Video

Behaviors of a Self-Correcting Organization

Self-correcting organizations are companies in the GXP regulated industry that do not shy away from defects and defect discovery. As Joseph Zec explains in the following interview and recording, there are common, key characteristics of a self-correcting organization that, once adopted and implemented, will lead to global regulatory compliance.


Self-Correcting Organizations: Q&A with Joseph Zec

Q. What is a self-correcting organization?

A self-correcting organization finds and fixes its own problems.

Q. How does a self-correcting organization differ from CAPA?

CAPA is one method an organization can use to become self-correcting.

Q. Who or which group should be the leaders in the becoming a self-correcting organization?

Quality Assurance should lead the charge toward becoming a self-correcting organization because most of the techniques used to become self-correcting come from the QA toolbox. 

Q. Because of the nature of the SDLC, does computer and software validation lend itself to a self-correcting model?

Absolutely. One of the primary goals of a lifecycle approach to validation is to find and correct defects as early as possible before they turn into big headaches. 

Q. How does the concept of a self-correcting organization compare to improvement strategies such as Lean, Six Sigma, or Kaizen?

Lean, Six Sigma, and Kaizen Events are all methodologies that an organization can use to be self-correcting. They all have process improvement as their goal, and process improvement naturally leads to finding and fixing problems with the current process.

Q. How can other validation processes such as cleaning or method apply a self-correcting approach?

By applying a lifecycle approach to validation and by soliciting the involvement and input of the QA organization.

Q. In your experience, are there other non-life science companies that offer good examples of self-correcting organizations?

Automotive, aerospace, finance, and the nuclear power industry are all good examples of where it pays to be self-correcting. Once you leave the world of regulated industries, the return on investment in becoming a self-correcting organization becomes less, although world-class organizations in a variety of industries (Sony for instance) employ self-correcting methodologies.

Q. Is the self-correcting model more applicable to medical device manufacturers or Pharma manufacturers? Why?

A. The concept of a self-correcting organization applies equally to pharma and med devices because they are both regulated and subject to inspection by regulatory bodies. A self-correcting organization will usually get good grades as the result of an inspection.


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