The key benefits of Control Plans include:
- Guides manufacturing in how to control the process and ensure product quality. During regular production runs, the control plan provides the process monitoring and control methods that will be used to control product and/or process characteristics.
- Provides the organization with the baseline to evaluate output, review the control plan, and make appropriate changes based on lessons learned and quality performance data.
- When utilized as “Family Control Plan” or “Foundation Control Plan”, allows a more efficient new product development and launch.
What are the key sections of the new manual?
The most noticeable change in the AIAG Control Plan reference manual (when compared with the previous Control Plan section inside the APQP 2nd Edition manual) is the clear description of control plan requirements and further clarification guidelines on how to effectively implement control plans, including their linkages with other quality assurance methods.
The main changes you will find in the new Control Plan manual are:
Detailed requirements and guidelines for topics based on past problems/opportunities: Control Plan format, Special Characteristics, Pass-Through Characteristics (PTC), Error Proofing Confirmation, Families of Control Plans, Interdependent Processes and/or Control Plans, Rework and Repair Processes, Reaction Plan Details, 100% Visual Inspection, “Black-Box” Processes, Non-Design Responsible Organizations, Direct Supply, and Use of Software to Develop and Manage Control Plans.
- Detailed guidance on how to develop control plans, not just form fields. Previously just described “Form Field content”, now includes description of how to obtain information and some minimum expectations, including:
- Frequency: if not 100%, must be volume-based and support containment,
- Reaction Plan: clarified expectation to include contain suspect product, stop the process from creating more suspect product, steps to bring the process back to control, and
- Reaction Plan: Requires inclusion of the “Owner/Responsible” for the Reaction, or reference to a detailed instruction document.
- Addition of “Safe Launch” requirements: must establish judgment criteria to exit Safe Launch, typically 90 days performance with no problems to customer and no problems identified by Safe Launch additional/enhanced controls/containment.
- The Production Control Plan is a living document and should be updated with lessons learned and other continuous improvement data sources.
- Consideration points for effective use of QMS and other elements related to Control Plan implementation, such as: Reverse PFMEA, Using Software to Develop and Manage Control Plan, Layered Process Audit as Control Plan Verification, Control Plans in Highly Automated Processes, Using Family/Foundation Control Plans and FMEAs, Control of Storage and Handling Related Risks, and Abnormality Management related to Control Plans.