Analysis of Data vs. Monitoring and Measuring - ISO13485 requirements

R

Randy-BCEC

#1
I am deep in the throws of writing procedures based on our currently undocumented processes. Maybe I am just at the point of procedure paralysis, but I am stuck regardless.

8.4 talks in terms of procedures to determine, collect, and analyze appropriate data

8.2.3 says that we shall apply suitable methods for monitoring and measuring the quality management system processes

8.2.4 says that we shall monitor and measure the characteristics of the product and evidence of conformity with acceptance criteria shall be maintained

So ... I am thinking that a procedure for 8.2.3 and 8.2.4 would focus on the measurement piece and how we collect data. 8.4 then would be more along the lines of what we do with the data (SPC, statistical sampling, root cause analysis, etc...)

Am I thinking correctly? Does anyone have any examples of the two procedure or at least how other companies approach these sections?
 
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R

Randy-BCEC

#3
Re: ISO13485 - Analysis of Data vs. Monitoring and Measuring

Thanks Doug. I guess maybe I should invest the $90 or so in 14969.
 
R

Randy-BCEC

#5
Re: ISO13485 - Analysis of Data vs. Monitoring and Measuring

I just downloaded it. At first glance, it looks like it will help quite a bit.

Thanks for the suggestion.
 
R

Randy-BCEC

#6
Re: ISO13485 - Analysis of Data vs. Monitoring and Measuring

ISO14969 isn't real clear on measuring and monitoring vs. analysis of data. Maybe I am just not seeing it because the terminology is little different.

Does anyone have examples of what they have done to address 8.2.3, 8.2.4, and 8.4?
 

yodon

Staff member
Super Moderator
#7
Re: ISO13485 - Analysis of Data vs. Monitoring and Measuring

What I've seen is more handwaving than anything. You can't really say HOW you're going to collect, measure, and analyze data until you know what the data is. So the procedrues I've seen basically say we'll use proper techniques for the data we do gather (and that we'll gather proper data... properly :). I expect that's why 14969 isn't more help (in these areas).

When you get to the point of collecting and analyzing data, you can then demonstrate you're using techiniques that are appropriate.
 

Peter Selvey

Staff member
Super Moderator
#9
It looks like there is a historical background here that may be worth considering. The old ISO 13485:1996 did not have the process approach, but it did have a clause (4.20) on statistical analysis of data.

It appears that 4.20 got transferred across to 8.4 (analysis of data), which is really focused on tangible matters such as PCB failure rates, percentage of rework, number of customer complaints, supplier delivery delays, turnover of replacement parts and so on. The critical point here is that a procedure should define who is responsible to decide what data gets collected and analyzed, and how this can feed through to preventative action if needed, and finally that records are considered "quality records". In my experience as an auditor, it seems just about every section runs their own excel spreadsheet with colourful graphs analyzing something or other. This meets ISO 9001 but this alone does not meet ISO 13485 because there is often (a) no procedure saying this should be done (b) the excel files are not retained as quality records (c) decisions to take action are not recorded, e.g. by interfacing with the CAPA system. In the real world, everyone loves to make these excel sheets, but enthusiasm often wains on the action side, things get lost/forgotten in the informal approach.

Separate to this, the process approach meant that process monitoring was needed, so a new Clause 8.2.3, process monitoring, was added. This specifically covers processes of the quality system. We are all still trying to get a handle on this. I can think of good examples, for example, statistics on the CAPA system (number opened, number closed, number overdue) might show if the system is working well or needs some tweaks (like redefining what goes into CAPA to avoid under/overloading the system, a common problem). But other processes are not easy handled by numerical analysis. Just thinking out loud: 8.2.3 might simply be met by having persons responsible, once per year, reviewing procedures and implementation and making a statement or short report on whether the quality system process (management review, internal audit, design control etc) are functioning as expected.

Clause 8.2.4 (monitoring of the product), by the way, is not directly related to 8.2.3 or 8.4. This clause relates to production tests, such as verifying the accuracy of a thermometer. However, data from this process (e.g. failure rates, or margin to limits) should be used as an input for Clause 8.4.

Hope this helps - Peter
 
D

DrM2u

#10
So ... I am thinking that a procedure for 8.2.3 and 8.2.4 would focus on the measurement piece and how we collect data. 8.4 then would be more along the lines of what we do with the data (SPC, statistical sampling, root cause analysis, etc...)

Am I thinking correctly? Does anyone have any examples of the two procedure or at least how other companies approach these sections?
:read: First let's clarify the requirements. ISO 13485:2003 DOES NOT require a documented procedure for 8.2.3 or 8.2.4 clauses, so it is up to your organization to decide if you need aprocedure. My guess is that you already identify what product data are collecting in your control plans and what process data are collecting in your performance metrics. So, do you still need a procedure?!? Your call. Anyway, the intent if 8.2.3 and 8.2.4 is to require the collection of data related to the product and processes.

As far as 8.4 goes, ISO 13485:2003 DOES require a documented procedure. The intent of this clause is to analyze and use the data collected as part of 8.2.3 & 8.2.4 to identify opportunities. After all, data that is collected and not used is nothing but wasted efforts, money, time, etc. The procedure does not have to be anything special or extremely detailed. It can simply state what data sources you use (customers, product, process and suppliers), that you analyze it using suitable methods (i.e. Pareto charts, hystograms, trend plots, SPC, etc), and that you are doing something with the results (i.e. management review, improvement actions, planning, etc). Honestly, I do not know why the standard requires a documented procedure for data analysis but the requirement is there and needs to be addressed.:confused:

I am attaching a procedure for data analysis that reflects my response and hope it helps answer your question. That's all I have for :2cents:.
 

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