52 replies to this topic

[Simon]

For a change I would like to ask a question if I may.

I know we get lots of visitors to the BRC/IOP Forum from different packaging processes (glass, metals, paper, plastics, wood) and I would like to know some details on your HACCP (hazard analysis) especially the additional hazards you have identified (if any) over and above the requirements contained in the Standard.

If you have identified Critical Control Points please tell me what they are and how you control them? If you haven't identified any CCP's again please post as it will be useful information to me.

Thanks for your help,
Simon

[Laura]

Hi
I have just revealuated the HACCP system at the company I work for and we have moved away from identifying CCP's. Instead we have completed a complete risk assessment of all process steps (similar to an FMEA) and then set a grading system for the risk score.
From this we have set the control level and documentation level that must be in place for each grade. This is seen to be more useful as an aid to setting an audit schedule.

Thanks
Laura

[Simon]

Hi Laura,

I'm interested in anything different; would it be possible to post maybe just a part of it? So that I can understand a little more.

Regards,
Simon

[Charles Chew]

Laura,

IS the system currently certified to any standard?

Charles Chew

[Laura]

Hi
I have just revealuated the HACCP system at the company I work for and we have moved away from identifying CCP's. Instead we have completed a complete risk assessment of all process steps (similar to an FMEA) and then set a grading system for the risk score.
From this we have set the control level and documentation level that must be in place for each grade. This is seen to be more useful as an aid to setting an audit schedule.

Thanks
Laura

Hi Simon
I have attached a copy of the guidlines and a section from one of the processes that has been assessed. On the excel sheet the guidlines for the risk scoring and the grading guidlines are in the word document

This is in the throws of being developed so any further thoughts from you are well received.

Thanks
Laura

Attachments corrupted - removed from post

New links added 10022008 / Charles.C -

 laura_Copy_of_saferpak_dwl_140706___risk_assess.xls   19.5KB   548 downloads
 laura_saferpak_dwl_140706_risk_cat.doc   26.5KB   391 downloads

(also available in Ch.C post of ca.09022008 later in this thread (pg2))

[joyfranks]

Hi Simon
I have attached a copy of the guidlines and a section from one of the processes that has been assessed. On the excel sheet the guidlines for the risk scoring and the grading guidlines are in the word document

This is in the throws of being developed so any further thoughts from you are well received.

Thanks
Laura
The system is certified to the BRC Iop cat B
Thanks

Hi All,

Most packaging companies do not have CCP's as defined by codex HACCP as it was designed for food. There are some processes that have CCP's were filtered air or water is used is an example. The problem is most packaging companies think they have to have CCP's when really they are part of the pre requisite systems. There is a training course availble which has been written for the packaging industry in HACCP for non food industries. If anyone would like details let me know. Any good auditor, as long as you have assessed the risks will accept the concept of GMP control points rather than critical.

regards

Joy

[Charles Chew]

Most packaging companies do not have CCP's as defined by codex HACCP as it was designed for food.

- AGREE!

Any good auditor, as long as you have assessed the risks will accept the concept of GMP control points rather than critical.

Speechlessly on the same page with you.

[okido]

Goodday,

We use more or less the system as Laura does and are certified BRC IoP B.
The approach from Laura is very structured for process steps.
We made this same structured approach for chemical, biological, and physical hazards.
I wonder if you did the same Laura?

Okido,

Remember to share good fortune with your friends.

[Simon]

Hi Laura,

Many apologies for not getting back to you sooner. I really like the method you have chosen and the fact it covers Quality as well as Hygiene failures is very sensible. Looking at the requirements for a Hazard and Risk Management System in Section 3 of the BRC/IOP Standard along with some pedantic nit-picking my comments and questions are:

- I assume you have a validated process flow diagram in place.
- You could possibly clarify 'hygiene' further (perhaps add another column) for whether the hazard is Microbiological (M), Physical (P), Chemical ©.
- In your recommended actions table you use the words (A) "frequently audited" and (B) "regular audits" - you could be more specific on the required frequency of audits for each level.
- To get an "A" critical risk rating the hazard must score above 50 so let's take this example:

Example Hazard Analysis:

Frequency = 5 (very high failure is almost inevitable)
Severity = 5 (Very serious - potential for civil litigation, non-compliance with government regulations. Will cause serious loss of manufacture and serious impact to customer resulting in loss of business and high commercial impact)
Detection = 2 (Current controls have a good chance of detecting the failure)

F X S X D 5 X 5 X 2 = 50 = High Risk

Are you happy that having only a 'good chance' of preventing such a serious failure does not require Critical Risk controls?
I do like it though Laura - well done!
Have you heard me - I sound like a flippin teacher.
Regards,
Simon

[Bonno]

Dear Laura,

I like some of the angles that you have taken but I must admit that personally I shy away from any system where a 'score' is obtained.
I know that this is a highly used method in a number of fields (Quality, Hygiene, Environmental & H&S etc.), but I always have concerns when the 'Level of Risk' is then decided as I always manage to find some loop-holes where 'borderline' scores do not get the attention they need due to their risk being 'downgraded'.

I know there are grey areas in all systems, I know that there is no perfect method and I would always recommend that people go with the method of grading that they are comfortable with (and feel most comfortable justifying) - just thought I'd add my opinion.

Again, I do like some of your angles that you have included and it is always good to see how others approach things.
If we don't explore we never find anything new.

Bonno

[ltl]

Hi Laura, I would like to find out more about the system you are talking about - not using CCP? Are you then not going to implement HACCP?
Thanks
Thea

Laura,

IS the system currently certified to any standard?

Charles Chew

[baikalin]

Maybe I'm way off here because I'm just dealing with the preliminaries of preparing for a HACCP audit in a company that has never done any such thing.

I'm using points that I see potential problems occurring as CCPs

For example: Unloading our raw materials: They come in a 18 wheeler and are unloaded by hand. The workers lean on the truck while someone else literally throws the bags of resin to their shoulder. Risk is bags getting cut or punctured on the dirty truck which would contaminate our raw materials.

I'm not having trouble establishing the CCPs... I'm having more trouble identifying critical limits with any detail beyond "yes it did happen" "no it didn't" Anyone have any tips on this?

[MartLgn]

I'm using points that I see potential problems occurring as CCPs

Hi Baikalin.

It seems to me that you are not taking a strictly HACCP ( Codex Alimentarius) approach to assessing the risks on your site. If you follow the HACCP methodology correctly you may find that what you thought are CCP's are not. Many packaging manufacturers find they have no CCP's as such and that their prerequisite programmes (GMP, training Housekeeping, work instructions etc) control such risks that exist. I would suggest that the manual unloading of a vehicle is an area where good practice could control most risk of material contamination in conjunction with a procedure for dealing with any damage that does occur before the material is used in your products.

Good luck with it.

[baikalin]

Hi Baikalin.

It seems to me that you are not taking a strictly HACCP ( Codex Alimentarius) approach to assessing the risks on your site. If you follow the HACCP methodology correctly you may find that what you thought are CCP's are not. Good luck with it.

Thanks for pointing out my error... I was getting a little cocky this morning before I started digging deeper and finding more and more things that made me question my assumptions.

Anyway, can you explain to me what the main concept keeping my raw material unloading example from being used as a CCP? Is it that it is already supposed to be controlled by other factors, that it is hard to create critical limits for, or that it isn't really documentable or that later on the problem (dirty raw materials) would be detected? Or any one of those things?

If there are no CCPs doesn't documentation of following policy become difficult? Or should one just establish checklists that must be monitored at different times checking different aspects of GMP？

Thanks much for your input. The more I think about it all, the more confused I become.

Caitlin

[Franco]

Instead we have completed a complete risk assessment of all process steps (similar to an FMEA) and then set a grading system for the risk score.

This is done to keep the output of the process within specifications.
Are you doing anything to improve the control of your process ?
I bet you are Laura.
Would you like to share with us the results ? Rgds. Franco

[MartLgn]

Anyway, can you explain to me what the main concept keeping my raw material unloading example from being used as a CCP? Is it that it is already supposed to be controlled by other factors, that it is hard to create critical limits for, or that it isn't really documentable or that later on the problem (dirty raw materials) would be detected? Or any one of those things?

If there are no CCPs doesn't documentation of following policy become difficult? Or should one just establish checklists that must be monitored at different times checking different aspects of GMP？

Hi Caitlin.


I assume that you are in the process of preparing for a BRC/IOP certification audit and are getting to grips with the Hazard analysis secion of the standard ???
I'll try and address the points you raised in order ....

1.I am not saying that your unloading process cannot be a CCP but rather that what you had said indicated that you had not followed the correct process to determine whether or not it was.

2. Ideally you should have operating procedures or work instructions designed to minimise the risk of material being damaged, these would be ideal candidates for a prerequisite program to your HACCP system.

3. If only being difficult to control and document was an excuse not to make a CCP we would all be so much happier ! unfortunately it isn't and if your Hazard Analysis showed that a process was a CCP then it must be controlled and documented no matter how dificult. It is an interesting point that you make about contaminated materials being detected later on, if youhad a procedure in place for inspecting material before use then this step could exclude the necessity of unloading as a CCP.

4. If there are no CCP's then there is no 'following' documentation, you would have the procedures that you use to achieve GMP and these would form the prerequisite programmes taht when followed ensure all risks are controlled to anextent that means you have no CCP's.


If this is your first foray into BRC and HACCP I would say that there is no universal right or wrong answers and you must assess your own processes as part of a proper Codex based HACCP program and do what is right for your site. As a packaging producers you should find that a well implemented prerequisite programme of GMP and hygiene procedures would result in very few if any geniune CCP's, the plant I am based at produces tens of millions paper based packages a year on 12 production lines for many of the biggest brands and we have 1 CCP.

[Simon]

Some of the good practice measures that one would expect to find in this area are having in place agreed written hygiene standards with your suppliers for the carriers they use. This specification should include their agreement to provide suitable clean vehicles that protect your product rather than contaminate it; they should also agree not to carry part loads that might contaminate your product.

You should have a documented incoming vehicle and load check against this specification. Any problems should be reported back to your supplier and corrective action taken. Turn unsuitable vehicles / dirty product away if needs be; they should soon get the message.

HACCP is a preventative system and these control measures should help to minimise the potential for product contamination in this area and also satisfy BRC/IOP requirements.

Anyway welcome to the forums Caitlin - feel free to ask further questions as you need to.

Thanks for your input Martin.

Regards,
Simon

[Charles.C]

Dear All,
Intriguing thread. I found Laura's scoring procedure very interesting as also Bonno's comment regarding the conceptual difficulty in accepting a numerical system for hazard analysis.

It should be emphasised that one of the primary intentions of the HACCP concept is to force the producer to examine his system so as to prioritize any observed health (usually) related risks. It was also originally assumed that the HACCP system would be highly evolutionary, ie regularly updated in the light of internal/external experience.
Initially HACCP plans may require a significant amount of process analysis / observation / interpretation / evaluation / discussion. The amount will depend on the specific system and its potential for impacting on receiver health issues. The original HACCP plans were loaded with sanitation CCPs as per Caitlin's idea however it was later considered more effective to separate these out ('pre-requisites') since they would be expected to be addressed in a basic GMP system already. This approach is debatable (see for example the recent salmonella incident in another thread on Cadbury's chocolate) but convenient (for auditors especially) and popular. Whatever, the size of the resulting plan is going to be related to the specific process, eg raw compared to ready-to-eat products. In some cases (countries) a semi-prescriptive procedure with model presentations is available where 'experts' have studied a range of typical ways to make products, eg USA / Canada for seafood / foods, not to forget this web-site itself for packaging.
Regarding Laura's scoring system, never used FMEA however I am bit uncertain as to the inclusion of the 'detection' function (usual HACCP procedures restrict to 2 parameters). One problem with the scoring system is how to weight the different risks. Laura's method seems initially unweighted which is convenient but IMO questionable. I liked the inclusiveness of the procedure but it looks to require a lot of deliberation / documentation?. The same problems occurs with non-scoring techniques where qualitative (judgemental) probability assessments are still required (importation of new food species has generated a lot of good business for health/environmental risk assessors). The Codex HACCP tree presents a logical question chain while permitting any, presumably validatable, risk assessment system to be used, qualitative or quantitative.
Auditors in my experience are reluctant to deviate from expected patterns which they have met before which can make it difficult to include items which are, at least IMO, debatable. The most frequent CCP arguments I have had with auditors are (a) including raw material control in the HACCP plan proper (not as a pre-requisite), (b) not including metal detectors where I considered there was no significant risk of metal contamination, © including traceability date-coding aspects.
Rgds / Charles.C

[Simon]

The system is certified to the BRC Iop cat B
Thanks

Altough Laura confirms the system is BRC Certified after reading through the thread again I cannot see how. The methodology clearly does not address PCM hazards; and the BRC Packaging Standard 3.1.1 states:

The company shall conduct a formal hazard analysis on the production process, considering microbiological, foreign objects and chemical contamination...
So how does that work?

[MartLgn]

Altough Laura confirms the system is BRC Certified after reading through the thread again I cannot see how. The methodology clearly does not address PCM hazards; and the BRC Packaging Standard 3.1.1 states:

The company shall conduct a formal hazard analysis on the production process, considering microbiological, foreign objects and chemical contamination...
So how does that work?

Although Im not a fan of score based risk assesment (I think they lend an unwarranted rigidity to what is essentialy a subjective process) , I think that Laura has a good case to convince an auditor that her system meets the requirements of the BRC/IOP standard assuming. The hazards listed as hygiene could be P,C or M and so long as each possibility is considered when calculating the score then the requirement has been met. I don't think it is significantly different in this respect to a Codex based HACCP system whereby the process of arriving at a CCP does not have to be recorded (although it may a good idea to do so) within the HACCP documentation.

I can't help but feel it would be better if BRC/IOP would just come out and prescribe HACCP as the required hazard anaylsis methodology instead of the current almost but not quite requirements currently in the standard but with ISO22000 circling ever lower I doubt somehow they will

[Simon]

I think that Laura has a good case to convince an auditor that her system meets the requirements of the BRC/IOP standard assuming.

Looks like she's already done that job.

I can't help but feel it would be better if BRC/IOP would just come out and prescribe HACCP as the required hazard anaylsis methodology instead of the current almost but not quite requirements currently in the standard but with ISO22000 circling ever lower I doubt somehow they will

Yes I agree with you Martin it's totally bonkers, the committee must have spent weeks searching for an alternative to the dreaded H word. How about HARMS - Hazard And Risk Management System, or would that be a paradox?

Simon

[MartLgn]

the committee must have spent weeks searching for an alternative to the dreaded H word. How about HARMS - Hazard And Risk Management System, or would that be a paradox?

Simon

I suspect if we asked the Technical Committee they would say that they avoided the term HACCP as a foresighted acknowledgement of the fact that in many packaging operations CCP's as prescribed in Codex do not exist They would also proudly point out that the fact that section 3 of the standard made it into issue 2 of the standard virtually untouched proved how right they were !

I don't know if anyone else has experienced the same thing but we have major customers whose own technical standards require us to have a Codex based HACCP system and on the other hand the BRC/IOP standard requires a Hazard Analysis which doesn't have to comply with Codex It is for this reason that I would prefer the BRC/IOP standard to prescribe HACCP as whilst many packaging companies will find no CCP's the Codex methodology covers all requirements of section 3 of the standard whilst giving the customer the HACCP system they require and everbodys happy. Our Hazard Analysis consists of a HACCP study with only one CCP in a binder marked 'Hazard And Risk Analysis Study'

I quite like the HARMS idea, some of the best Acronyms have slightly innapropriate conotations. Im not sure the auditors would be too keen on asking how we carry out HARM though

[Simon]

I suspect if we asked the Technical Committee they would say that they avoided the term HACCP as a foresighted acknowledgement of the fact that in many packaging operations CCP's as prescribed in Codex do not exist. They would also proudly point out that the fact that section 3 of the standard made it into issue 2 of the standard virtually untouched proved how right they were!

You're right but I think we agree this has confused people.

I don't know if anyone else has experienced the same thing but we have major customers whose own technical standards require us to have a Codex based HACCP system and on the other hand the BRC/IOP standard requires a Hazard Analysis which doesn't have to comply with Codex. It is for this reason that I would prefer the BRC/IOP standard to prescribe HACCP as whilst many packaging companies will find no CCP's the Codex methodology covers all requirements of section 3 of the standard whilst giving the customer the HACCP system they require and everybody's happy. Our Hazard Analysis consists of a HACCP study with only one CCP in a binder marked 'Hazard And Risk Analysis Study'

Oh so you have a HARAS system as well Martin - I like it, but doesn't that come under Health & Safety?
Even when you have a definitive standard such as the BRC/IOP it is still never quite definitive enough for some customers. It has to be said BRC/IOP has done a pretty good job in homogenising (correct word???) customer specific requirements, reducing the number of audits etc. but it can only ever hope to minimise. I wonder do you track the number of customer audits you had pre and post BRC/IOP?

Regards,
Simon

[MartLgn]

Oh so you have a HARAS system as well Martin - I like it, but doesn't that come under Health & Safety?

Not on my watch it doesn't ! I thought HARAS tied in well with the wording of section 3 of the standard.

Even when you have a definitive standard such as the BRC/IOP it is still never quite definitive enough for some customers. It has to be said BRC/IOP has done a pretty good job in homogenising (correct word???) customer specific requirements, reducing the number of audits etc. but it can only ever hope to minimise. I wonder do you track the number of customer audits you had pre and post BRC/IOP?

I remember harmonisation being a key selling point when we embarked on the project to achieve certification, the 2 years following we received roughly the same number of customer audits and this year so far we have had 6 already as oposed to 4 in the whole of 2005 (and a further 2 in the diary) ! I suspect some of it is down to the major retailers pushing their suppliers for ever greater accountabiility but I can't help wondering if some suppliers think we become complacent once we have another years certification in the bag

[okido]

We also moved from decision tables to score based risk assessment for CP and CCP's. The decision tables gave to much room for interpretation and unwanted discussion. Definitions of score based systems are straight forward and leave less room for discussion.
Auditors over the last 10 years always appraised the methodology.
Mainly because we showed that we gave it a good thought and the method is well documented.

Remember to share good fortune with your friends, Okido