Who Really Uses Your Quality Manual?

The best answer is everyone in the organization. From the CEO through the assembly line operators, this is the one document within your quality management system that everyone should use.
The various ISO standards (ISO 9001:2008 and ISO 13485:2007) require a quality manual as part of the documentation system. FDAs’s Quality System (QS) regulation (21 CFR 820) requires each manufacturer establish a quality plan defining the quality practices, resources and activities relevant to the devices. “The manufacturer shall establish how the requirements for quality will be met [820.20(d)].”
A well-written Quality Manual can meet the needs of the regulators, as well as employees when written as a roadmap to compliance for whatever standards or regulatory requirements your organization must meet. It is more than just a regurgitation of the requirements or standards.
Some key points to write the Quality Manual include:
· While the Quality Manual is a requirement for ISO and/or the FDA, this document should be written with the organization employees and management in mind. They should use the document much more frequently than the FDA or a Notified Body.
· Outline the Quality Manual based on either the ISO or QSR clause. FDA prefers to see the manual organized based on the QSR clauses, while ISO notified bodies prefer the ISO clause organized format.
· A cross reference matrix should be included as an appendix to the manual to demonstrate complete coverage of regulations and standards.
· The cross reference matrix should include the top-level document – policy, process, or procedure (if there is one) – to point the reader in the right direction for additional documentation and support. While the Quality Manual can be considered the Master Quality Plan, you may need to have a working quality plan that is updated more frequently. This plan is helpful to capture transitions and changes that are occurring in the business while they are being made. One example might be the consolidation and/or transition of multiple document control systems into one system.
· Each section of the manual should describe the approach your organization has taken to meet defined requirements. This should be a relatively high-level description, rather than minute details of the activity.
· Process interaction diagrams should be included in the manual. These can be drawn in many formats. The key is to demonstrate how the various processes interact with each other.
· Training on this manual and how to use it should be provided for all employees. They should be encouraged to reference it often.
· Don’t let it just sit on the shelf!

About the Author
B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large corporations, as well as small startup companies. Her industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com

B. Christine Park will also be conducting enKap’s upcoming webinar, “Defining the Documentation Lifecycle That Best Fits Your Organization,” September 8, 2011.
http://www.enkap.com/page/live-online-training-defining-the-documen...

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