8d Problem Solving Methodology

8d Problem Solving Methodology-10
Frank Adler co-founded Operational Excellence Consulting (OEC) in 2009 to follow his passion for Operational Excellence and to be able to work with individuals and organizations that share this passion.

Frank Adler co-founded Operational Excellence Consulting (OEC) in 2009 to follow his passion for Operational Excellence and to be able to work with individuals and organizations that share this passion.

View more of OEC's materials on Flevy here, including training guides and free downloads.

It was later improved and popularized by the Ford Motor Company in the early ‘90s.

Drug and device manufacturing is one such space where 8D seems like a fit, particularly within corrective and preventive action (CAPA) programs.

But despite its success, the 8D model presents a serious compliance problem under both FDA and global ISO regulations—one that regulators are seizing on as evident by the top-cited inspectional observation within the device space since 2010: of those actions—a serious procedural lapse.

D1 Establish the Team: Establish a small group of people with the process and/or product knowledge, allocated time, authority, and skills in the required technical disciplines to solve the problem and implement corrective actions.

Key Deliverables include: D2 Describe the Problem: Describe the internal or external problem by identifying “what is wrong with what” and detailing the problem in quantifiable terms.

Develop a clear problem statement and problem description.

D3 Develop Interim Containment Actions: Define, verify and implement interim containment action to isolate the effects of the problem from any internal and/or external Customer until permanent corrective (preventive) action are implemented.

Select the best Permanent Corrective Actions to remove the root cause and to address the escape point in the process.

Verify that both decisions will be successful when implemented and not cause any undesirable effects.

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