January 2014 -

ISO 9001:2008 Quality Manager Titles

Workplace safety, OHSAS 18001, work environments

Question:

Is it a requirement that a person in an ISO 9001 registered organization who is responsible for fulfilling the duties and requirements of the management representative hold the title of Management Representative, i.e., is it a noncompliance that such person holds a different title, e.g., specifically, Quality Representative?

Response:

I have seen this question come up at other times. Basically, I refer to how we need to understand the word “shall”. “Shall”, when used in the ISO standards, indicates a requirement.

Therefore, when clause 5.5.2 in ISO 9001:2008 says, “Top management shall appoint a member of the organization’s management . . . .”, then it is a requirement. There are good reasons for this. For one, the Management Representative must have the authority to perform those duties necessary for the successful implementation and continuation of a quality management system. Generally, a person in management knows the company’s business and has a working relationship with all the departments.
It is sometimes a practice to give a person a management title but limit their authority to that which is related to the QMS.

I hope this is helpful to you and thank you for sending your question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Follow Up Question:

Hello,

I appreciate and fully understand your answer, however, I probably did not pose my question adequately. The responsibilities of the MR is clearly assigned to a member of management, and, in fact is the QM, but does not use the title “Management Representative”, but instead uses “Quality Representative”. So, in affect, there is no “MR” in the company. Is this an issue?

Thanks.

Response:

If you wanted to add verbiage to your Quality Manual or one of your documented procedures (i.e. Management Responsibility) which clarifies this you could. However, you do not have to.

The standard says your MR shall be a member of management. The standard does not direct you to make this an official “title”. It just needs to be clear that someone from management fulfills all the responsibilities of the MR. Those responsibilities can be in addition to that individual’s primary function.

It sounds like you are doing OK.

Bud Salsbury
ASQ Senior Member, CQT, CQI

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

Recommended AQLs for Packaging Material in the Pharmaceutical Industry

Pharmaceutical sampling

Question:

Are there recommended AQLs (critical, major and minor defects) for packaging material (primary and secondary) for the Pharmaceutical Industry?
Thank you

Response:

Though there are no recommended AQLs (or LTPD) for packaging materials, some industry standards have begun to surface. The following table is a guideline that I have seen used successfully for a risk based approach to sampling. Based on the severity and criticality of the packaging materials, these guidelines can be adjusted up to down per your risk management process. Utilizing a c=0 sampling plan based on the binomial distribution, the sample size can be calculated using the following formula.

	Primary			Secondary
	Confidence (%)	Reliability (%)	Sample Size	Confidence (%)	Reliability (%)		Sample Size
Critical	99.5	99	527	99	97	151
Major	99	97	151	97	95	68
Minor	97	95	68	95	90	28

I hope this assists you.

Steven Walfish
Secretary, U.S. TAG to ISO/TC 69
ASQ, CQE
Principal Statistician, BD
http://statisticaloutsourcingservices.com

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

ISO 9001:2008 Evidence of Conformity

Checklist, Conformity, Go/No Go

Question
ISO 9001:2008 states in 8.2.4 Monitoring and measurement of product: “Evidence of conformity with the acceptance criteria shall be maintained.”

When our plan identifies periodic inspections, variable or attribute, are performed, how can we show evidence without recording the specific results obtained during the inspection?

Answer
Thanks for contacting ASQ’s Ask the Experts Program. With regard to your question, please note that the primary intent of ISO 9001:2008, clause 8.2.4 is to ensure that the organization has established acceptance criteria and that a record is maintained to verify that product requirements have been met. This verification can be performed by documenting the results of actual measurements taken onto a spreadsheet, shop router, traveler, quality plan or other suitable means.

Another approach could be the use of a “Go” “No Go” gauge and a checklist to record inspection measurement results as pass or fail. There are many different ways of maintaining a record of inspection results. However, regardless of how measurements are taken, their results must be documented to provide evidence of conformance. Unless a record is maintained, there is no evidence that the inspection ever happened or that the product meets defined requirements.

I hope this helps.

Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
www.astontechconsult.com