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Compliance Case Study #3—Manual Processes, Performance, Responsibilities, and Training
Authors: Paul L. Pluta, Timothy J. Fields, and Alan J. Smith

“Compliance Case Studies” discusses compliance situations useful to practitioners in compliance and validation. Each case presented deals with a specific compliance problem, elements of which are described to demonstrate strategy to solve compliance problems. We intend this column to be a useful resource for daily work applications. The main objective of this column: Useful and practical information.

Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Case studies illustrating compliance issues submitted by readers are also most welcome. Please send your comments and suggestions to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS DISCUSSED
The following key points are discussed in this case study:
• A compliance case study involving manual cleaning, performance and responsibilities of manufacturing personnel, supervisors and quality control (QC) personnel, and training supporting all involved is discussed.
• The event comprised cleaning of manufacturing equipment per procedure. After cleaning and inspection by multiple personnel affirming successful cleaning, product residue was observed.
• Multiple issues were investigated including technical cleaning and cleaning procedures, clean equipment inspection procedures, responsibilities of supervision, QC responsibilities, documentation practices, adequacy of cleaning parameters, and the attitude of the organization toward cleaning and other quality activities.
• Investigation and root cause determination involved personnel interviews and cleaning procedure technical evaluation.
• Root cause was determined to be inadequate job performance by several
individuals.
• Corrective action and preventive action (CAPA) addressed the specific root cause as well as implementing multiple improvements to the site cleaning procedures, equipment inspection procedure, and the site-training program including multiple training initiatives.
• Post CAPA activities verified and maintained the continuing success of CAPA initiatives.
• Other activities prompted by this event were very significant for cleaning and associated activities. These demonstrated upper management concern and commitment to maintain quality standards.

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