Interpretation of ISO 13485 Clause 8.4 - Analysis of Data

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Roland Cooke

#1
I thought I would share this discussion between two of my auditors, to see if there are other opinions out there in Elsmarland, our internal discussion is ongoing.

8.4 of the standard requires documented procedures for analysis of data.

I have had many clients that do not have one of these and point to management review or the Q manual as fulfilling this requirement. I continue to write this up and each company continues to argue that they do not need a separate documented procedure if they describe the activities in the QM.

Then my question is why does the standard say documented procedure. Is the QM considered a documented procedure or do they need a separate documented procedure. And then if the QM is accepted then why does anyone have any documented procedures if they can all be in the QM.

I am writing this to ask your opinion on this because the [company X] desk study reveals no documented procedure for analysis of data and the management review does not address it.
Response:
8.4 is clear in requiring a documented procedure, however, a company could have very clear definitions of how they determine, collect and analyze the data in another procedure. What is usually lacking when they don't do a specific procedure for 8.4 is the tie-in back to 4.1 (f). The company has to have clear metrics they are using for this data.

What is usually seen in Management Review is a report of the areas and no clear link to demonstrating the "improvement of the effectiveness" of the QMS. My concern is that a company doesn't seem to understand the importance of this analysis rather than just reporting.

Opinions welcomed!
 
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Pazuzu - 2009

#2
Re: Analysis of Data

Assuming this is the ISO9001:2000 standard you are referring to, nowhere in 8.4 does it state that there must be a documented procedure for Analysis of Data.
 

Jim Wynne

Staff member
Admin
#4
Re: Analysis of Data

Damn.



Lucky I posted this in the right forum then. ;)
I'm have no specific expertise in the medical products area, but it seems to me that if you read "documented procedure" as "documented process" and if "the organization" has has a documented process for analysis of data, it shouldn't matter what container the documentation is in.
 
R

Roland Cooke

#5
Re: Analysis of Data

You make a valid point Jim, not sure if it fully applies here though.

The text of ISO13485:2003 8.4 is as follows:

The organisation shall establish documented procedures to determine, collect and and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate if improvement of the effectiveness of the quality management system can be made.

This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to

a) feedback

b) conformity to product requirements

c) characteristics and trends of processes including opportunities for preventive action, and

d) suppliers.

Records of the results of the analysis of data shall be maintained (see 4.2.4)
Italics indicate where ISO13485:2003 differs from ISO9001:2000.


Personally what I look for is a strategy for identifying what data needs to be gathered*, work instructions that enable the data to be gathered, work instructions that enable the data to be presented, and work instructions that require the data to be analysed and appropriate action taken as a consequence**.

*i.e. as part of an overall (product) risk management programme
**i.e. as part of an overall risk management programme and QMS effectiveness programme


To my mind the above cannot all easily be catered for by the MR or QM (but I would be wary of saying that it is impossible).
 

Jim Wynne

Staff member
Admin
#6
Re: Analysis of Data

You make a valid point Jim, not sure if it fully applies here though.

The text of ISO13485:2003 8.4 is as follows:



Italics indicate where ISO13485:2003 differs from ISO9001:2000.


Personally what I look for is a strategy for identifying what data needs to be gathered*, work instructions that enable the data to be gathered, work instructions that enable the data to be presented, and work instructions that require the data to be analysed and appropriate action taken as a consequence**.

*i.e. as part of an overall (product) risk management programme
**i.e. as part of an overall risk management programme and QMS effectiveness programme


To my mind the above cannot all easily be catered for by the MR or QM (but I would be wary of saying that it is impossible).
Then your problem isn't with the location of the documentation, per se, but with its extent, which is a different issue. While I agree that the QM isn't a good place for that sort of thing, if all of the requirements are met, it still doesn't matter much where they reside.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Re: Analysis of Data

I checked ISO/TR 14969 - Guidance on the application of ISO 13485.
As it relates to the documented procedure issue, it states:
[FONT=Helvetica, sans-serif]4.2.1.1 [/FONT][FONT=Helvetica, sans-serif]Documented quality management system procedures are required for applicable requirements of ISO 13485 and should be consistent with the organization’s quality policy. It is important to recognize that the structure and level of detail required in these procedures should be tailored to the needs of the organization, which in turn are dependent on the methods used and the skills and qualifications of the organization’s personnel performing the activities in question (see also 6.2.2). Procedures or instructions may be presented in text, graphic or audio-visual form. Frequently a simple set of pictures can convey the requirements more accurately than a lengthy detailed description. [/FONT]

[FONT=Helvetica, sans-serif]4.2.1.2 [/FONT][FONT=Helvetica, sans-serif]Documented procedures, including work instructions and flowcharts, should be stated simply, unambiguously and understandably, and should indicate methods to be used and criteria to be satisfied. These procedures typically define activities and describe [/FONT]
  • [FONT=Helvetica, sans-serif]what is to be done, and by whom, [/FONT]
  • [FONT=Helvetica, sans-serif]when, where and how it is to be done, [/FONT]
  • [FONT=Helvetica, sans-serif]what materials, equipment and documents are to be used, how an activity is to be monitored and measured, and [/FONT]
  • [FONT=Helvetica, sans-serif]what records are required. [/FONT]
As it relates to 8.4 and expectations of how the data should be used:
[FONT=Helvetica, sans-serif]Data should be collected and analysed in order to verify the ongoing suitability and effectiveness of the quality management system, and to determine if there are any trends or patterns that require attention. Negative trends should be considered for improvement. The results of the analysis of data should be considered for [/FONT]
[FONT=Helvetica, sans-serif]input to management reviews and risk management activities. Analysis of data can help to determine the root cause of existing or potential problems, and thereby to guide decisions about the corrective and preventive actions needed for improvement. [/FONT]
[FONT=Helvetica, sans-serif]For an evaluation of the effectiveness of the quality management system, data and information from relevant parts of the organization should be integrated and analysed. The results of this analysis can be used by the organization to determine [/FONT][FONT=Helvetica, sans-serif]trends in product conformance, the extent to which customer requirements are being met, process effectiveness, supplier performance, and success of performance improvement objectives. [/FONT]
So, the obvious still apply: A documented procedure is required. The format of the procedure is up to the organization, but the data must be analyzed and acted upon.
 
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R

Roland Cooke

#8
Re: Analysis of Data

Then your problem isn't with the location of the documentation, per se, but with its extent, which is a different issue. While I agree that the QM isn't a good place for that sort of thing, if all of the requirements are met, it still doesn't matter much where they reside.
To which the routine answer would be, "Why bother with having any procedures?"

So if I state within my QM that

During the Management Review we will determine, collect and and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate if improvement of the effectiveness of the quality management system can be made.
and I have a couple of procedures for complaint handling/analysis, do I actually need anything else?


That said, I do know where you are coming from, and I have indeed seen some very good QM/procedure hybrids on rare occasions.

However in the real world, I would typically back my auditors in challenging anything as limited as that (not least because it isn't addressing risk management properly).
 
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Benjamin28

#9
Re: Analysis of Data

I agree that placement of the procedure in documents such as the QM and varying other procedures is a poor way of satisfying this requirement. But, if I were the auditor on this I would base my write up on what they actually do. If they can show evidence that they are indeed analysing the necessary data I would be content that the way they've set up their procedure, although disorganized seemingly, works for them. If they scramble, or have difficulty displaying conformance to the procedure, then yes I'd write it up. Otherwise I might put it down as a suggestion to make the procedure seperate from other documents for the sake of better organization.
 
R

Roland Cooke

#10
Re: Analysis of Data

I agree that placement of the procedure in documents such as the QM and varying other procedures is a poor way of satisfying this requirement. But, if I were the auditor on this I would base my write up on what they actually do. If they can show evidence that they are indeed analysing the necessary data I would be content that the way they've set up their procedure, although disorganized seemingly, works for them. If they scramble, or have difficulty displaying conformance to the procedure, then yes I'd write it up. Otherwise I might put it down as a suggestion to make the procedure seperate from other documents for the sake of better organization.
I think we all would agree with that. And of course making hard and fast rules tends to backfire spectacularly.

The problem is that when trying to justify certain approaches to our customers, (who have the full range of experience/knowledge and situations between them), and when trying to achieve consistency between our auditors, that kind of thing often simply isn't robust enough.

It's good for discussion though. :D
 
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