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Designing a Winning CAPA System

Larry Mager, VP of Quality and Compliance - PathWise CAPA is a critical Quality System subsystem that, when executed correctly, can provide your organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency. A CAPA System must be compliant, effective and efficient.

Compliant: The system

design satisfies regulations and requirements.

Effective: The system

works as designed. You get results.

Efficient: Work processes

are streamlined and require minimal resources necessary for execution.

So what is required of a CAPA System to make it compliant, effective and efficient? Let's take a look: Compliant CAPA System The applicable regulations and standards are dependent upon where your organization plans on selling its products or services. United States Europe ISO 13485 8.5.2 Corrective Action ISO 13485 8.5.3 Preventive Action 21CFR820.100 Corrective and Preventive Action

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MDD 93/42/EEC Annex II 3.1

Canada Japan JPAL Ministerial No. 169 Article 63 JPAL Ministerial No. 169 Article 64 CMDR SOR/98-282 Section 57 MDD 93/42/EEC Annex II 3.1

Once it is determined what regulations or standards are applicable, it is important to ensure those specific requirements are addressed procedurally and executed accordingly in order to be fully compliant. Being fully compliant, however, is not enough to be successful in CAPA. The regulations and standards define requirements that specify "what" to do but they do not specify "how". That is up to you, and appropriately so. Your success with CAPA is dependent on the "how" of CAPA in order to truly be effective in improving your organization.

Effective CAPA System In order to positively impact an organization, CAPA projects must address the most important issues and must do so in a way that desired results are obtained. How is this accomplished? Various sub-system elements of a Quality System (QS), business and manufacturing processes produce nonconformances. All relevant QS sub-systems must be designed to identify and correct their non-conformances. These QS sub-systems are also expected to operate within a state of "control." These QS sub-systems are unique and separate entities from the CAPA System, which is also a QS sub-system. There is, however, a hierarchical relationship between these QS sub-systems. QS sub-systems that produce non-conformances must have the ability to analyze and appropriately escalate non-conformances that are identified as either "high risk" or are the result of "out of control" process conditions. What does "appropriately escalate" mean? Wouldn't all identified non-conformances be escalated into CAPA? The answer is no. Doing so could cause the organization to become overwhelmed with the trivial many without properly addressing the significant few. It is important to understand that each QS sub-system nonconformance will be corrected. However, only those identified as "high risk" or are the result of "out of control" process conditions should be required to be escalated and formally addressed through a CAPA System. This system is designed to uncover the "root cause" of the issue and take corrective action in order to prevent the recurrence of the issue.

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Upon escalation of a non-conformance issue to CAPA, effectively addressing the problem is of paramount importance. The "infrastructure" of the process used to execute a CAPA project, the "how", will ultimately determine if the organizations improvement efforts are successful. Consider the various phases an effective CAPA process might go through in order for that work to be executed in an orderly manner:

Initiation ­ Phase where the identified issue is scoped and documented and becomes a CAPA Project. Investigation ­ Phase where the issue is investigated and the root cause is determined. Action Plan ­ Phase where the results of the investigation are turned into a plan of action for correction and/or prevention. Implementation ­ Phase where the execution of the action plan occurs. Verification of Effectiveness ­ Phase where the corrective or preventive actions are verified to be effective. Closure ­ Phase where the documented activity necessary to gain closure of the CAPA occurs.

These are all uniquely different phases in terms of the type of work conducted in each phase. It stands to reason that keeping a separate focus on these distinct phases of a CAPA project would enable the work output to be successful within each individual phase and for the CAPA project in aggregate. It is clear that the instructions for executing CAPA project work should be carefully built. The separate work components should be individually defined, yet housed within a system of documents that work together to accomplish the effective execution of CAPA projects. A CAPA System, however, consists of more than the project phases defined above. A properly designed CAPA System should consist of the following elements:

CAPA System Management ­ The requirements to manage the CAPA System as a business process. CAPA Projects Review ­ The requirements for review and management of CAPA projects. CAPA System Review ­ The process of analyzing the CAPA System Metrics and escalation to Management Review. CAPA Escalation Decision ­ The process of analyzing the severity of a non-conformance issue and documenting the outcome. This is the linkage between a QS sub-system that produces non-conformances and the CAPA System.

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CAPA Process ­ The requirements to execute and document the six phases of a CAPA project, as shown above. NC and CAPA Trending ­ The requirements to analyze and trend nonconformance quality data and CAPA project effectiveness.

The instructions for executing CAPA project work and the various additional elements of a CAPA System are unique and separate. The separate system components should be individually defined within a system of documents that work together to accomplish the effective execution of all CAPA activity within the organization. In their entirety, these documents then comprise the organization's CAPA System.

Efficient CAPA System A properly constructed CAPA System should consist of streamlined work processes that provide an organization with some significant benefits: In using appropriate escalation rules, the organization is less likely to become overwhelmed with the trivial many and can properly address the significant few non-conformance issues that arise from the QS sub-systems. By enabling a separate focus on the execution of the distinct phases of a CAPA project, the work output is capable of being efficiently completed within each individual phase resulting in a more successful CAPA project in aggregate. By enabling a distinct phases of a CAPA project work, with different required skill sets required for execution, CAPA project work is capable of being assigned by phase and in accordance with individual skills. Appropriate trending process will identify the "common cause" variation for non-conformance reduction improvement initiatives that can provide significant return in the investment of a CAPA project.

By designing and managing a CAPA System that is compliant, effective and efficient, organizations can expect to see fewer compliance issues and greater returns that ultimately improve the bottom line.

Larry Mager has over 15 years of experience in the life science industry. He has held responsible positions within medical device manufacturing companies ranging from start-up entrepreneurial ventures to large multi-national, highly matrixed corporate organizations. He has executed senior management responsibilities and coached teams in both Quality Management and Operations Management roles. Mr. Mager is experienced in interrelated disciplines such as,

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quality assurance systems, supplier management, onsite investigations, quality control, lean manufacturing, product development engineering and results oriented management for continuous improvement. Mr. Mager is a broad thinker with complete understanding of contemporary quality system practices enabling "out of the box" thinking for the design and implementation of sustainable systemic solutions. He possesses a global perspective and understanding of quality assurance requirements, and is able to effectively relate the quality function to the business as a whole.

Larry holds patents pertaining directly to cardiovascular products currently being marketed, and holds a Bachelor of Science in Mechanical Engineering from the University of Wisconsin.

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