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QMS Operational Procedure	QOP-71-01
Section 7.1	Section Revision: B	Revision Date: 2/2/2015
Control Plan Development
Approved By: Todd Gifford		Date: 11/15/14

I PURPOSE

The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities for creating assembly Control Plans.

II APPLICATION

This procedure applies to all assemblies.  This procedure concerns Assembly and Quality Assurance departments.

III PROCEDURE

1. DEE creates a Control Plan for each assembly or applicable assembly family that includes a PFD Process Flow Diagram, PFMEA, Control Plan, Work Instructions, and linked or relevant specifications and client requirements.  Training for developing Control Plans is identified in the Training Matrix.

2.  The PFMEA is created and identifies higher risk processes or components or CTQ Critical to Quality aspects of assembly.  Client CTQ Critical to Quality issues or aspects for assembly are requested by DEE and included in PFMEA/Control Plan where applicable.  Where there is a high risk process or component identified in the PFMEA, the following steps are taken:

2.1 High risk process – identify poke yoke/error proofing methods to eliminate risk, which could be systems or jigs, etc…

2.2  High risk component – request a Certificate of Analysis for CTQ aspect of component from supplier or request a PFMEA/Control plan from supplier or identify specific incoming inspection criteria and utilize for incoming inspection.

2.3 High risk process involving a tool or device with calibration requirements – identify a proactive assessment process to ensure proper calibration.  An example would implementation of an in-process quality inspection or measurement which proactively assesses proper calibration.

2.4 Quality Manager will sign off PFMEA of all control plans
3.  Control Plan is linked in System to Assembly Part # and only the most current version of the Control Plan is available to users.

ASSOCIATED DOCUMENTS

QM 7.1 Planning of Product Realization