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HACCP Plan needs major overhaul, but audit is due!

Started by , Jul 31 2019 10:43 PM
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So I'm having a small dilemma and I was hoping everyone here could give me some insight/input.

 

I am new to this facility, and they have had several past QA Managers who have had years of experience in the food industry but zero experience in building Food Safety Programs.  The two previous in particular loved graphs and spreadsheets, and created so many and all these programs: and never followed through with more than one month of a single one...I'm guessing it was their goal to sit at their desk as much as possible to avoid any work whatsoever. 

 

I, while young, have had to build several HACCP plans and even designed my own Food Safety Program in a past work experience, so I know what needs done essentially.

 

I can have an unannounced audit starting very soon and while I've been here for only a short time, I've saved the HACCP plan review until now, so that I could learn and understand all the other programs that go into forming the HACCP Plan.  

 

What I'm seeing is that they have created a whole HACCP plan and because we have about 500 different raw ingredients, they have done their Raw Material Hazard Analysis based on very large groups of ingredients, vs individual: "all flavors" in house have one collective Raw Material Hazard Analysis.   Now I can see all powders, liquids, etc but not all 50 into one, they all have different bases etc.  I know that for the Food Safety Programs for FSMA this is more acceptable, but for HACCP and GFSI I have always learned to go by RM and not whole groups. 

 

I have a short period of time to review and have this HACCP Plan updated.  Do I go with this (that has passed on previous audits, although I don't know how) or start tackling and breaking it down properly into individual RMs, or smaller categories of groups and hope its completed by whenever they walk in? 

 

I guess I'm asking: What Would You Do?

 

Please help!!!

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Label it as a non-conformance upon review with a target completion date of like, two days after your unannounced audit window?   :ejut:

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Which standard are you being audited against? Depending on that answer, it may give you some wiggle room.
I have always done a hazard analysis/risk assessment for each individual RM, even if they are in the same "group" of materials.
 

Marshall

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Sounds like they're lucky to have you and you plan on tackling it either way. I like Marshenko's idea.

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I also like Marshenko's idea.

 

Do you know if you are getting the same Auditor that has done the previous audits, if so and the plan was accepted the last around -- well, you know where I am going with this and then right after the audit get to work on your plan for your plan.

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Hi Ashley,

 

Not a SQF (or flavour) haccp user so I can only give a generic opinion. (All FS Standards IMO can occasionally be unpredictably "finicky" in various characteristics).

 

The bases of  "grouping" methods for hazard analysis encompass a large variety of sometimes variable "items", including both (a) "related"  raw materials or (b) "related" processes. The interpretation of "related" is  malleable. Nonetheless, I think (but not familiar FSMA) that most validated haccp methods minimally include processes with closely similar CCP patterns.

 

For example, based solely on specific CCPs, very large but offhand dissimilar-looking processes have long been the (FDA/USDA-approved) standard grouping approach in foodservice applications such as School Kitchens.

 

As a corollary to Post5, is there a typical, validated grouping methodology in use in Flavour Industry? If so, this procedure may be initially familiar and thereby more readily acceptable to auditors. Other approaches may well be equally OK but may need more detailed justification/validation/references in preparation for an auditor.

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Which standard are you being audited against? Depending on that answer, it may give you some wiggle room.
I have always done a hazard analysis/risk assessment for each individual RM, even if they are in the same "group" of materials.
 

Marshall

 

SQF Food Safety (Level 2).  The last auditor spent so much time concerned on allergen cross contamination on the floor, that I'm guessing his look at the HACCP plan was a quick one, and maybe focused on Process HA (my last one at a previous place focused on Process vs RM HA).

 

It's a new auditor this time around.  The last one was banned from the facility after the last audit.  

Not a SQF guy, so I am not familiar with what the code specifically requires when it comes to RM hazard analysis.

 

I would do as Marshenko suggested, and then have some individual HA's available, just so you can present them to the auditor as evidence of a Corrective Action in progress if the auditor asks.

 

Moving forward, I'm assuming that one of the reasons the previous people grouped things is, hopefully, because they are similar in their inherent hazards. If that's the case, it should be fairly simple and quick to just copy the HA and insert the individual material name. You are still going to have to review the product specs to be sure, but hopefully it should be a fairly painless process.

 

Marshall

I also like Marshenko's idea.

 

Do you know if you are getting the same Auditor that has done the previous audits, if so and the plan was accepted the last around -- well, you know where I am going with this and then right after the audit get to work on your plan for your plan.

 

New Auditor but one who seems more in line with our needs than the previous.

I see no problem in grouping RM together if they share the same hazards, same processes...etc. Especially if you have 500 RMs. I previously did that in more than one company and no auditor had any problem with it. 

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Hi Ashley,

 

I'm vaguely curious as to which clause in SQF8 Manufacturing Code (Lvl 2 no longer exists as such) you are currently responding to ?

 

I cannot see any specific request for a separate "Raw Material hazard Analysis" per se although I appreciate such will always be required within an initial "chunk" of a typical integrated  HACCP Plan (eg as noted/further sub-linked  in Post 4 of the thread linked below).

 

Or is yr OP a response to clause 2.8.1.1.i which requests a "risk analysis" as responded to, for example, by the mega-grouped example in this post -

 

https://www.ifsqn.co...ent/#entry60234

SQF Food Safety (Level 2).  The last auditor spent so much time concerned on allergen cross contamination on the floor, that I'm guessing his look at the HACCP plan was a quick one, and maybe focused on Process HA (my last one at a previous place focused on Process vs RM HA).

 

It's a new auditor this time around.  The last one was banned from the facility after the last audit.  

 

Hi Ashley, I am a little curious about when you mentioned the last auditor was banned from the facility, can you perhaps share what happened if it's okay? 

Hi Ashley,

 

I'm vaguely curious as to which clause in SQF8 Manufacturing Code (Lvl 2 no longer exists as such) you are currently responding to ?

 

I cannot see any specific request for a separate "Raw Material hazard Analysis" per se although I appreciate such will always be required within an initial "chunk" of a typical integrated  HACCP Plan (eg as noted/further sub-linked  in Post 4 of the thread linked below).

 

Or is yr OP a response to clause 2.8.1.1.i which requests a "risk analysis" as responded to, for example, by the mega-grouped example in this post -

 

https://www.ifsqn.co...ent/#entry60234

 Hello Charles,

 

I am referring to 2.4.3.8- "Shall identify and document all food safety hazards that can reasonably be expected to occur at each step in the process, including raw materials and other inputs".

 

I am always been taught, and guided into the idea that each R.M had to be spelled out in the HACCP plan, because some in the same category can be from different vendors, countries, have different processing etc.

 

If I'm operating on outdated knowledge or practices I'd love to know because I would hate to spend weeks of work that I can use otherwise.

 

For my FSMA plans I've grouped them together, as I was also under the impression that was accepted for those.

 

Ours are separate because I came into that format, and that's also what I have always done. 

I see no problem in grouping RM together if they share the same hazards, same processes...etc. Especially if you have 500 RMs. I previously did that in more than one company and no auditor had any problem with it. 

 

I don't think this would be bad either - however, if you have an ingredient list and can easily group "like ingredients" than the RA/HA would be as simple as copy/paste for each individual input and leave zero doubt.

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Hi Ashley, I am a little curious about when you mentioned the last auditor was banned from the facility, can you perhaps share what happened if it's okay? 

 

From what I gathered there was a quite a difference in personalities between the auditor (younger) and QA Man (older) and both argued to show how much they knew.  The auditor went beyond that and despite the fact that they obtained a passing score with no need for a surveillance audit, he made more suggestions and did a lot of consulting than what should have happened.  He wanted (from my deduction of the notes) a total re-do of the facility and structure.  He insisted upon re-organizing areas because he didn't like them- didn't like how non allergens were grouped made it sound like it went against the code if like groups weren't kept together, adding another building  because he thought it felt too crowded during the busy season, he wanted a change of clothing after almost every single batch produced because they were dry powdered allergens involved in some formulas etc.  He wanted them to do away with all of their current packaging and start anew without foil pouches so that a metal detector could be utilized on all product, even though no current need existed.

 

Not sure if he was having an off day, over-audited, or needed to prove himself but I'm pretty understanding of auditors sticking to the code, but I think he over-reached?

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From what I gathered there was a quite a difference in personalities between the auditor (younger) and QA Man (older) and both argued to show how much they knew.  The auditor went beyond that and despite the fact that they obtained a passing score with no need for a surveillance audit, he made more suggestions and did a lot of consulting than what should have happened.  He wanted (from my deduction of the notes) a total re-do of the facility and structure.  He insisted upon re-organizing areas because he didn't like them- didn't like how non allergens were grouped made it sound like it went against the code if like groups weren't kept together, adding another building  because he thought it felt too crowded during the busy season, he wanted a change of clothing after almost every single batch produced because they were dry powdered allergens involved in some formulas etc.  He wanted them to do away with all of their current packaging and start anew without foil pouches so that a metal detector could be utilized on all product, even though no current need existed.

 

Not sure if he was having an off day, over-audited, or needed to prove himself but I'm pretty understanding of auditors sticking to the code, but I think he over-reached?

 

Thank you Ashley! I appreciate you sharing that! Because I was having problems with a previous auditor as well so I wanted to see what other reasons companies may ban their auditors for.

 

Looks like he was, in fact trying to prove a point. Some auditors don't understand that their main sole purpose is to visit the company and AUDIT. Go through the code and just point out NCs esp ones that are MANDATORY and are clearly in the code! 

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I was an SQF Auditor before becoming an SQF Consultant.

 

I did professional auditing for about 15 years and then for 7-8 years was one of the first SQF Auditors in the states.

 

Had a wonderful mentor when I started auditing hotels and restaurants years ago - he said "As an Auditor you are basically a skilled reporter, you are not a consultant - remember that!"

 

I did and never crossed the line - no, not once.

 

It sounds like the one that visited the facility and got banned not only crossed the line, but should have left auditing due to burnout, which happens a lot.

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 Hello Charles,

 

I am referring to 2.4.3.8- "Shall identify and document all food safety hazards that can reasonably be expected to occur at each step in the process, including raw materials and other inputs".

 

I am always been taught, and guided into the idea that each R.M had to be spelled out in the HACCP plan, because some in the same category can be from different vendors, countries, have different processing etc.

 

If I'm operating on outdated knowledge or practices I'd love to know because I would hate to spend weeks of work that I can use otherwise.

 

For my FSMA plans I've grouped them together, as I was also under the impression that was accepted for those.

 

Ours are separate because I came into that format, and that's also what I have always done. 

 

Hi Ashley,

 

Thanks reply.

 

My main point was regarding a separated raw material hazard analysis. This was common practice in older style haccp plans but i think an integrated format is now more usual and, IMO, easier to read.

 

afai can see, SQF in clause 2.4.3.8 leave the format up to the auditee.

 

I also don't get why SQF request a separate risk analysis in 2.8.1.1.i since this data would usually be already detailed in the haccp plan.

 

Excessive duplication IMO.

 

An example (excel) of an integrated format is here -

 

http://www.ifsqn.com...ge-7#entry50651

 

PS - a few of the many threads after searching for "grouping" -

 

https://www.ifsqn.co...an/#entry139684

https://www.ifsqn.co...ts/#entry134961

https://www.ifsqn.co...ls/#entry134294

https://www.ifsqn.co...art/#entry92909

Ashley,

You have not mentioned which industry you are into??,

 

But in my view, grouping of RM can be done provided the source and method of processing of RM is same, example i have grouped Whole milk powder and skimmed milk powder into one as the source and method of drying is same for both except fat removal process in skimmed milk powder.

 

If you group RMs and do hazard analysis for each group, the auditor may ask for Justification fro grouping. As some of the RMs may have been manufactured in the facility where allergens and other kind of RMs are manufactured or handled and sources of RM may be different such as plant, animal or mineral source. 

 

Regards

Mahantesh

Grouping RM is not an issue for SQF standard so long as you can readily identify all hazards posed by the group of raw materials.

 

I was QA Manager at a former facility where we produced flavors and also fruit bases.  We had over 3,000 raw materials and over 1,000 finished products.  I grouped raw materials together by their inherent known and possible hazards.  If a raw material in a group had specific allergens or sensitive agents those were spelled out for that raw material in our raw material registry.

 

Not once did our hazard analysis come up as an issue in our SQF audits.

 

As others have said, you have the flexibility to format and practice how you wish, just need to ensure you identify the hazards and can show your analysis is adequate.

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Just a re-cap for all:

Our unannounced audit ended up happening just 2 and a half weeks after this conversation :shutup:  and I had little time to un-group critical food groups (spices mainly) created by the previous QAM.  I went with what several above suggested and that was to include this as needing corrective action on our internal audit.  The auditor actually was okay with this, but still gave me a point when it came to my food fraud mitigation plan because I had a similar issue as above (QAM grouped everything into very broad categories) and several spices we purchase from China have known adulteration issues. 

 

Luckily in the time since the audit (we got 11 minors but we were thrilled with that given my short time with the company and previous high turnover in the position) I have been able to breakdown the spices and work on them.

 

The auditor was fine with the other categories being grouped, but to give special attention or break apart raw materials with known hazards separate from the category they may be grouped in.  

 

Thanks for the help, all!!

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Just a re-cap for all:

Our unannounced audit ended up happening just 2 and a half weeks after this conversation :shutup:  and I had little time to un-group critical food groups (spices mainly) created by the previous QAM.  I went with what several above suggested and that was to include this as needing corrective action on our internal audit.  The auditor actually was okay with this, but still gave me a point when it came to my food fraud mitigation plan because I had a similar issue as above (QAM grouped everything into very broad categories) and several spices we purchase from China have known adulteration issues. 

 

Luckily in the time since the audit (we got 11 minors but we were thrilled with that given my short time with the company and previous high turnover in the position) I have been able to breakdown the spices and work on them.

 

The auditor was fine with the other categories being grouped, but to give special attention or break apart raw materials with known hazards separate from the category they may be grouped in.  

 

Thanks for the help, all!!

A good result @AshleyQA.

Thanks for bringing up the topic and following through with the end result.

It's a good prompt for me to have a look at our own HACCP plan (over 3000 raw materials) and see what improvements can be made based on the discussions in this thread.

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