Changing Text Procedures into Flowcharts

[Stijloor]

I agree with Jane and the text quoted from the standard. I would like to share an NCR that I am currently responding to for:

4.2.4 - As required by the international standards ISO 9001:2008 and ISO 13485:2003, a documented procedure for Control of Records is not found in evidence.

The evidence provided during the audit was a flowchart titled "Quality Records", but it did not specifically say "procedure".

Since 2005, we have used this flowchart for our procedure and it is listed in the "Process #" Column an our ISO requirement matrix also provided during the audit. We also have additional records that show we are in control of this process.

Right now my corrective action plan is specify "Procedure" on all of the flowcharts. I know it will clarify things, but my opinion is this should have been an observation.

Comments?
Thanks,

If your flowchart addresses the requirements spelled out in Clause 4.2.4, then the Auditor is mistaken. You decide in what form the "procedure" is produced. It can be a flowchart, work instruction, procedure, a video recording, a power point presentation, whatever....

Stijloor.

 

[JaneB]

4.2.4 - As required by the international standards ISO 9001:2008 and ISO 13485:2003, a documented procedure for Control of Records is not found in evidence.

The evidence provided during the audit was a flowchart titled "Quality Records", but it did not specifically say "procedure".

What??

The auditor is splitting hairs, being nitpicky - and is also wrong.

To insist that a flowchart "did not specifically say procedure" is the kind of hairsplitting garbage that gives so-called 'quality auditors' a bad name (and rightly so). If you present something and explain 'this is our procedure' and show the kind of evidence that you did, that should be adequate.

No decent, even reasonably competent auditor would ever raise that as an NC, and nor should they. One of the things they must be is willing to consider alternative points of view and alternative ways of doing things, not dictating how they should think a procedure 'should' look or 'should' be titled!

I'd push back/protest/complain about it - take it up with the auditor's manager "back at the office". The auditor is attempting to foist his own misguided opinion onto you.

As Jan says, a procedure can be in whatever format you decide that works for you.

PS, while you're about it, consider asking for a better auditor to be sent to you next time. This one needs some recalibration, to say the least.

 

[QSMLauren]

Thanks for the responses. I totally agree. I did end up having to call the Registrar during the audit for a different potential NCR that had no valid support in the standard (another auditor opinion). I decided not worth my time on this one - The registrar can just read the nonsense themselves on the NCR during their technical review.

It is disappointing that his time and now my time was not being spent on things that matter.

 

[Jim Wynne]

I agree with Jane and the text quoted from the standard. I would like to share an NCR that I am currently responding to for:

4.2.4 - As required by the international standards ISO 9001:2008 and ISO 13485:2003, a documented procedure for Control of Records is not found in evidence.

The evidence provided during the audit was a flowchart titled "Quality Records", but it did not specifically say "procedure".

Since 2005, we have used this flowchart for our procedure and it is listed in the "Process #" Column an our ISO requirement matrix also provided during the audit. We also have additional records that show we are in control of this process.

Right now my corrective action plan is specify "Procedure" on all of the flowcharts. I know it will clarify things, but my opinion is this should have been an observation.

Comments?
Thanks,

4.2.4 of ISO 9001:2008 says, in part, "The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records."

If your flowchart defines the requisite controls, your auditor is wrong.

 

[db]

The evidence provided during the audit was a flowchart titled "Quality Records", but it did not specifically say "procedure".

What it is called is meaningless as long as the folks understand what it is. The real questions is: are all of the controls (requirements) found in the standard covered? ISO 9001 and ISO 13485 both have things which must be addressed in the procedure. If all of those are covered in a flowchart, or a pictogram, or a coloring book, they are all covered.

 

[JaneB]

It is disappointing that his time and now my time was not being spent on things that matter.

Yes indeed. Perhaps worth considering whether another certifier could provide better auditors? Because once... OK. But twice??

 

[Chris_Anderson]

Just to piggyback on what Jane has said, I wonder if all of the text procedures will translate conveniently to a flowchart format.

As an example, (and one I'm familiar with) Calibration is often something that is rather involved and while certainly a very simple outline could be knocked off in a flowchart form, there would still be need for fairly specific instructions etc downstream.
Just something to think about.

Personally, rather than trying to convince management to change hundreds of documents, I would look at making the changes as the need for revisions come up. Or, if there are "down times" in your industry, you could use this as kind of "filler work"



Peace
James

The job of a process map is to describe a process. Procedures are not what is required, even for calibration. Since calibration requires a record then you can put calibration instructions on the record or include the information in your training. If you must then create a work instruction, job aid, or procedure but realize that there are others methods besides always using a procedure. What is important in calibration is that the schedule is followed, the devices get calibrated to a reference, and you have a containment/investigation process when they device is found to be out of calibration. If devices are not getting calibrated correctly then you have a training problem and not a procedure problem.

 

[Chris_Anderson]

Re: text procedures into flowchart

Hi
thanks for your kind reply

OK, From your experience, How can I convince my management for such action ( transform hundreds papers of text procedures to flowcharts)? Are there any famous organization do the same?

If you need to produce a lot of process maps then consider having each process owner produce their own process map. It is their process right? Then they should take the next step and produce data about their process. In purchasing they should be looking at how many purchase orders they write, how many are complete and accurate the first time, how many are filled correctly, and looking at supplier performance.

 

[Chris_Anderson]

Re: text procedures into flowchart

Dawelah,
Good stuff.

You can call it (identify it as) anything you like, whether that be purchasing flowchart, process or procedure.

Is it' acceptable' ?
Depends what you mean. Acceptable to whom?

1. If it's acceptable and useful in your organisation, then that's great - and the most important thing.

2. If you mean 'will an auditor accept it', the answer is yes. No auditor has the right to dictate how or what format documentation is in! #1 is always more important than #2.

Improvement suggestion only - I'd consider trying to keep the flow of the purchasing process itself as the most important thing, and downplay the 'supplier evaluation/feedback' bit - treat any reference to it as you did initially with the 'Approved Supplier?' branch.
When you refer to it after goods received, it tends to detract from the logical flow a bit. (Unless you mean that it really does take place immediately and in every single case.)


PS, I'm not quite sure what reference you are quoting re. 'clause 4.2.1' - can you clarify?

I would not downplay the supplier evaluation bit because it is a required element of ISO 7.4 and requires a supplier evaluation record. In fact, this is one of the most important parts of purchasing, which is to define how you are evaluating suppliers. Are you looking at purchase order performance by supplier? How good are your suppliers at on time delivery, product quality, or response time to quotes or requests for information. One way to do this is to track each purchase order transaction.

I would suggest you add more of the supplier performance information above to the purchasing process to improve the ISO conformance for clause 7.4 and not downplay the evaluation.