Finding a system

Q: How do you go about establishing a quality information management system?

A: This question is fairly broad because a quality information management system can have many facets—anything from the processes that fall within the quality system to automated or manual systems that deal with customer complaints and handle inspection or analytical data. For the purpose of this discussion, let’s focus on the overall quality system.

Collaborative, web-based solutions are probably one of the most user-friendly applications of technology. The entire quality system can be managed and tracked using this tool, which is the system of record for the quality system.

The solution is structured so any individual can look up a procedure via the quality system. This is possible because the system houses a quality manual that references all the supporting procedures. An individual can approach this in two ways: by looking for a particular procedure that supports a given area of the quality system, or by running a search that scours all areas.

This same system is structured so all of the procedures applicable to a particular job title are available online. If an employee wants to see all of the applicable procedures to the job function they perform, all they need to do is query the system by that job function. The particular area that houses this solution would have training materials linked to the procedures as well. Not only can an employee pull up all their procedures with a single click, they can also easily reference their particular training material.

This system works well and is typically received positively by the entire workforce. Using the automated tool greatly reduces the probability of having an illegal hard copy of the procedure, simply because it doesn’t make sense to print a copy out. Thus, there aren’t any hard copies floating around.

A quality information management system can also refer to a relational database for quality type data. Customer-complaint data, for instance, would fit appropriately in such a system. The data is searchable by customer, complaint type, product type or manufacturing team. It can contain the entire complaint, complaint response, the associated analysis for the root cause and any corrective action taken.

Keith Wagoner
Senior process improvement consultant
Waxhaw, NC

Additional information

  1. "10 Quality Basics," Quality Progress, Vol. 40, No. 6, also available at www.asq.org/quality-progress/2007/06/basic-quality/10-quality-basics.html.
  2. John R. Broomfield, "Develop a Process Based Management System," Quality Progress, Vol. 37, No. 12, also available at www.asq.org/data/subscriptions/qp/2004/1204/qp1204broomfield.html.
  3. Dennis R. Owens, "Craft a Meaningful Quality Policy," Quality Progress, Vol. 38, No. 2, also available at www.asq.org/quality-progress/2005/02/one-good-idea/craft-a-meaningful-quality-policy.html.

Standard diagnosis

Q: We are ISO 9001 certified and run good manufacturing practices (GMP) for a very small portion of our products. Recently, I read about ISO 13485 and am wondering: When and why would we use this standard as opposed to what we are currently doing?

Danielle Hestermann
Senior quality engineer
Greenville, SC

A: ISO 13485 is used specifically for meeting regulatory requirements of the medical device industry. One application is its use by the European Common Market for meeting part of the requirements for a medical device’s CE mark, which certifies that a product has met European Union health, safety and environmental requirements. Ninety percent of the standard is related to ISO 9001, and 10% is additional requirements for the medical device industry.

For example, there are specific requirements for validation of sterilization processes. In a similar vein, there are requirements regarding traceability for implantable medical devices, such as heart valves and pacemakers.

By the nature of your question, I assume your organization is not manufacturing medical devices for Europe. If you are, you would need to have a working knowledge of this standard and comply. It was developed and issued by ISO TC 210, the ISO Technical Committee for Medical Device Quality Management. The secretariat of the technical committee is the Association for the Advancement of Medical Instrumentation.

Joseph Tsiakals
Vice president of quality
Theravance Inc.
San Francisco

Additional information

  1. Joseph Tsiakals, "Will ISO 9001 Still Apply for the Medical Device Industry?" Quality Progress, Vol. 33, No. 9, also available at www.asq.org/quality-progress/2000/09/standards-outlook/will-iso-9001-still-apply-for-the-medical-device-industry.html.

The plot thickens

Q: One of the tools I use often is binomial probability plotting, a technique described by Kaoru Ishikawa in his book Introduction to Quality Control. The technique is powerful, has a wide application area and is extremely visual. Why do so few people know about its existence, much less use it?

A: The binomial probability plot is indeed a powerful statistical tool that can be used for problem solving, process analysis and process improvement in quality and reliability engineering. It also has other applications in marketing, sales and forecasting.

Depending on the objective of the analysis and the background of those who are performing the process analysis and improvement, the selection of tools can vary. Some people prefer to employ analyses that are less statistically oriented to deal with their issues of process improvement.

It is very likely, however, that Six Sigma project champions and Black Belts use tools such as binomial probability plotting for the analysis of problem symptoms. When using binomial probability plotting, binomial papers can be used for the purpose of comparing two machines, two process outcomes or two different sets of data.

Keep in mind that if you’re going to use binomial plotting, you must have a binomial situation that deals, for example, with discovering the differences between two marketing forecasts or the capabilities of two different machines or production lines.

In short, you’re correct that binomial probability plotting probably is not as well publicized as other tools, but it can be a very useful application in the right situation.

Ahmad Elshennawy
University of Central Florida
Department of industrial engineering and management systems
Orlando, FL

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