Monitoring & Measurement of Product for Service Company

L

LandA

#1
We are a service company in the area of cleanroom validation for Pharmaceutical Companies. I'm writing the QM at the moment.
We don't have a "product" per se, but rather our service is our product.
Sec. 8.2.4 requires that we "monitor and measure our product {service}"- I'm a bit stuck as to what we should put in here in our quality manual. I'm thinking review and sign-off by our customer of final report would be release of the "product." Not sure what else we can monitor and measure......customer satisfaction, repeat business has already been included elsewhere......or should I just lump processes and product together in the Quality Manual. Any help please?
 
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#2
We are a service company in the area of cleanroom validation for Pharmaceutical Companies. I'm writing the QM at the moment.
We don't have a "product" per se, but rather our service is our product.
Sec. 8.2.4 requires that we "monitor and measure our product {service}"- I'm a bit stuck as to what we should put in here in our quality manual. I'm thinking review and sign-off by our customer of final report would be release of the "product." Not sure what else we can monitor and measure......customer satisfaction, repeat business has already been included elsewhere......or should I just lump processes and product together in the Quality Manual. Any help please?
Don't you prepare a report of your findings, etc? Isn't that an output from your service? Aren't there some criteria that can be developed for that aspect, as well as others - prompt turnaround of quotes, on time service delivery etc?
 
D

Duke Okes

#3
Every organization has a product. Yours may be "a process that continually maintains a clean room."
 
D

Duke Okes

#4
In answer to your 2nd question, product & process are different.

If your product is the report showing validation results the process is the sequence of activities you go through in order to achieve/check that validation.

Completeness, accuracy & timeliness are three simple examples of metrics on the product. Amount of time it takes to carry out each phase of the validation (e.g., developing validation plan, organizing resources, doing it, reviewing findings) and number of errors/redos within each phase could be process measures. The latter impact the former.
 
L

LandA

#5
Thanks for your reply. The only problem with setting metrics on time for each stage of the process is that each project will vary for timelines etc.
 
J

JaneB

#7
We are a service company in the area of cleanroom validation for Pharmaceutical Companies. I'm writing the QM at the moment.
We don't have a "product" per se, but rather our service is our product.
Sec. 8.2.4 requires that we "monitor and measure our product {service}"- I'm a bit stuck as to what we should put in here in our quality manual. I'm thinking review and sign-off by our customer of final report would be release of the "product." Not sure what else we can monitor and measure......customer satisfaction, repeat business has already been included elsewhere......or should I just lump processes and product together in the Quality Manual. Any help please?
Yes your service is the product. Repeat after me: wherever you read the word 'product' in ISO 9001, you should read it as meaning service and/or product. OK?

But no, you cannot make your customer responsible for monitoring/measuring your service (product)! You have to do that.

Now: what IS your actual service? Assume I know not much at all about "cleanroom validation for Pharmaceutical Companies" (which wouldn' t be far from the truth) and explain it to me simply, say, as you would to a reasonably intelligent 16 year old. What do your customers actually receive from you which presumably they value and pay for?
 
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