Supplier Questionnaire about statistical process controls and where we use them

[kevinmurphy]

Our medical client is facing their anual ISO external audit and has forwarded a questionnaire. We are currently using ANSI/ASQC sampling plans/charts. There is an additional related question on what statistical process controls are used and where?

Can anyone help enlighten me as to what are the differences are and some examples of statistical process controls they may be reffering too?

There is also a calibration question - Do we have a documented calibration program (Not yet) and are they NIST traceable?

Any insight here?

 

[Craig H.]

Kevin, I don't quite know how to put this, but frankly I would be surprised if there would be any response if you wrote "we count product on our fingers and toes". I am on record here about those confounded surveys.

That said, the question is fairly wide open, as the word "statistics" is often widely interpreted. What do you measure and report internally? What do you use to control your process(es)? Ideally you would have IMR or Xbar&R charts for key metrics. If so, say so.

As far as calibration, what do you use to measure? Is it calibrated (internally or by a contractor)? If it is calibrated internally, whatever you use to calibrate should be checked at a defined time interval against something that has been compared to (to something that has been compared to, to something that has been compared to, etc.) a nationally or internationally recognized standard. This is often, but not always NIST in the U.S. For calibration by a contractor, there should be paperwork that indicates what standard they are using and what tracability (to NIST, for instance) it has.

Hope this helps!

 

[kevinmurphy]

supplier questionnaire

You are probably right about counting on fingers and toes. This is another paper trail/documentation item to prove they investigate their suppliers are compliant and probably are never even read - just filed and dated for record requirements.

None the less my research into our calibration records indicate we are 2 years behind. I wonder how we have gotten by the last couple of surveys before they hired me (1st QA Mgr)? I question if we have ever sent them copies as they have requested and the client just never even checked what we have sent.

I have to have the Pres. set up a schedule for calibration tests before the client starts to miss their documentation from us.

A concerning issue for me has been tha our production supervisor walked off the job and I have been filling in on some additional supervisor responsibilities since then. Now our senior machine operator has complained "I am not her boss and she does not have to listen to me." Management has decided the foreman will assign her daily duties and I will supervise all quality product and process areas. Thus I will still have to inspect her work, etc.

This is a sticky situation for a small company that all ready views QA as a costly feature they are unsure that they really even want - other than to fill out forms (CAPA, MRR, questionnaires, etc.) Is this something usual for a small compnay to question the value of QC/QA? We all are aware of the long term benefits of becoming ISO certified (additional contracts) but small companies see to ony look @ short term costs and benefits.

My main concern is after I have taken care of the ISO paperwork needed for clients going through their annual end of year audits and CAPAs for tem my dept/job may not be viewed as cost efective/viable until next ears fourth quarter.

Any recommendations on how to teach management the plus side of QA and not just view the costs/down side? Or just get my resume updated?