of records.  An SQF audit with less than a month of records to show for the SQF system implementation can still be a great learning experience and a valid audit as long as the records show the company is operating a food safety / quality system.  The auditor can see if the company is going the right way with things.

 

Two things that really bother me:

 

1.  When auditors go outside of the code and "interpret" findings as CAR's that do not line up with the code.  If they want to make "observations" that's fine.

 

2.  Those involved in any audit shouldn't focus so much on the number of CAR's, but the type and severity.  There is far too much focus on the number of CAR's in my view.

 

 

Ryan, based on my experience as both an SQF Auditor and Consultant over the past 10 years that 3 months is about the minimum amount of time for implementation that most auditors are looking within.

It is not "stated" as you mention but was made mention during a number of get togethers with SQFI and others.

Having been present (remotely or on site) for many SQF desk and certification audits we ensure that our clients have everything ready and in place prior to the desk audit and on the last three audits requests have been made for records.

The 3 month rule falls under the common sense heading.

Not started... but suggested highly, kind of like how SQF does not state anything about someone picking their nose... you know that's wrong even though it is not "stated."

With that said, we have found that if our clients have at least 3 months of implementation past our 1 month of system development that regardless of what an SQF Auditor asks for-the SQF Practitioner(s) will be ready and even though the is no grading on the phase 1 audit it is wonderful when a client can either ace it or only have 1 or 2 CARs like our pet food client just did.



#18 SQFconsultant

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Posted 28 January 2017 - 06:28 PM

Oh yeah, that can be great learning experience all right. Now that was funny!!!


Warm regards,

 

Glenn Oster

 

SQF Certification & Implementation Consultant

Serving clients in: USA, Centro America & Caribbean Islands

International Toll-Free: 800-546-1452

USA Skype Number: 772-646-4115

 

www.GlennOsterConsulting.com


#19 Charles.C

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Posted 29 January 2017 - 01:52 AM

Glenn,

 

You are right, more history of records and proof of program implementation typically lead to lesser CAR's during an audit.  However, it is not REQUIRED in the code.  Nose picking is not stated in the code either, do you know why?  Because the SQF code allows for food companies to implement SQF based on their operations providing them the flexibility.   Companies simply need to prove they are doing what is stated in the code for safety or safety and quality.  While it doesn't look great, how does an office worker picking their nose affect the safety or quality?  For that matter, even a production worker picking their nose (such as in the bathroom) and washing their hands thereafter affect safety or quality?

 

I have implemented SQF Level 2 and Level 3 in various facilities with less than 3 months of records to show for it.  As I'm sure you know from your experience there are many companies that want to implement SQF ASAP due to either a customer requirement, or wanting to get new customer(s).  Many times there isn't the luxury of time to develop 3 months of records.  An SQF audit with less than a month of records to show for the SQF system implementation can still be a great learning experience and a valid audit as long as the records show the company is operating a food safety / quality system.  The auditor can see if the company is going the right way with things.

 

Two things that really bother me:

 

1.  When auditors go outside of the code and "interpret" findings as CAR's that do not line up with the code.  If they want to make "observations" that's fine.

 

2.  Those involved in any audit shouldn't focus so much on the number of CAR's, but the type and severity.  There is far too much focus on the number of CAR's in my view.

 

Hi Ryan,

 

Yr red comment is rather debatable IMO. Do you consider that no minimum should exist at all ?. I think SQF may be placing an unreasonable pressure on their auditors in this respect.

 

Here is BRC7's opinion -
 

 

Manufacturing units that are newly built or ‘commissioned’ must ensure that systems and procedures in place are compliant before an initial BRC audit is undertaken. It is at the discretion of the company when they wish to invite a certification body to carry out an audit; however, it is unlikely that full compliance can be satisfactorily demonstrated at an audit undertaken less than 3 months from commencement of operation. This is likely to be the situation even where the site for certification uses quality systems developed by other certificated companies in the group.

 


Kind Regards,

 

Charles.C


#20 Ryan M.

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Posted 29 January 2017 - 02:42 AM

Oh yeah, that can be great learning experience all right. Now that was funny!!!


It wasn't meant to be funny. The point is that an audit can be a learning tool. What, do you think only consultants can teach people things? That would be funny...and I've been a consultant, rarely are they effective at much of anything except laying out some ground work.

I look at every audit and inspection asa. Learning tool. Everyone should, those being audited and inspection and those doing the auditing and inspecting. Even a horrible audit or inspection is a learning tool. It usually is a wake up for upper management that they have to apply some actual resources. I've been there before too; it's all good even when an auditor walks out. Life goes on, he company goes on.

I guess you and I see things very differently.

#21 Ryan M.

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Posted 29 January 2017 - 02:50 AM

Charles,

Currently SQf does not have a "required" minimum although Glenn states the common practice is 3 months minimum. This probably stemmed from other GFSI schemes like BRC.

I don't think there should be a prescribed minimum. Why? Because every facility is different. Anyone worth their salt knows immediately when conversing with key people and walking through the facility if they are really ready or not. That's one reason why I prefer SQF because it is not prescriptive, it leaves most things in the hands of the facilities to figure out how to address. The other benefit of SQF is having the unites desk audit which sets it apart from BRC. Depending on the desk audit performance one can readily gauge when a facility will be ready for the facility audit. The desk audit is a review of all documented programs, policies, procedures, systems, etc.

It makes more sense to me to do the initial auditing in this manner. Typically, companies don't schedule their facility audit until they have had the desk audit so if they need more time to prepare for a facility audit they schedule accordingly.

I've led facilities where the desk audit was two weeks before the facility audit. I've also let facilities where the desk audit was several months before the facility audit because we were not as prepared at that time.



#22 Charles.C

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Posted 29 January 2017 - 04:41 AM

Hi Ryan,

 

Anecdotal but hopefully verifiable (somewhere) -

 

To achieve SQF certification, the supplier must document and implement the relevant modules of the SQF Code, at the level required (refer to 1.7). This requires a two stage process:
 
Document the SQF System – prepare policies, procedures, work instructions and specifications that meet the relevant modules of the SQF Code. In other words “say what you do.”
 
Implement the SQF System – implement the prepared policies, procedures, work instructions and specifications, and keep records to demonstrate compliance to the relevant modules of the SQF Code. In other words, “do what you say”. SQFI recommends that a minimum of two months of records be available before a site audit is conducted.

 

 

Attached File  BSI Certification Guidebook Addendum SQF (2015).pdf   431.37KB   61 downloads

 

 

 

 


Kind Regards,

 

Charles.C


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#23 Charles.C

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Posted 29 January 2017 - 04:46 AM

addendum

 

In fact it's stated in clause 1.8 of Code.

 

Another related thread/experiences  here  -

 

http://www.ifsqn.com...tial-sqf-audit/


Kind Regards,

 

Charles.C






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