Flow Diagram - A document or a record?

Dear All!

Do somebody have an idea why ISO 22000 states that verified flow diagram shall be maintained as record? Although it should be, IMO, treated as controlled document. The justifications for same are:

1- Its just like to make a procedure or any other document and get it approved (verified & signed).

2- Awareness of flow diagram should be communicated to process owners also and hence it should also be distributed to them. It means, distribution of flow diagram should be controlled.

3- During passage of time, flow of process needs to be changed or improved. It means flow diagrams need to be revision controlled.

Regards::

Hi Zeeshan,

I presume this is para 7.3.5.1

Is this the (current) practical reason for yr other, more general, recent thread which looks like a similar issue ?

( http://www.ifsqn.com...showtopic=13129 )

No problem but, if so, I will add a pointer on first for other posters to avoid duplication. I am interested to see any responses also.

Rgds / Charles.C

Does anyone encounter the auditor request some process control measure like changing sand filter, backwashing sand filter, chaning uv lightetc included into flow diagram??

Hi Charles,

No, IMO, this issue is somewhat different as compared to that I have initiated referred by you.

Actually, I have raised a question that why standard has stated that verified flow diagrams shall be maintained as record. Flow diagrams are generally treated as document not record. If some body is claiming that after verification a verified document becomes as record than an approved procedure or a verified work instruction should also be treated as record as these contained records of approval and verification. Hope I have pictured the actual problem.

Regards:

Hi to all!

No body is attending this question. .

Dear Simon, would you please help me to revive this issue.

Regards:

zeeshan.

Hello Zeeshan:
Did your auditor ask you to define the terminology of 'record' and 'controlled documents'?

Part of the controlled documents with signature, is still a controlled documents even though it has the 'nature' of a record. You still need to follow your ways of controlling it [For me, most of the records are controlled documents except those that are not important or not belong to any systems in the company]

Process Flow is an important document. In my opinion, as long as you and the rest of the people in the company:-
(a) understand the process flow
(b) know the current revision number of this document
© know any changes made to the process flow
© know the storage area of this document, including the retention period and able to retrieve the obsolete 'old' process flow.
(d) know how to do when you circular this document and dispose the obsolete document
(e) etc
then the detailed definitions for the above are not so important any more.

Any comment from the forum members?

Hi, there

I havent read the other responses since your question.

What I have experienced is that when you set up a HACCP plan and you construct a flow diagram, they want the HACCP/Food Safety team to verify that flow diagram on site. Its literally walking through the plant and checking that the process flow is accurate. I had the HACCP team sign and date the document and file it with HACCP docs.

The flow diagrams that you put up in the plant, or that is part of the master file is controlled documents though.

Cheers
Bennii

Hi
not sure if this is what you are looking for (cann't remember where I got htis as I used as part of my CIEH level 3 HACCP in manufacturing assignment)

The flow diagram is document that is included within the Manual. However the verification is the record. In other words the evidence that the flow diagram is verified by the HACCP team is the record. I think the auditor is saying that the record of verification should be retained and protected like any other record.

Does this make sense?

The flow diagram is document that is included within the Manual. However the verification is the record. In other words the evidence that the flow diagram is verified by the HACCP team is the record. I think the auditor is saying that the record of verification should be retained and protected like any other record.

Does this make sense?

Thanks for reply!!!

Of-course it make a sense. Good justification Edward. Now I am clear as far as justifying the clause of ISO 22K.

Other part of my question also need your attention.

2- Awareness of flow diagram should be communicated to process owners also and hence it should also be distributed to them. It means, distribution of flow diagram should be controlled.

If distribution of verified flow diagram is to be controlled (IMO it should be) whether it make a sense to distribute a record just like controlled document?

Assuming that verification of flowdiagram is done by seeing the actual process and signing the flowdiagram as a record. IMO it looks awful to keep verified flow diagrams as a record and distribute copies of non-verified flow diagram (not containing verification signatures)

Regards:
Zeeshan

I think this is semantics. In my site, a record is a type of controlled document. We have several types (in fact I have a document type called "HACCP" of which the flow diagram is one.)

I don't think it's a problem. Both a record and a controlled document can be the same thing. Both need an issue number, date, who's approved it, name etc. and both need to be issued and printed copies controlled.

I don't know if that makes sense but I don't think there's anything to get worked up about!!!

I think this is semantics. In my site, a record is a type of controlled document. We have several types (in fact I have a document type called "HACCP" of which the flow diagram is one.)

I don't think it's a problem. Both a record and a controlled document can be the same thing. Both need an issue number, date, who's approved it, name etc. and both need to be issued and printed copies controlled.

I don't know if that makes sense but I don't think there's anything to get worked up about!!!

Dear GMO,

I accept your statement that "Both a record and a controlled document can be the same thing." but in many cases they are not. Both "Controlled Documents" and "Records" have different controls. Records need no issue number because they generally need not to be under revision control. That's why ISO 9001, 22K and other standards have separate clauses both for "Controlled Document" and "Records".

Regards:

I agree with GMO that records also need a revision number. If not, how are you going to ensure that people are using the current version and not the obsolete one???

Dear All,

You can cetainly find support for almost any option regarding the necessity, or not, to control “records.” Here are a few interpretations I noticed – (a) Directly Against, (b) “For and Against” at the same time, © “For and Against” at different time.

(a) What’s a Record?

In order to understand what a record is, we must begin with another standard in the family, ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. In this standard, we find the definition of a record. Simply put, a record is a document, and can be used as an input from one process to another, but in contrast to documents that are purely informative, a record is generated to state results achieved or to provide evidence of activities performed.

It is because of this difference that different rules apply to the control of records than for the control of documents (clause 4.2.3). Records are not issued, revised or tracked by revision. While a record could be amended to reflect new or updated information, the original record would not be affected.

http://masquality.co...rds_061508.html

(b) 4.2.1.1. Procedures are documents that provide direction on how to perform specific task. A procedure is a controlled document

4.2.1.2. Forms are documents used to record information. The format of a form is controlled but not the information used to complete the form.

4.2.1.3. Reference Charts are documents used where the information contained in the document is controlled but not necessarily the format of the information

http://www.p2pays.org/ref/38/37939.pdf

© Document vs. Record
It's sometimes possible for an item to exhibit characteristics of both a document and a record. Work orders, sales orders and purchase orders, to name a few, can function as both historical records and live documents. In these cases, the item is treated as a document until its real-time informational value has been exhausted. At that point, it's treated as a record.

http://www.dmscoinc....i...3&Itemid=43

One suspects that the ISO Gnomes are invisibly chuckling behind their closed doors.

It does seem easier to use the nice electronic “any printed documents are uncontrolled” approach but not so practical on many production floors. Personally I control form formats but have also found the [“minor” textual, etc amendments do not require an official revision update] option a very useful tool.

Regards / Charles.C

Ps with respect to yr original question, maybe you hv half of, each of, 4.2.1.2 and 4.2.1.3 above

Good efforts Charles!

You did a lot to highlight new points for thinking.

I agree with you that many areas are left unexplained in ISO standards and become doubtful for many users.

Probably, as a general practice, ISO explained or will explain the same in their guidelines or next revision of standards. Till we can not do except .

Do some body have ISO/TS 22004? Probably it contains the explanation why ISO 22K STATES that verified Flow Diagram shall be maintained as a record? (and NOT STATES that approved documented procedure shall be maintained as a record ).

I suggest Simon to make a list of such issues (unsolved or partially solved queries on the forum related to ISO standards) and send them all to ISO's relevant technical committees. At least this is a great contribution from our side to make standards easier for all users.

Regards:
M.Zeeshan Zaki.

Dear all!

538 views and only a few replies .

I request all experts in the field of documentation and ISO standards to add their comments.

Regards:

Once the process flow diagram is prepared, FSMS team should go physically and verify each step shown in the flow diagram. Then this flowdiagram should be signed with date and same should be maintained as record for proof on onsite verification. At the other hand once the verification is over a controlled copy should be maintained and approved by senior authority.

If process step do not match with flow diagram, it should be modified accordingly and same exercise should be repeated and records need to be maintained.

Record of verification is needed if there is any change in the process step, equipment, method. Flow diagram should be modified accordingly and again on site verification should be done by FSMS team.

Regards

Dear Zeeshan,

Do some body have ISO/TS 22004? Probably it contains the explanation why ISO 22K STATES that verified Flow Diagram shall be maintained as a record? (and NOT STATES that approved documented procedure shall be maintained as a record

As far as I can see, it stays well away from this classically, well-proven, awkward topic. On the other hand, it introduces (or re-iterates) a few additional equally debatable ideas, eg -

"Where a control measure cannot be validated, it cannot be included within a HACCP plan or in operational PRPs, but it can be applied within PRPs" (underline from me).

A likely candidate for the upcoming 22005 revision IMO.

Rgds / Charles.C

added - one can similarly question the main standard on a related issue -

eg verification planning 7.8 has this -

(a) the PRPs are implemented

and

© the oprps and the elements within the HACCP plan are implemented and effective.

Does this mean that the prps are not required to be effective ? Obviously not but ???