Month: December 2016

Transition to ISO 9001: 2015

Reporting, best practices, non-compliance reporting, analysis

Question

We are in the process of reviewing our policies and procedures to be compliant with the ISO 9001: 2015 standard. When converting from ISO 9001: 2008 to ISO 9001: 2015, how should the version control be handled? Should we start at 0 again or move on to the next number?

Answer

I would recommend that the site does not re-number the revisions to zero.  The revision number should be used only for new procedures.

John G. Surak, PhD
Surak and Associates
Clemson, SC
A member of Stratecon International Consultants
http://www.stratecon-intl.com/jsurak.html

For more on this topic, please visit ASQ’s website.

Cleanrooms, Classes, and Control Charts

Sterile, Lab, Clean Room, Requirements, Standard

Question

My question has to do with cleanroom monitoring, specifically particle counts. Using ISO 14644-1: 1999, (we are still transitioning to the new standard), we have 27 test sites in our cleanroom. Our Particle Counter takes 10 readings per minute and averages those readings into one value. This is the number we record at each of the 27 test sites. Since an ISO Class 8 Cleanroom can have no more than 3,520,000 particles greater than 0.5 micron in size per cubic meter, for the room, do you add all 27 results and compare to the acceptance criteria? Do you average all 27 results and compare to the acceptance criteria? or as long as each individual result is below the acceptance criteria we are in compliance? what makes me think you add all results together is that the acceptance criteria states: ISO Class 8 Cleanroom can have no more than 3,520,000 particles greater than 0.5 micron in size per cubic meter, for the room. Your input would be greatly appreciated!

Answer

The way for analyzing these data is very straightforward. Considering you have continuous data, the most appropriate way for accomplishing this is by using a control chart. Use the 27 readings for constructing the averages needed for a control chart. Identify control limits and respond to special cause variation only. You will know that you are in compliance as long as your control charts remain under control. If you ever find any points out of control, you may want to quarantine the product processed during that time and conduct the appropriate corrective actions. As your regular housekeeping, keep the cleanroom certification current. The same for the particle counter system calibration.

If you are new to control charts, the easiest/simplest reference I have ever found is Understanding Variation – The Key to Managing Chaos by Donald J. Wheeler.

Based on your data performance, you may also be able to identify areas within your cleanroom that perform better than class 8 (7 or better). Knowing where those areas are may be handy.

Regards,

Aura Stewart

For more on this topic, please visit ASQ’s website.

Customer Satisfaction

Gage R&R, Torque Wrence

Question

The question is about 9.3.2.1 in IATF 16949. It said the input to management review shall include (f) customer satisfaction. Because that clause is supplemental to ISO 9001, 9.3.2, where C (1) customer satisfaction and feedback from relevant interested parties is inclusive, why does it repeat here? I asked to see 9.2.1 in ISO 9001 but I didn’t see any specific difference between them.

Answer

That’s a very good question, and you’re right that it’s a subtle difference.  It seems that the reference to clause 9.1.2 in the 16949 clause 9.3.2.1 makes it very specific and deliberate that the customer satisfaction being referred to must include “perception” (9.1.2) and that the customer satisfaction in management review will be derived from how “the organization shall determine the methods for obtaining, monitoring and reviewing this information”  (9.1.2).   I hope you find this clarification helpful.

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

For more on this topic, please visit ASQ’s website.