9 replies to this topic

[Charles.C]

Dear Simon

The site looked a little sparse so this should help. Wasn't quite sure where to put it so I stuck with documentation, please feel free to move if you prefer.
Have noticed yr very recent introduction of various high tech.(to me anyway) techniques to the forum concerning process analysis / representation tools. This happily coincided with my seeking (low tech.) help on this subject.
I am in process of compiling a Quality Manual (BRC food) in parallel with writing procedures and have been reluctantly sucked into exploring the intricacies of the so-called 'process approach' after noticing the increasing interest / emphasis at Messrs ISO and inasmuch as the specifiic chunk referring to this in BRC is obviously a direct borrow from ISO albeit with some codicils unused (eg ISO demands the process interactions be described within the Quality Manual itself whereas BRC seemingly does not - as far as I can see anyway).

I have encountered some (I think) contradictions in my literature scouring and would like to request input/ideas if possible -

(1) What activities are classifiable as processes? I appreciate the basic requirement is to demonstrate the existence of a situation where you have [input --> activity --> output] however the interpretation of I / O seems blurred. For example I met the statement that Quality Assurance is not a process along with a few of the other famous 20 elements of the old ISO (eg inspection), seemingly (my interpretation) since there was no tangible transformation in comparison to, say, production. I don't see what's wrong with[ materials / information / other intangibles --> // evaluation activity // --> conclusion /acceptance / rejection / documents] generating a valid process situation. Contrariwise I noticed QA appear on a couple of other maps under the slightly denigratory guise of 'Support Process. ' Can you / any other gurus present clarify this situation ? This reminds me of the early days of HACCP where the question 'what is a genuine CCP' reigned supreme - and remains unanswered in many ways IMHO. Then people had CCPs everywhere and I can see that is a possible fault in my above reasoning - all activities will be interpretable as processes (aargh). Perhaps my question should have been - when are activities not classifiable as processes and why ?

(2) What do BRC expect as an answer to their request for an identification of processes / sequencies / interactions ?. I noticed that the examples of ISO 9k2k Q.manuals on the net were generally similar to yr site example containing a 1 page picture, sort of deriving from the ISO displayed diagram / loop. Some of the maps did not have any procedure refs on them at all so I presume the maps were considered sufficient in themselves (a demonstration of understanding of the concept is sufficient ??). I appreciate that I am talking a minimalist solution here but is this (1 picture) sufficient documentation-wise to fulfil the requirements (addendum - do the auditors nonetheless expect to meet a well-clued up process oriented QMS representative or do they not have a mandate to follow this aspect ?). I have no objection to self-education regarding new tools but I would like to possess a bit of certificate paper first by the most pragmatic route and then become a system thinker.


(3) To demonstrate management committment etc I wanted to include GMP and HACCP activities somewhere on the interaction picture (I'm assuming both these items can be classified as 'Processes' as referred above but if you don't agree with this please comment). However I am not sure if they should be classified as a further 'product realisation' entity such as a process called product safety process with links to all aspects of production / environment /personal hygiene (ie with GMP as a sub process of HACCP ?) or a Resource (hardly seems appropriate for the mighty HACCP) or what. Would appreciate some input if you have seen any examples of other peoples' thinking in this respect (ie such as where they put them in the picture).

Long winded as usual but I hope of interest. Any comments very welcome / very grateful.

Regards to all (especially those who are not on holiday like myself)
Charles.C

[Simon]

What activities are classifiable as processes?  Perhaps my question should have been - when are activities not classifiable as processes and why?

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Hi Charles,

Very interesting questions. Can it be that EVERYTHING that's do-able is a process? Eating, drinking, making, selling, billing, auditing, inspecting, breathing, being born, living, dying are all processes. But I certainly wouldn't like the job of documenting them. I would be interested in hearing of activities that could be excluded.

If you accept the above then it follows that all business activities are processes including QA. What you have to do is identify and manage the key processes e.g. the ones that are focussed on meeting the needs of the customer.

A simple high level process map could look like:

Marketing - Sales - Purchasing - Production - Logistics - Billing

That's the sequence sorted and there will be lot's of additional interaction between them over and above the linear. You can drill down into each element to reveal sub processes and so and so forth. So where does QA, human resources, information systems, document control and improvement fit in? Hopefully they are inherent within each of the processes. With HACCP and GMP probably more aligned to purchasing, production and logistics.

Although I can't give you an example drawing myself I would suggest you keep it simple and make the system relevant to your business.

I know some of the members of these forums work with the BRC Global Standard - Food. Hopefully they will be able to tell you what auditors are looking for and perhaps show you how they have addressed the process requirements of the BRC.

Hope this helps.

Regards,
Simon

[Charles.C]

Dear Simon,

Sorry, I hadn't realized that the BRC packaging standard had omitted the BRC food paragraphs concerning processes / sequences / interactions. Looks like good luck for you but maybe coming at your next revision if the BRC gnomes are following this forum. I appreciate yr tackling the questions regardless and thanks yr comments. The elsewhere silence probably indicates other readers are staying as far away as possible from this topic and I certainly can't blame them for that.

Actually the ISO suggested process segmenting, is into (a) Management Responsibility, (B) Resource Management, © Product Realisation and (d) Measurement, Analysis and Improvement. If I was a Production person I would probably regard HACCP as a support process within Product Realisation (maybe linked to the sub-process of production planning, eg via hazard analysis of product design / procurement / production /etc ) but as a QA person this seems rather defeatist (where is the QA box ?). Sanitation related issues are perhaps a mixture of human / facility resources (eg locating workers who can be trained not to sneeze etc). I will plod on.

May I take the liberty of adding another very short query which I would imagine will apply to both standards. A few months ago I was chatting to a consultant (ISO/BRC/etc) about the interpretations of English text statements in the food standard. Some were reasonably sensible like 'shall' means you have to do it (somehow), documented = documented, however he came up with one I found highly questionable, viz. wherever the standard has the magic words 'in place' concerning some subject, the interpretation for the auditor is that an appropriate documented procedure is mandatory. If you follow this logic in the food BRC you end up with a nice list of procedures. Have you encountered anything like this? (as a comparison I understand that ISO expects that where it says documented it requires a documented procedure, period. This yields a minimum 6 procedures, the rest is up to the QMS management).

Regards to all
Charles.C.

[Simon]

Sorry, I hadn't realized that the BRC packaging standard had omitted the BRC food paragraphs  concerning processes / sequences / interactions. Looks like good luck for you but maybe coming at your next revision if the BRC gnomes are following this forum.

<{POST_SNAPBACK}>

Hi Charles,
The BRC/IOP Packaging Standard is currently being revised and is due to be published later this year. No doubt it will follow the same path as the BRC Food Standard with regard to the process approach.

Oh and BTW the packaging standard also uses "in place" e.g. 'A formal Hazard and Risk Management system shall be in place…..'

Regards,
Simon

[Charles.C]

Dear Simon

Thks yr comments. I am sorry that once again I may have succeeded in hiding the intent of my question in a mass of verbiage. If you have the patience I will try and clarify.
The previous ISO9000 (1994) was considered flawed partly due to its requirements inadvertently (?) causing severe over-documentation (jumbo quality manuals / procedures for everything in sight). ISO9k2k specifically addressed this issue so as to try to promote a reduction in individual written procedures and documentation.
I counted about 20 instances of the phrase 'in place' in BRC food standard (no reference to this phrase in the Glossary). Some of these overlap topics (eg (1) cleaning schedules shall be in place, (2) systems shall be in place to minimise accumulation of waste. I refer to both of these topics in our 'General Hygiene Regs' but are we really expected to have a specific procedure for both?. Another section would seemingly require a specific procedure for transport vehicle breakdown.
Ironicallly the food HACCP section has no 'in place' (I think) but has requirement to 'establish documentation' and quite rightly so!
I just noticed there are 16 individual procedures in yr sample Hygiene Manual. I pray that this is just a choice of presentation style and not related to the above ?

Confused in BRCland.

Regards
Charles.C

[Simon]

Thks yr comments. I am sorry that once again I may have succeeded in hiding the intent of my question in a mass of verbiage.

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Hi Charles,

Why use 3 words when you can get away with 10 - the BRC did! :D

Anyway you're 'in place' theory provoked me to take a closer look at the BRC/IOP Packaging Standard.

I discovered throughout the Standard ‘in place' is used liberally not only within the requirements but also in the ‘Statements of Intent' and the ‘Recommendations on Good practice'. But for the purpose of this we'll concentrate solely on the requirements and I've listed below all of the clauses that contain the term ‘in place'.

As you can see ‘in place' is used in variety of ways and is used in conjunction with: systems, procedures, documented procedures, effective precautions, controls and guidelines. And my favourite - advisory sign shall be ‘in place'.

I believe you asked does ‘in place' mean a documented procedure is required.

Quite clearly you can see that sometimes it does and sometimes it does not. However, there are inconsistencies, for example some clauses require a procedure to be in place and some require a documented procedure.

A question then: When does a procedure need to be documented?

If a BRC auditor asked for example:

Clause 4.2.6 states that a procedure shall be in place to ensure obsolete documentation is rescinded and, if appropriate replaced with a revised version. Can you show me evidence of this?

Do you get a tick in the box if you can demonstrate through records that you operate an effective document control system, or is a documented procedure explaining how the system works required?

I would say to the letter of the standard you could argue that unless it actually states ‘documented' procedure, it's entirely up to you whether you decide for ‘good business sense' to document or not to document.

Will documenting the procedure for example help:

 Train employees
 Communicate instructions
 Aid third party and customer audits
 Answer Supplier QA Questionnaires
 Whatever

‘IN PLACE' CLAUSES

4.2.6 A procedure shall be in place to ensure obsolete documentation is rescinded and, if appropriate replaced with a revised version.

4.4.1 Companies shall provide written guidance to relevant staff regarding the type of event that would constitute an 'incident' and a documented incident reporting procedure shall be in place.

4.4.3 An effective documented 'Product Recall' procedure shall be in place. The procedure should be tested on a pre-determined frequency and results retained for inspection. The procedure should take place on a minimum annual basis.

4.4.4 Clear procedures for the control of out of specification, non-conforming materials, including rejection, acceptance by concession or, regarding an alternative use, shall be in place and understood by all authorised personnel.

4.5.1 The supplier shall have a system in place to trace all materials from source to finished product at any point in time where possible based on hazard analysis.

4.6.2 To prevent contamination, procedures shall be in place to appropriately segregate raw materials, work in progress and finished products.

4.7.1 Nominated adequately trained personnel shall carry out internal auditing at specified regular intervals. A documented audit procedure shall be in place that will include the frequency of internal audits. The frequency shall be based on hazard analysis. Where internal auditing has indicated that corrective action is required, action indicated and taken shall be documented.

4.11.1 Procedures shall be in place to ensure reliability of test results.

5.3.10 Effective precautions shall be in place to prevent external airborne pests entering by way of ventilation openings. Where roof vents are present they should close automatically when required. Such vents should be adequately insect screened.

5.4.6 A planned preventative maintenance programme for plant and machinery shall be in place and shall address the risks from contamination.

6.1.2 A written policy and documented controls on non-production glass and brittle plastics shall be in place. Any product that has become contaminated shall be segregated and disposed of.

7.3.2 Advisory signs shall be in place to prompt hand washing. Adequate facilities for hand drying shall be provided.

7.7.3 Self-care shall be permitted, provided adequate controls and appropriate guidelines are in place.

7.8.3 A programme of refresher hygiene training shall be in place

How's about that for verbose.

Regards,
Simon

[Charles.C]

Dear Simon,

Many thanks yr scrutineering efforts. As you say, a right pot-pourii. I suppose it could be different authors also. Perhaps luckily, my conclusion agreed with yours so maybe I can call your post a validation (or verification but that's another story).
I do hope that anyone who may have experienced a contrary auditorial experience will post in.
Somewhat intrigued by 7.7.3, Self-Care, seems you need packaging for this one.

Regards
Charles.C

[Simon]

Somewhat intrigued by 7.7.3, Self-Care, seems you need packaging for this one.

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Nah, it doesn't mention anything about packaging. I wonder can you really have an effective 'self-care' system for overall cleaning? Even with guidelines in place, I reckon it'd be a nightmare to manage.

Does anyone operate a self-care system?

Regards,
Simon

[Charles.C]

Dear Simon,

Apologies for having misdirected again. In my previous post my closing comment was referring to the food / packaging standards since the self-care requirement doen't appear in food standard and I was wondering what the heck it was referring to. Now I deduce that it refers to checking cleaning somehow but the implementation remains obscure as indicated yr post.

Regards
Charles.C

PS. Since I am in SE Asia it was rather nice to see we had more Olympic golds (1) than UK a few days ago but probably not for long.

[Simon]

PS. Since I am in SE Asia it was rather nice to see we had more Olympic golds (1)  than UK a few days ago but probably not for long.

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Yes you better just watch out Charles C. Team GB are certainties for Gold in the ‘Underwater Belly-dancing' and the ‘Synchronised Rowing with Clogs on' - and who'll be laughing then eh?

Regards,
Simon