GENERAL POLICY
Planning of product realization and control 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, CTQ’s (Critical to Quality) Elements, and quality objectives (if applicable) for product are defined and communicated in customer orders and specifications submitted to Harrington.
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, General Manager of Manufacturing, Operations Manager, 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, General Manager of Manufacturing, Senior VP President of Sales, Quality Assurance, Operations Manager, and Supervisors/Leads 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.
Referenced Procedure
Revision History:
| Revision | Date | Description of Changes | Approved By |
| 0.0 | 07/03/17 | Initial Release | Jim Theesfeld |
| 1.0 | 8/17/18 | Digitized version | Todd Gifford |