What is a Quality Manual?

The Quality Manual documents all aspects of the organization’s policies and procedures of the Quality Management System. It is the 1000 Meter view (yes, we use the metric system) of how Product Quality is Managed, by managing the manufacturing process.

The quality manual can also include the Site Master File. The Site Master File explains all activities that take place within a Good Manufacturing Practices Facility, and is often the first place an auditor will look. It is often a document that is found to be out of date, and not matching the actual day-to-day operations in a manufacturing facility – that is why your organization should have the Quality Manual and Site Master File in good working order.

What are the elements of a Quality Manual?

  1. The Quality Policy is the organization’s stance on how they meet quality goals. It deliberately sets the standards of the organization’s quality goals. How can your organization meet quality goals if it does not have a policy in place? It is the corporate equivalent of a Mission Statement, except it directly relates to Quality.
  2. The scope of the Quality Management Systems describes what aspects of the manufacturing processes are controlled and monitored. The Quality Management System Scope will define what departments are affected, who is involved, and how quality related matters are handled.
  3. The description of the Quality Management System processes that are used to manage the manufacturing processes. This includes a Product Quality Assessment System (determines if Critical Quality Attributes are being met), Corrective Action and Preventative Action systems (to correct process problems and ensure they don’t happen again), Change Management Systems (ensure that Corrective/Preventative Actions are properly executed and closed out), and Management Review (to ensure processes are producing products meet Critical Quality Attributes).
  4. Management responsibilities describe the exact activities and responsibilities of leadership and management. Management is responsible for ensuring the process is being managed, instead of the labor being managed. Although it may seem to be redundant to suggest Quality Management Systems need to be Managed, it is the most essential set of responsibilities to ensure product quality is kept high. Management is most responsible for quality.

Action you can take:

Writing your Quality Manual takes time and careful thought. It requires complete knowledge of the manufacturing process, and understanding of the product lifecycle. At the very least, brainstorm how the elements of the Quality Manual and start putting together a rough draft. These documents do not spontaneously generate, and you will need to take an iterative approach that embodies the concept of “Continuous Improvement.”

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What is Knowledge Management?

Knowledge Management requires total characterization and understanding of the manufacturing processes that lead to product realization – these activities form the foundation for applying Quality Management Systems and define how process variables are controlled to meet product specifications.

What is Risk Management?

Risk Management is the activity of identifying and characterizing all risks associated with degraded product quality and Key Performance Indicators. There are many variables that can influence product quality, and those must not only be identified,

Actions you can take:

Process knowledge starts with the Six Process Variables:

  1. Raw Materials
  2. Equipment
  3. Facilities
  4. Process Steps
  5. Labor
  6. Management

Characterize these six variables for any process, and you gain understanding and knowledge of your manufacturing processes. Take each of those variables and then weigh the risks of where something could go wrong and reduce product quality. It sounds simple, yet so apply this basic step of risk management.

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