SQF Manufacturing Edition 8.1 - 2.5.1.1
I feel like I am going in circles with the auditor on 2.5.1.1. Can anyone provide examples on what you use for this? I have provided reassessment verifications, GMP verifications. Everything that I know of, and it is not accepted.
This is from SQF Ed 8.1
2.5.1.1 The methods, responsibility and criteria for ensuring the effectiveness of all applicable elements of the SQF Program shall be documented and implemented. The methods applied shall ensure that:
i. Good Manufacturing Practices are confirmed to ensure they achieve the required result;
ii. Critical food safety limits are validated, and re-validated annually;
iii. Changes to the processes or procedures are assessed to ensure controls are still effective;
iv. All applicable elements of the SQF Program are implemented and effective.
Do you have measurements of any of these items? Daily checklists to see what is being observed? How did you come to your Critical Limits?
I'm also very curious as to why you are being Audited against SQF version 8.1
Yes, I have a daily document check off list. Which is when all SSOP, GMP and HACCP checks are reviewed and verified. We are audited on this, because i took a six month leave and the person who filled my position had no clue what they were doing, they hired a private consultant who ultimately changed everything and had things in place that we don't even do or have implemented. So on the audit that was done during that time went horribly wrong, had to have this surveillance done which is why it's on 8.1. This audit went so much better, only very few non conformities found. They are also hitting me on 2.5.5.3. I've given them preventative maintenance, weekly maintenance request, I am pretty lost on this as well.
if you have a CCP, did you provide everything re: your limits and deviation procedures when they are exceeded?
were you able to give them preventative maintenance logs? not just the procedure, but the documentation that those things were actually done?
Yes, i gave them complete preventative maintenance logs yet they say the information provided doesn't address auditing the site and equipment periodically.
And for 2.5.1 I've provided CCP deviations etc. I feel so lost.
Do you have anything that shows that the maintenance department does a regular facility walk through that is documented? I worked with a maintenance manager that had a goal of making sure he or his staff put their hands on every piece of equipment once a month to get used to how it should run/sound/act, plus a monthly perimeter check. This worked really well.
from the 8.1 guidance doc
2.5.5.3 Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing Practices and building/equipment maintenance is compliant to the SQF Food Safety Code for Manufacturing.
The site shall:
i. Take corrections or corrective and preventative action;
and
ii. Maintain records of inspections and any corrective action taken.
Sounds to me like your auditor is looking for "regular inspections" from the first line, but that is what the preventative maintenance schedule shows. Do you have a PM schedule? What is inspected and when/frequency?
I feel for your situation. We were very fortunate with the consultant we used years ago to help us with SQF. He spent time at our plant, learned our process and helped me understand the code better. He was a huge help. However one of our sister plants switched from BRC to SQF a few years ago and their consultant came in for a couple of days and then made recommendations that did not fit and did not catch that support for some of the items was not in place. Needless to say, they did not do well on the audit after the consultation, just like your situation. It was a shame. - It sounds like you have taken great strides in getting things back in alignment so hopefully next year will not be so dramatic for you. - I don't know if it will help you with your argument but below is what we do to meet the requirements and we have not had any non-compliances on our audits for these sections.
2.5.5.3 - We have monthly GMP Audits where we break our GMP's out into sections and complete an audit on one of the sections each month. We also have Facility Audits monthly where we audit the exterior and non-production areas one month, raw end one month and the RTE end once a month verifying the facility, equipment and pest control preventions are all in good condition and helps us address items that need some attention. If one of your PM's requires these types of checks then that is what you want to show the auditor but that will not help with the GMP's as I doubt there is a PM for Maintenance for them to verify GMP's are being followed. Do you have something in place for verifying GMP's?
2.5.1.1 - i. and iv. For the Validation section of the code we lined out how we would validate each section of the code. Most often we used lack of Customer Complaints or Deviations and for some Microbiological Sampling Results to show we did not have trends of issues for that section. Although some sections are specialized such as calibration that we reviewed the calibration records to show there was not a trend of equipment being out of calibration.
ii. HACCP Validation should be covered under your HACCP / Food Safety Plan. For the annual validation we do an annual review and state that no changes have been made to the plan that would affect the CCP limits or process so the original validations are still effective and the auditors we have had seem to be good with that. We also reassess our SSOP's annually.
iii. Anytime there is a change to the process or procedures you document them and determine if controls are still effective or if any changes are needed. For example we put in new metal detectors so we had to reassess our test standards to ensure they were still applicable for the new equipment and we were actually able to move to a smaller standard test size, which was great.
I feel for your situation. We were very fortunate with the consultant we used years ago to help us with SQF. He spent time at our plant, learned our process and helped me understand the code better. He was a huge help. However one of our sister plants switched from BRC to SQF a few years ago and their consultant came in for a couple of days and then made recommendations that did not fit and did not catch that support for some of the items was not in place. Needless to say, they did not do well on the audit after the consultation, just like your situation. It was a shame. - It sounds like you have taken great strides in getting things back in alignment so hopefully next year will not be so dramatic for you. - I don't know if it will help you with your argument but below is what we do to meet the requirements and we have not had any non-compliances on our audits for these sections.
2.5.5.3 - We have monthly GMP Audits where we break our GMP's out into sections and complete an audit on one of the sections each month. We also have Facility Audits monthly where we audit the exterior and non-production areas one month, raw end one month and the RTE end once a month verifying the facility, equipment and pest control preventions are all in good condition and helps us address items that need some attention. If one of your PM's requires these types of checks then that is what you want to show the auditor but that will not help with the GMP's as I doubt there is a PM for Maintenance for them to verify GMP's are being followed. Do you have something in place for verifying GMP's?
2.5.1.1 - i. and iv. For the Validation section of the code we lined out how we would validate each section of the code. Most often we used lack of Customer Complaints or Deviations and for some Microbiological Sampling Results to show we did not have trends of issues for that section. Although some sections are specialized such as calibration that we reviewed the calibration records to show there was not a trend of equipment being out of calibration.
ii. HACCP Validation should be covered under your HACCP / Food Safety Plan. For the annual validation we do an annual review and state that no changes have been made to the plan that would affect the CCP limits or process so the original validations are still effective and the auditors we have had seem to be good with that. We also reassess our SSOP's annually.
iii. Anytime there is a change to the process or procedures you document them and determine if controls are still effective or if any changes are needed. For example we put in new metal detectors so we had to reassess our test standards to ensure they were still applicable for the new equipment and we were actually able to move to a smaller standard test size, which was great.
Hi Mulan,
Thanks for the comments/suggestions.
Re ^^^(red) - It's a historically topsy-turvy SQF topic of course but I would argue this is (Codex) Verification, not Validation. Possibly an equal comment towards your auditors. :smile:
Hi Charles - As always I appreciate your attention to details. I would agree that what we do for the section highlighted is not truly a validation and would not meet the requirements for HACCP. I think Validation is a confusing topic in the first place and SQF's section on Validation makes it even more so. However, what we have been doing for sections i. & iv. was suggested by a SQF Trainer and supported by a SQF Consultant to meet the code. The method seems to work for the auditors we have had so I figured I would share.
I'm not sure what the auditor is looking for. What i have done is create a Matrix of verification and validation/ "ensuring effectiveness". There are are a few examples of these in older posts. I have both a verification and validation matrix for everything is section 11 and the other items that are listed. I feel that it is important to define how you will prove that you are doing what you said & prove that what you are doing is effective.
Sanitation for instance. You will review logs or charts to prove that sanitation was completed. You will conduct APT or micro testing to prove that sanitation was effective.
https://www.ifsqn.co...ng-methods-etc/
As scampi stated, 2.5.5.3 is intended to be a regular inspection of your facility as scampi stated. These are intended to be an inspection of the plant to find deficiencies in GMPs, issues with equipment and facility that pose a risk to food safety, cleanliness, pests, etc.