Quality Plan
A quality plan is a document, or several documents, that together specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract.
“A document or set of documents that describe the standards, quality practices, resources and processes pertinent to a specific product, service or project.”
The reasons for creating a quality plan and insisting on seeing your contract manufacturer's quality plan are many. The quality plan:
- Directs conformance to the customer’s requirements.
- Verifies your own external and internal standards and procedures.
- Provides traceability.
- Provides objective evidence.
- Indicates where training is needed.
- Offers insight into the effectiveness of the organization’s quality management system.
The reasons for creating a quality plan and insisting on seeing your contract manufacturer's quality plan are many. The quality plan:
- Directs conformance to the customer’s requirements.
- Verifies your own external and internal standards and procedures.
- Provides traceability.
- Provides objective evidence.
- Indicates where training is needed.
- Offers insight into the effectiveness of the organization’s quality management system.
What to Include in Your Quality Plan
- Goals/objectives - This should include the product specifications, use, aesthetics, cycle time, materials, and cost.
- Process steps or procedures
- Distribution of responsibilities - Who does what and when?
- Standards - What are the practices and procedures that need to be applied?
- Testing requirements - When does testing take place? Who performs it, and where?
- Change/modifications documentation procedure - Gives you a way to track changes to the project or process.
- Quality process measurement - A way to measure the value of the quality document itself.
- Other actions as needed to meet the objectives.
The quality plan prepared prior to this qualification event needs to be reviewed and followed to ensure every attribute has been qualified as per the plan. If new information is learned which should be included within the quality plan, then the plan should be formally updated to include such information.