Quality Policy.

A manufacturer’s Quality Policy describes the desired results for meeting quality specifications of products. The quality policy includes specifications on how the manufacturer meets regulatory requirements and how the QMS can be improved to meet organizational needs of continuous improvement. The quality policy applies to all employees involved in manufacturing.

Quality Planning.

Quality related matters are the direct responsibility of management and leadership. Quality planning is related to the quality policy, and internal auditing of meeting the specifications of that policy. All quality related matters must be supported to all personnel, and align with the quality policy. Key performance indicators of quality matters must be fully communicated and related to the quality policy.

Action you can take:

Start writing your organization’s quality policy by with making a list of the Critical Quality Attributes for each product being manufactured. Then write out what processes are related to each product, and what process specifications must be controlled in order to meet the product Critical Quality Attributes. These are the key steps to flesh out your quality policy.

You can not measure what you do not manage. Once you have a Quality Policy in place, you have set a baseline for managing your product quality. Develop a robust testing plan to measure your variation in meeting specifications. Develop in-process testing to ensure you are meeting process specifications before final release testing, and get the piece of mind that products are on track for meeting specifications before you send them to a 3rd party lab.

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