Corrective Action Program

PURPOSE AND SCOPE

Purpose

To define the methods for preventive action, nonconformance trend identification, customer complaints/concerns and the issue of corrective action measures to ensure effective and timely solutions are taken to address root causes of problems.

Scope

The scope of this procedure is applicable to all customer orders, suppliers and our Company business processes.

RESPONSIBILITIES

General

Quality Assurance -  shall be responsible as follows:

     a.  Quality Assurance has the responsibility for the implementation and maintenance of this procedure.

     b.  Quality Assurance shall be responsible for initiating and tracking Internal Corrective Action Measurement as described in this                    procedure.

     c.  Quality Assurance shall have the responsibility for maintaining the status of, internal request for Corrective Action, or improvement.

Sales/Business Operations/Quality Assurance - shall be responsible as follows:

     a.  Sales/Business Operations/Quality Assurance shall be responsible for coordinating and preparing a response to all Customer                   (external) concerns or corrective actions.

           The Sales and Business Operations Departments are primary interfaces.

Purchasing/Quality Assurance - shall be responsible as follows:

     a.  Purchasing/Quality Assurance shall be responsible for sending and receiving SCAR forms from the Supplier in a timely manner.

Definitions

On-The Spot Corrective Action - is verbal corrective action initiated by QA Personnel and utilized to correct a nonconformance which is considered minor and non-reoccurring. 

If non-product oriented non-conformances are detected during an audit, the On-the-Spot Corrective Action shall be documented on the audit record form.

Formal Corrective Action -  is a documented request, initiated by Quality Assurance (Internal and Suppliers) or Customers (External), which requires the responsible supplier or our Company department to state in writing the root cause of the nonconformance, the action taken to eliminate the cause of the nonconformance and the date when the corrective action will take effect.
 

GENERAL REQUIREMENTS

General

The corrective action(s) system defined in this document starts with preventive action as a means of getting work accomplished. Preventive actions are initially applied during the planning of each Customer order and the design of new business processes. The intent is to focus on root causes of probable problems/concerns and implement solutions that prevent the problems/concerns from occurring. This document includes the following topics:

i    a.  Preventivie Actions

     b. Nonconformance Data

     c. Corrective Actions

     d. Customer Complaints/Concerns

     e. Management Review

Preventive Action

Quality Assurance/Business Operations determine actions needed to eliminate the causes of potential nonconformities in order to prevent their occurrence.  Preventive actions taken are appropriate to the effects of the potential problems. 

Preventive Actions are steps taken to prevent nonconformances from occurring versus re-acting to nonconformances.

Typical preventive actions include:

     a.  Reviewing Customer orders to ensure requirements are clearly defined

     b.  Examining prior process defect data (i.e. test/inspection yields and defect trends, etc.) before setting up processes for new                      products

     c.  Designing new processes in a manner that are mistake proof

     d.  Reviewing design documentation to ensure the information is accurate, complete and clear

     e.  Providing adequate time (i.e. scheduling) for processing products

     f.   Conduct hands-on training and providing proper communication to personnel involved in product quality

     g.  Ensuring proper tools/equipment and work environment are available to perform work activities

     h.  Preparing work instructions, as necessary, to clarify un-clear information

      i.  Preparing sample products and conducting first article inspections as necessary, and

      j.  Other

Nonconformance (NC) Data

NC, s relating to materials, procedures, supplies, audits and all other areas which affect product quality are documented maintained and analyzed by QA.  The means for documenting test/inspection results and non-conformances.  

Corrective Actions

The Corrective action forms used to identify issues requiring action are defined in this section and are prepared, approved and issued by Quality Assuranc e.

Corrective Actions Forms and Instructions

     a.  Requirements and instruction for filling out the Corrective Actions Request or Supplier Correct Action REquest forms are defined on the form.

     b. All initial and completed Corrective Action forms are retained electronically in the Connectwise Sharpvue CRM database retained in the Quality Assuance Area.

     c.  When a customer corrective action request is issued for a customer/vender deficiency, the request will describe the specific details of the defiency.

 

Customer (External) Concerns/Complaints

The Business Operations/Quality Assurance manager shall be responsible for tracking all customer concers/complaints or corrective action request.