If this document is printed or copied, it is an uncontrolled document
| Quality Manual |
10 – Improvement |
|
| Section 10.2 | Section Revision: B | Revision Date: 11/10/2020 |
| 10.2 Nonconformity and corrective action | ||
| Approved By: Dave Zirkelbach | Date: 6/19/2017 | |
GENERAL POLICY
Nonconforming product is identified, documented, evaluated, and prevented from being used or shipped. Appropriate actions are taken when product nonconformity is identified after delivery. When appropriate, corrective and preventive actions are implemented to prevent recurrence of identified nonconformities.
The quality system described in this section of the Quality Manual conforms to the requirements of the ISO 9001:2015 standard: Element 10.2 – Nonconformity and Corrective Action.
1. RESPONSIBILITY AND AUTHORITY (R&A)
The R&A for carrying out quality system activities related to this element have been assigned to the President. All associates have the responsibility to carry out their work assignments in accordance with the quality policy and quality system documentation. The associates have been granted appropriate authority to complete the activities assigned in order to meet specified requirements.
2. CONTROL OF NONCONFORMING PRODUCT
Dee Electronics has established and maintains documented procedures to ensure that nonconforming product is prevented from unintended use or installation. This control provides for identification, documentation, evaluation, segregation, disposition of nonconforming product, and notification to the functions concerned.
2.1 Review and Disposition of Nonconforming Product – Dee Electronics has defined the responsibility for review and authority for the disposition of nonconforming product. Nonconforming product is reviewed in accordance with documented procedures. Where applicable, it may be reworked to meet the specified requirements, accepted without repair by concession, rejected/returned, or scrapped. Dee Electronics does not do Repair. When nonconforming product is corrected, it is subject to re-verification to demonstrate conformity to the requirements.
2.2 Where required by contract, the proposed use of product which does not conform to specified requirements is reported for concession to the customer or customer’s representative. The description of the nonconformity that has been accepted is recorded to denote the actual condition. Reworked product is re-inspected in accordance with documented procedures.
3. PRODUCT RETURNS and CONTAINMENT
3.1 When product nonconformity is detected by the customer after delivery or use has started, the customer is instructed to return the product, and a Return Authorization/Corrective Action (RMA/CAR) is issued by Inside Sales (Customer Service). The containment process is initiated and any additional sites are notified as needed.
3.2 When product nonconformity is detected internally after delivery or use has started, customers are informed about containment and instructed what to do with the product via RMA/CAR.
4. CORRECTIVE AND PREVENTIVE ACTION
4.1 Preventive versus corrective action
4.1.1 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.
4.1.2 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.
4.2 Corrective actions
4.2.1 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.
4.3 Preventive actions
4.3.1 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.
4.4 Processing of corrective and preventive actions
4.4.1 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.
4.5 Continual improvement
4.5.1 Continual improvement actions are often defined as corrective and preventive actions. This is especially true for preventive actions.
4.6 Effectiveness of Corrective Action and Preventative Action
4.6.1 The effectiveness of Corrective Action and Preventative Action taken is reviewed and records of this are maintained in Management Review Meeting Minutes.