QMS Documentation Management

About ASQ's Ask the Standards Expert program and blog

Q: I was wondering if ASQ has any good information on managing QMS documentation.  My company is working right now on finding a solution for a better way to manage QMS documentation.  We have previewed some QMS document management software but think we can do all of the programming in house with Microsoft SharePoint. If you have any suggestions I would love to hear them.

A: Thank you for contacting ASQ.  According to The Quality Improvement Glossary by Donald L. Siebels, a quality management system is “a formalized system that documents the structure, responsibilities, and procedures required to achieve effective customer satisfaction levels”.

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

Cost of Quality (COQ)

Manufacturing, inspection, exclusions

Q: Hello, I am having trouble locating basic summary information about the “cost of quality” for various industries.  In brief: what is the cost of NOT having good quality in specific industries, such as automotive.  Put another way, what is it worth to a “typical” company or industry to enact good or better quality practices?   I realize this is an abstract question with many underlying variables, and looked at some old (1999) work on this, but am seeking any summary information you might know of.  Thanks so much.

A: Thank you for contacting ASQ and the Quality Information Center.  I received your request for some information regarding cost of quality.

Donald L. Siebels, in his book The Quality Improvement Glossary, defines quality costs as “a measure of the cost specifically associated with the achievement or nonachievement of product or service quality, including all product or service requirements established by the company and its contracts with customers and society.  More specifically, quality costs are the total of the cost incurred by (1) investing in the prevention of nonconformances to requirements; (2) appraising a product or service for conformance to requirements; and (3) failure to meet requirements.  These can then be categorized as prevention, appraisal, and failure”.  Additionally, Siebels defines the cost of poor quality (COPQ) as “costs associated with providing poor quality products or services”.

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

Voice of the Customer (VOC)

About ASQ's Ask the Standards Expert program and blog

Q: I’m looking for general information on “Voice of the Customer”.  Specifically, I’m putting a slide show presentation together and was interested in any guidance that you could offer, thanks.

A: Thank you for contacting ASQ.  I received your request for information regarding voice of the customer.  Voice of the customer can be defined as “expressed requirements and expectations of customers relative to products or services, as documented and disseminated to the members of the providing organization” (from The Quality Improvement Glossary by Donald L. Siebels).

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

Design of Experiments (DOE)

ISO 13485, medical devices, medical device manufacturing, design of experiments

Q: I am looking for research articles or review papers on Design of experiments (DOE) specially focused on Response surface methods, Split Plot designs, MANOVA, and Repeated measures designs and analysis.  Any help to locate these articles will be greatly appreciated.

A: Thank you for contacting ASQ. I received your request for information on the topic of Design of Experiments (DOE).  Design of Experiments is defined as “a method for carrying out carefully planned experiments on a process.  By using a prescribed plan for the set of experiments and analyzing the data according to certain procedures, a great deal of information can be obtained from a minimum number of experiments” (from The Quality Toolbox, 2nd Ed. by Nancy R. Tague, Quality Press, 2005).

Use the link below to review information on your topics of interest.