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MMQA

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Posted 11 January 2023 - 09:51 PM

Hi, I am hoping to get some feedback on something that I may be overthinking.

I currently took over a QA manager position that has been vacant for a while. I have observed the process and read the procedures and food safety plan and, lets just say it is not really a system and most does not make sense. I am thinking of doing the annual reassessment and updating the procedures to reflect what is actually being done, and adding some elements that are missing. Some of the changes I have in drafts are the procedures for non conforming product and equipment, corrective and preventive action, and document control (so far). My concern is that my changes may be too drastic for an annual reassessment, (some of these procedures are dated from 2017 and do not have any real meat to them). Should these types of changes be linked to an internal audit of the system or the verification/validation of the system?  I have gone back and forth on how to fix the procedures and how to go about documenting why they had to be fixed. Should I go through all the procedures as an annual reassessment, update them, do the training and implement them and afterwards worry about doing my internal audit? Any feedback is appreciated.



Charles.C

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Posted 12 January 2023 - 11:55 AM

Hi, I am hoping to get some feedback on something that I may be overthinking.

I currently took over a QA manager position that has been vacant for a while. I have observed the process and read the procedures and food safety plan and, lets just say it is not really a system and most does not make sense. I am thinking of doing the annual reassessment and updating the procedures to reflect what is actually being done, and adding some elements that are missing. Some of the changes I have in drafts are the procedures for non conforming product and equipment, corrective and preventive action, and document control (so far). My concern is that my changes may be too drastic for an annual reassessment, (some of these procedures are dated from 2017 and do not have any real meat to them). Should these types of changes be linked to an internal audit of the system or the verification/validation of the system?  I have gone back and forth on how to fix the procedures and how to go about documenting why they had to be fixed. Should I go through all the procedures as an annual reassessment, update them, do the training and implement them and afterwards worry about doing my internal audit? Any feedback is appreciated.

Did it pass the SQF Audit OK ?

 

Sleeping dogs ..... vs New Brooms ....?

 

I daresay it depends on the context ?


Kind Regards,

 

Charles.C


Scotty_SQF

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Posted 12 January 2023 - 12:10 PM

Since you are new to the role/taking over, I think it is perfectly understandable that you would review the system and make changes where you see fit.  When I have taken over/started a new role in company with established food safety programs, within my first month I review the entire program, document my review in some sort of reports and then proceed with any changes I feel could strengthen or help out the already established program.  I would just have it as your initial assessment of how the program stands with you now overseeing it.  Hope this helps.



Scampi

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Posted 12 January 2023 - 01:04 PM

I would do both concurrently instead of duplicating the work

 

Where I am, they had only ever done the required IA as per SQF and sooooooooo many PRP were non sensical and outdated (including regulatory references that no longer existed)

 

The new procedure moving forward is the entire PRP/FSP/IA review done throughout the year.  I include the SQF element number in the header of the written program so it's easier to find the SQF internal audit (which in my mind is a PRP reassessment anyway)


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Kara S.

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Posted 12 January 2023 - 02:20 PM

In the meantime, at least ensure your documents match what you are currently doing. Keep the old versions as reference. 

 

I think you should have a sit down with the other managers/ food safety team. Honestly, many places I have worked, some of managers don't fully understand that GMPs are in the US regulations. they think its just some QA Dept. rule. 

  1. Read the GMP regs together 
  2. Assign responsibilities to each department. 
  3. From there, mirror what you just went through to your SQF system. So somewhat go prepared with categories and who you think will should be more involved with each category. 
  4. Make an action plan on how you want to comply to GMPs/SQF code - begin making those PRPs to meet your food safety needs. 
  • Making ALL the changes at once might be overwhelming. Set a realistic goal for reviewing the plant programs and making changes. Your food safety system is a live document, so auditors will understand that you have reviews and ongoing changes. You should just highlight the areas you want to improve within the reassessment meeting and then execute in phases whether by line, department, position. 
  • Set timeline goals for when you would like something to be accomplished by. Example: QA Manager & Supply Chain Manager to review Receiving procedures & documentation. Compare what we are currently doing to what you both envision. Present to Food Safety Team at next meeting. 2 weeks for policy and form changes, training of employees by XX/XX/XXXX. Implementation, monitoring, & mentoring employees on change 2 weeks. 

 

Training will be integral for success and having the other managers on board will also help with executing that change. 


Kind regards, 

 

Kara

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MMQA

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Posted 12 January 2023 - 02:52 PM

I would do both concurrently instead of duplicating the work

 

Where I am, they had only ever done the required IA as per SQF and sooooooooo many PRP were non sensical and outdated (including regulatory references that no longer existed)

 

The new procedure moving forward is the entire PRP/FSP/IA review done throughout the year.  I include the SQF element number in the header of the written program so it's easier to find the SQF internal audit (which in my mind is a PRP reassessment anyway)

Thanks for your feedback. Yes, I though about doing it both at the same time. In the past (with my very controlled system) I did my annual reassessment and then had my internal audit during which I did the needed verification/validations. One of my (many) thoughts is what you mention, doing the internal audit now that will trigger these reassessments. I was thinking of doing verification/validations after I have had the systems in place for a few months.



MMQA

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Posted 12 January 2023 - 03:04 PM

In the meantime, at least ensure your documents match what you are currently doing. Keep the old versions as reference. 

 

I think you should have a sit down with the other managers/ food safety team. Honestly, many places I have worked, some of managers don't fully understand that GMPs are in the US regulations. they think its just some QA Dept. rule. 

  1. Read the GMP regs together 
  2. Assign responsibilities to each department. 
  3. From there, mirror what you just went through to your SQF system. So somewhat go prepared with categories and who you think will should be more involved with each category. 
  4. Make an action plan on how you want to comply to GMPs/SQF code - begin making those PRPs to meet your food safety needs. 
  • Making ALL the changes at once might be overwhelming. Set a realistic goal for reviewing the plant programs and making changes. Your food safety system is a live document, so auditors will understand that you have reviews and ongoing changes. You should just highlight the areas you want to improve within the reassessment meeting and then execute in phases whether by line, department, position. 
  • Set timeline goals for when you would like something to be accomplished by. Example: QA Manager & Supply Chain Manager to review Receiving procedures & documentation. Compare what we are currently doing to what you both envision. Present to Food Safety Team at next meeting. 2 weeks for policy and form changes, training of employees by XX/XX/XXXX. Implementation, monitoring, & mentoring employees on change 2 weeks. 

 

Training will be integral for success and having the other managers on board will also help with executing that change. 

Thank you for your feedback. Most of these updates are probably going to be so that the procedure reflects what is going on out there, however inefficient I may find them now since, like you say, it is impossible to completely change everything, I am focusing energy on the programs that are in complete chaos for significant changes. Having done this for so long it is hard to see things being done in ways that are not the best.



kingstudruler1

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Posted 12 January 2023 - 07:15 PM

My concern is that my changes may be too drastic for an annual reassessment, (some of these procedures are dated from 2017 and do not have any real meat to them).

 

if policies/procedures don't meet the standard or are not what is actually happening, changes are needed.   Unfortunately, I have seen many facilities receive an undeserved high score for years.   When they finally get an auditor that isn't handing out scores, they nearly fail (and I don't use "fail" lightly).    It's a legitimate problem.   

 

On the flip side, I think you need to make sure you are being objective.   "it is not really a system and most does not make sense" doesn't strike me that you feel  like your out of compliance.   Maybe they just need some "refining/improving".  Thats fine and should be addressed as well.  However, I would caution a new person from making a bunch of changes in this area without consulting others on how and why procedures where written the way they were and why they are not "actually being done"   ex - Which is correct - the procedure or the practice?   

 

I personally like the use the audit checklists as the internal audit.  It is also a good tool for you to use to make sure you have reviewed what is in place and know where the appropriate documents and records are located.    I would go through the checklist and find everything that is not in compliance and make sure that you have the corrective and preventative actions in place for those.   For the items that you want to "refine/improve", I would just make a comment in the check list that it meets the standard,but could use "x" improvement(s).   


eb2fee_785dceddab034fa1a30dd80c7e21f1d7~

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G M

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Posted 12 January 2023 - 11:09 PM

It sounds like the food safety and quality system is going to ultimately be re-written for the most part.  As much as a like the idea of doing it all at once, that's not very practical since the facility is currently operating and a re-write is going to take a lot of time.


Edited by G M, 12 January 2023 - 11:11 PM.


Charles.C

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Posted 13 January 2023 - 12:30 AM

Hi MMQA,

 

I anticipate that your dissatisfactions over various QA aspects probably also extends to the SQF Auditors (always same one?) who have been seemingly either oblivious or unconcerned as to the failings you have encountered.

 

I certainly have reservations about certain SQF/FS viewpoints (my experience is only BRC) and their Scoring System however I get the impression that the many members here who utilize SQF Auditors are mostly reasonably satisfied with their capabilities. Perhaps your Plant has been one of the unlucky ones.

 

May I ask what is the Product being processed and the last SQF Audit Score ? (Hopefully not 99 !).

 

How about your MD / QA Team ? Are they in agreement with your opinion as to the necessity for making "drastic" changes ?


Kind Regards,

 

Charles.C


MMQA

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Posted 13 January 2023 - 03:12 PM

It sounds like the food safety and quality system is going to ultimately be re-written for the most part.  As much as a like the idea of doing it all at once, that's not very practical since the facility is currently operating and a re-write is going to take a lot of time.

 

Yes it will, but this is a process that has taken me several years in the past and it would be the same for this site. I just wanted to clarify that I did not mean I would make all the changes at once. I am focusing on those 3 procedures that would have the most impact right now. I feel the most noticeable (drastic) change is how the procedures would be written themselves, even if I am only updating most of them to reflect current practices. 



MMQA

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Posted 13 January 2023 - 03:16 PM

Hi MMQA,

 

I anticipate that your dissatisfactions over various QA aspects probably also extends to the SQF Auditors (always same one?) who have been seemingly either oblivious or unconcerned as to the failings you have encountered.

 

I certainly have reservations about certain SQF/FS viewpoints (my experience is only BRC) and their Scoring System however I get the impression that the many members here who utilize SQF Auditors are mostly reasonably satisfied with their capabilities. Perhaps your Plant has been one of the unlucky ones.

 

May I ask what is the Product being processed and the last SQF Audit Score ? (Hopefully not 99 !).

 

How about your MD / QA Team ? Are they in agreement with your opinion as to the necessity for making "drastic" changes ?

 

Yes, the consensus is that everything needs to be redone (but in my opinion, I do not think they understand just how much this is going to take to get this system to where it needs to be so they may be in for a rude awakening at some point, especially in the accountability department) It is snacks and baked goods and they are in the lower 90s. 



Scampi

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Posted 13 January 2023 - 06:13 PM

DO NOT rely on the auditor to catch anything valuable or important

 

Last year, unannounced audit; audit spent 6 hours of each day on the production floor----that doesn't leave very much time for PRP review (which in my opinion regardless of auditor is ALWAYS lacking)

 

This facility has scored a 91 or higher since 2011 and had never reviewed the entire plan (even though CFIA FSEP required it)

 

 

I certainly have reservations about certain SQF/FS viewpoints (my experience is only BRC) and their Scoring System however I get the impression that the many members here who utilize SQF Auditors are mostly reasonably satisfied with their capabilities. Perhaps your Plant has been one of the unlucky ones.


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