April 2013

For Quality Companies

Correcting and Detecting CAPA Horrors

by: Peter Knauer, Partner Consultant, MasterControl Inc.

The long history of Corrective and Preventive Action (CAPA) requirements within the Food and Drug Administration's (FDA) Quality System Regulations---and specifically 21 CRF 820.100 and ICH Q10---implies that most biomedical companies have evolved a certain level of mature thinking and a good understanding of the fundamental requirements for CAPA systems. This, unfortunately, is not always the case. I am currently spending a lot of time working with client companies in remediation mode; that is, after FDA has found enough flaws to issue a 483 or warning letter. I would like to point out some common CAPA problems that can be proactively rectified to avoid citations in the first place.

First, some data. FDA's 2010 data on warning letters by QMS subsystem shows nearly a third (30%) are still being issued for CAPA problems. Data on 483s shows a similar breakdown (32%). Within the CAPA subsystem, the citation breakdown shows that a full 22% do not even have a CAPA system and 30% that do not properly document the process. The rest of the citations are all are related to the basics of the process, as outlined in 820.100. A well-implemented CAPA process will generally avoid any of the items cited in the chart shown below. Of particular note: 820.100 (a) "establish and maintain procedures," 820.100 (1) "analyzing processes" and 820.100 (b) "documentation" figure prominently. Items 820.100 (1) through (7), the basic CAPA process, are also frequently cited.

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MasterControl Revs Operational Excellence Using Six Sigma

by: Craig Gygi, Executive Vice President Operations, MasterControl Inc.

The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

In a better-late-than-never move, ISO published 13053-1/2:2011, "Quantitative methods in process improvement - Six Sigma - Part 1: DMAIC/Part 2: Tools and techniques." This further confirms Six Sigma and Lean as the standards for global operations.

In good times, any operations approach works well enough. But in today's economy, "good enough" is no longer good enough. Companies striving to be world-class are standardizing on Lean Six Sigma because it has created the process performance improvements and efficiencies required for consistent business success. The track record of Lean Six Sigma has advanced it beyond its predecessors of TQM, theory of constraints, business process reengineering, and the like.

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MasterControl Revs Operational Excellence Using Six Sigma

by: Craig Gygi, Executive Vice President Operations, MasterControl Inc.

The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

In a better-late-than-never move, ISO published 13053-1/2:2011, "Quantitative methods in process improvement - Six Sigma - Part 1: DMAIC/Part 2: Tools and techniques." This further confirms Six Sigma and Lean as the standards for global operations.

In good times, any operations approach works well enough. But in today's economy, "good enough" is no longer good enough. Companies striving to be world-class are standardizing on Lean Six Sigma because it has created the process performance improvements and efficiencies required for consistent business success. The track record of Lean Six Sigma has advanced it beyond its predecessors of TQM, theory of constraints, business process reengineering, and the like.

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