Statistical Process Control (SPC) for Clean Room Environments

V

Vassilis

#1
Dear Covers,

Excuse my question but to many ISO 13485 - ISO 146444 experts may sound as elementary school one....It has been over 2 years since i was employed to a medical device company so i am a little bit rusty concerning ISO 14 644 requirements, but a colleague asked me whether it is an ISO 14 644 requirement to use SPC as a control measure for the airborne particles for any Controlled Environment areas (> class 100,000) ?

I remember that there is a requirement to conduct some kind of statistical evaluation ( i dont remember any details , please share also any of your thoughts on this subject) but i dont think that SPC was a specific requirement.

Any help would be gratefull!!

Vassilis
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Statistical Process Control for Clean Room Environments

My employer isn't registered to ISO 13485 - ISO 14644, but we run clean room under semiconductor industry requirements and SPC for clean room isn't among them.

SPC is generally considered a process for producing the good or service, and is used for determining responses based on their economic validity. So it's definitely okay to make a chart with control limits for decay rates, particulates, temperature/humidity and the like, but I would use a single entry chart and not X-bar and R, or percentages (p), or number in a batch (n).

I would instead establish the control parameters, and response protocols for exceeding X while noting Y trends of ABC data for response or continuous improvement.

Also, feel free to check out the links of related threads at the bottom of this page. It could lead you to some helpful previous discussions.

Anyone else have input? I am not an expert in this area, so please feel free...
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#3
I would agree that an I-MR chart that evaluated the particulate level might detect signals that there was a need for system maintenance. It may help direct the frequency of maintenance, and the idea of using the trend to predict maintenance prior to reaching defect levels is handy. The range may detect sudden increase of particulate, which would also be indicative of a need for maintenance.

I would not expect the data to be normal, I would expect the data to show little variation for a period of time after maintenance, then a more pronounced increase toward the time maintenance is required - depending on the efficiency of the system.

As a capability study, I would simply track this data on a routine basis, plot the data with a 75% of you specification upper limit. When you reach the limit, you will need to determine the appropriate maintenance action, after which the data should retreat to approximately the previous initial value. You may not know if the range data will be of significant value as a signal until you have collected sufficient data.

Don't know until you try..:cool:
 

Ajit Basrur

Staff member
Admin
#4
Great question, Vasillis and its definitely not an elementary school type question :)

I dont think there is any requirement for SPC monitoring for the clean room environment for particles / microbial aerobic counts. I would like to plot a simple line graph to study the trends of the particles / bacterial counts to get a picture on the state of the filtration system.

A trend of high particles / counts in indictive of poor HEPA filter efficiency.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#5
I would like to plot a simple line graph to study the trends of the particles / bacterial counts to get a picture on the state of the filtration system.
This may be all it takes - but it would not be a bad idea to see if an evaluation of the range of an I-MR chart is of predictive value. If not, no problem - go to line graph. After all - no extra charge...:cool:
 
V

Vassilis

#6
I did a little bit of google research and i found an interesting idea of ploting a c-chart of number of particles / m3 ( 0,5 μ and 5μ).Give me your oppinion on that!!!

I would go for a I-MR approach or X-R for a separate part of clean room or both!!!Thats why we thank god statistical analysis software!!!!
 
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