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Quality Manual	6 – Planning
Section 6.1	Section Revision: A	Revision Date: 6/19/2017
6.1 – Actions to address risks and opportunities
Approved By: Dave Zirkelbach		Date: 6/19/2017

GENERAL POLICY

Quality objectives are established to support and implement the quality policy and continual improvement. Quality planning includes identification and determination of quality system processes (including any exclusions of ISO 9001:2015 requirements); priorities for continual improvement; and resources needed to achieve quality objectives and to maintain and improve the quality system. Quality plans are periodically reviewed and updated to maintain the integrity of the quality system during organizational and other changes.

PROCEDURAL POLICIES

1. Quality system planning

1.1 Quality system elements and processes are planned to ensure that the system is appropriate for its intended purpose, and that it is effective and efficient. The purpose of the quality system is:

To achieve the quality policy;

To ensure and demonstrate our ability to provide consistently product and services that meets customer and regulatory requirements;

To ensure high level of customer satisfaction;

To facilitate continual improvement; and

To comply with requirements of ISO 9001:2015 standard.

1.2 The output of quality system planning is documented in this quality manual, in associated operational procedures, and in other referenced documents. These documents identify and define all elements and processes of the quality system.

1.3 Changes to the quality system are planned within the framework of management reviews. These changes may be in response to changing circumstances, such as product, process, capacity, or other operational or organizational change; or to improve the effectiveness and efficiency of the quality system.

2. CORRECTIVE AND PREVENTIVE ACTION

2.1 Preventive versus corrective action

2.1.1 Preventive actions are requested and implemented when there are trends of decreasing quality capability and/or effectiveness of the quality system that create a risk for a potential nonconformity. Corrective actions are used when an actual nonconformity is identified.

2.1.2 Recognizing this difference, Dee Electronics has separate systems for identifying the need for corrective and preventive actions. However, once the need is identified, a common system is used to process both types of actions. Forms, logs and other documents and records for processing of corrective and preventive actions are the same.

2.1.3 Both corrective and preventative actions work to enhance all desirable effects on a case by case basis in all capacity.

2.2 Corrective actions

2.2.1 The need for corrective action is determined on the basis of identified actual nonconformities. Corrective action requests are typically triggered by such events as a failed inspection, customer complaint and/or product return, nonconforming delivery from a supplier, or a quality system audit finding.

2.3 Preventive actions

2.3.1 The need for preventive action is determined on the basis of information and data regarding capability and performance of processes, product nonconformity rates, post-order fulfillment experience feedback, customer complaints, quality system audit findings, and management review ideas.  Such information and data are collected and analyzed to detect unfavorable trends that, if not checked, will increase the risk of nonconformities. The system for collecting and analyzing quality performance information and data is defined in Section 8.4 of this manual.

2.4 Processing of corrective and preventive actions

2.4.1 Preventive and corrective actions are initiated, processed and followed up using a CAR  or Internal Audit/Management Corrective/Preventive Action Form.  The forms document the unsatisfactory condition and the corrective or preventive action to be taken, and is used to record the verification and closure of the action. Open CARs are reviewed regularly to ensure that the actions are implemented and followed up in a timely manner.

2.5 Continual improvement

2.5.1 Continual improvement actions are often defined as corrective and preventive actions. This is especially true for preventive actions.

2.6 Effectiveness of Corrective Action and Preventative Action

2.6.1 The effectiveness of Corrective Action and Preventative Action taken is reviewed and records of this are maintained in the Corrective Action log and Management Review Meeting Minutes.