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”.  The ASQ Knowledge Center has over 100 resources on the topic of quality management systems and documentation.

  • One of ASQ’s resources that you may find particularly helpful is a recent case study on a company that used a wiki to document its QMS:

Geometrica Builds ISO 9001 QMS on Wiki

For more information, please see the references listed at the end of the case study, including the following:

“After Geometrica attained ISO 9001:2008 certification in 2009, it wrote—and improved—this case study on a wiki. Visit Geometrica’s “living” case study

  • A little older resource, but this eBook might be helpful:

The Practical Guide to People-Friendly Documentation

  • You may also want to take a look at this October 2010 Quality Progress article:

Get Your Ducks in a Row: A step-by-step guide to implementing an ISO 9001 quality management system” (See section on “Gathering, managing information”)

 (See section 4 on Documentation)

I hope that this information is helpful.  Please feel free to contact me with any questions or if you need additional assistance.

Best regards,

ASQ Research Librarian
Milwaukee, WI

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”.

I have searched the ASQ Knowledge Center and the ASQ website and have found some resources on COQ that I think might also help to answer your question:

Learn About Quality: COQ webpage

ASQ has a COQ webpage that provides the basics on cost of quality that you might be interested in taking a look at.  The COQ page is part of the ASQ Learn About Quality webpages.

Articles/Case Studies:

You may also want to check out more Quality Progress articles under the heading of “Economic Case for Quality

Book:

The Executive Guide to Understanding and Implementing Quality Cost Programs (2008)

Video:

The Cost of Poor Quality“, from ASQ’s Audit Division

I hope that this information is helpful.  If you would like to search on your own for ASQ resources, you can do so in the ASQ Knowledge Center.  If you have any questions, please feel free to contact me.

Best regards,

ASQ Research Librarian
Milwaukee, WI

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 and the Quality Information Center.  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).

ASQ has over 100 resources on voice of the customer in the ASQ Knowledge Center.  I have listed some suggested articles and other resources below:

Articles/Case Studies:

High Priority: Voice of the customer analysis can help you build business-to-business relationships“, Quality Progress, Feb. 2010

Translate Know-What Into Know-How“, Quality Progress, Dec. 2003 (open access)

Ways to Evaluate Voice of the Customer Information for Meaningful Improvement“, World Conference on Quality and Improvement, June 2003

Using Qualitative Data to Learn About Customer Needs: Understanding Employer Desires When Designing an MBA Program“, Quality Management Journal, April 2008

Taking the Wheel“, Quality Progress, Feb. 2012

Deliver Great Service By Listening and Adapting“, Quality Progress, March 2007

In It for the Long Haul“, Quality Progress, Feb. 2010

Webcast:

Voice of the Customer Webcast“, August 2010

Voice of the Customer Table Tutorial:

VOCT Tutorial

I hope that this information is helpful.  Please let me know if you have any questions or if you need additional assistance.

Best regards,

ASQ Research Librarian
Milwaukee, WI

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 and the Quality Information Center. I received your request for articles 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).

I searched the ASQ Knowledge Center for articles that focus on the specific areas you mentioned you were interested in.  I pulled some articles from my search results and have listed them below.  I have also included a link to the full search results so that you can take a look at all of the articles I found.

Response Surface Methods articles (Here is the link to the search results I received):

Split Plot Designs: (Full search results)

MANOVA: (Full search results)

Repeated Measures designs and analysis: (Full search results)

I hope that this information is helpful.  Please let me know if you have any questions or if you need additional assistance.

Best regards,

ASQ Research Librarian
Milwaukee, WI