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Quality Manual	8 – Operation
Section 8.1	Section Revision: A	Revision Date: 3/30/2017
8.1 – Operational planning and control
Approved By: Dave Zirkelbach		Date: 3/30/2017

GENERAL POLICY

Planning of product realization processes includes determination of requirements and quality objectives for products and services applicable to a product distribution-only environment; and establishment of processes, and documents, and to provide resources specific to the product. The plan also defines requirements for records necessary to demonstrate process and product conformity.

PROCEDURAL POLICIES

1. Product requirements and quality objectives

1.1 Product requirements and quality objectives (if applicable) for product are defined and communicated in customer orders submitted to Dee Electronics.

2. Product realization planning

2.1 Product realization planning includes, as applicable:

Development of adequate and capable processes,

Identification of special processes and consideration of associated risks and consequences,

Establishment and implementation of appropriate process control measures,

Development of instructions, documents, and training for process operators, and

Requirements for records necessary to demonstrate process conformity.

2.2 Product realization plans are established in collaboration between the President, CEO/Treasurer, Vice President of Operations, Operations staff, and Quality Assurance. The plans are defined in various types of documents, such as process flowcharts, work instructions, work orders, control plans, operator instructions, process validation reports, etc.

3. Product verification and validation planning

3.1 Product verification, validation, monitoring, measurement, and inspection plans determine the inspection program (if applicable) for a product or service. This includes:

Any applicable Identification of inspection points,

Any applicable Inspection scope, frequency, and method,

Any applicable Acceptance criteria, and

Any applicable Requirements for records necessary to demonstrate product conformity.

3.2 The President, Vice President of Operations, Vice President of Sales, Quality Assurance, Production Supervisor, and Distribution Supervisor are responsible for development of any applicable product verification plans. The plans are defined in various types of documents, such as specifications, special handling instructions, work orders, purchasing documents, inspection procedures, and so forth. Documents defining the inspection program for a product (if applicable) are collectively referred to as control plans.