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Quality Planning: What is it and why do we need it?
Quality planning is the identification and documentation of various activities within the quality management system that demonstrate control over the process to assure compliance. There are many different aspects to quality planning referenced throughout ISO standards and regulatory requirements, such as 21 CFR 820. Basically, a quality plan is a tool many auditors/inspectors look for to demonstrate you are managing quality activities in a controlled, systematic manner.
The Quality Policy, or your company, sets the stage to demonstrate your company commitment to quality in all activities. The Quality Manual is the strategic quality plan or roadmap documenting how your company will meet requirements of standards and regulations within the quality management system. Essentially, the Quality Manual could be considered equivalent to a business plan with a strategic focus on achieving quality in all processes and producst produced by the business unit. Some lower-level strategic quality plans could be:
· Regulatory strategy – outlines activities the business will pursue to assure regulatory compliance for submissions, geographic distribution and logistics, managing reportability and vigilance, etc.
· Product development pipeline – the strategy for launching new products or new generation products to the market through the development pipeline.
· Automation implementation – outlines the strategy toward automation tools that might impact quality systems/processes, such as document control, ERP, product lifecycle tools, CAPA, etc.
There are several other references to quality plans identified within the standards and regulations. These are usually more specific, short-term, and tactical. Some examples of these are:
· Design development plans – individual project plans documenting the design development activities for a specific product. This plan is different that a project plan, although there are some overlapping requirements.
· Internal audit schedule/plans – outlines the plan for completing the internal audit program for the facility.
· Site Master Validation Plan- A master listing of equipment and processes within the facility that require validation and/or re-validation. This plan is usually updated at least annually.
These examples are not meant to be all inclusive, but to try and distinguish between strategic and tactical types of quality plans. As we know, we are living in a world of transition and change. As projects or plans for change are identified throughout the year, they must be evaluated for potential impact on the quality system activities. Some examples of these types of activity include:
· Facility consolidation or move
· Quality System tool upgrades
· New OEM or supplier relationship.
These types of quality plans get much more specific and are part of the tactical quality planning activity.
As you can see, there are many types of business decisions and activities that have potential impact on the quality system, quality processes and/or product. Since the Quality Manual is a strategic quality plan, it makes good business sense to create an umbrella quality plan or master compliance plan that outlines various tactical quality plans with high-level goals and objectives. This is not meant to be redundant to lower level plans, but to provide a summary of activities for management with executive responsibility to keep track of transitions and changes. The master compliance plan can be used to demonstrate that the organization has control over all of the transition and tactical activities without having negative impact on the strategic quality plan. This master compliance plan should be a standing part of the management review meetings, and be updated as projects progress.
Remember, quality plans are just good business practice. Used properly, you will find they will help make transitions and change within the quality system more effective.
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 can be contacted at 678-480-5411 and cpark928@mindspring.com
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