Corrective and Preventive Action Procedure
3 Procedure
3.1 Request for Corrective Action
External and Internal customer complaints about product nonconformance are received directly. They deal with the customer and specify a time frame for a solution to his query, which can be updated, and the customer timely informed, after the discussion of the problem with the CPM and PM. The complaint and (if applicable) the returned product is passed on to the PM who analyzes the product and documents the results for record. He then initiates the corrective action request by completing the NCR (NCR-0020) and hands it over to the concerned department/section heads for analyzing and investigating the root causes and suggesting corrective plans suitable to the degree of the problem faced. Corrective plans are prepared on the Objectives Record (OR-0022).
For corrective actions resulting from audit findings, the auditor initiates a corrective action request by completing the NCR. MR reviews the NCR, and it is sent to the head of the concerned department who suggests corrective plans and upon approval, resolves the nonconformance within the specified timeframe.
For common/general/process problems, any person can point out/report the problem to his departmental head/section heads, who will initiate the corrective action to solve/correct/prevent the problem from recurrence.
MR maintains the corrective action log and stores it for five years.
3.2 Investigate Root Cause
To determine the root cause the department/section head shall analyze the following:
• Working methods
• Capabilities of the worker/operator
• Material
• Equipment
• Environment
He may apply various statistical techniques like, X-R chart, histogram etc. or to assess potential causes of nonconformity. The department/section head completes a report of the investigation and recommends solutions to prevent recurrence on the NCR MR/Auditor review the NCRs. The department/section head shall implement the approved plan and MR and PM shall check for its effectiveness. (See 3.6).
3.3 Execute Corrective Action System
The audited department head analyzes NC’s and suggests corrective plans to eliminate potential causes of nonconformance by completing the NCR. If an extension is needed, a request is initiated by auditee, stating the amount of additional time needed and reason for the extension. The request is filed with the MR.
The auditor/MR reviews the corrective action to indicate its effectiveness on the NCR and seeks GM approval. If rejected, the audited department head will review and reopen the investigation. If the problem is still not resolved, it is brought to GM and discussed in management review meeting. Upon approval, the MR ensures that the department/section head properly implements the corrective action instructions.
Where applicable, the corrective action shall be used to eliminate the cause of similar non-conformances in other existing or future activities.
3.4 Review of Corrective and Preventive Actions
In the management reviews meetings corrective and preventive actions are discussed, reviewed with the head of concerned department.
3.5 Resolved Corrective Actions
Resolved corrective actions are maintained in the Corrective & Preventive Action Log (CPL-4-021) by MR. If a change to a process or document is required, a Document Revision Request Sheet (DR-4-0009) is used to initiate the change (See QP-4.05).
In Charge Purchase handles disputes between the company and the supplier. Problematic suppliers are removed from the Approved Vendor List.
3.6 Verification of Effectiveness
Test data from inspection and testing and follow up audits (where applicable) are used to verify the effectiveness of the corrective action. The initiator of NC/auditor/MR follows the NC and examines the corrective action taken in order to determine if root cause of the problem is eliminated. If root cause is eliminated the NCR is closed.
3.7 Permanent Changes
The Head of concerned department can request a change to a design or process, system. Major changes are implemented after approval of GM.
3.8 Preventive Action System
Preventive actions will be performed on situations where non-conformity has been identified or a potential non-conformity is detected. Section in charges will take into account wide angled perspectives for detecting such situation. Typical sources of information may include studies of processes and work operations which affect product quality, audit results (internal or external), quality records, service reports and customer complaints. Proposals of improvement can be presented to the GM for preventive action of potential problems who in turn investigates the conditions of the proposal and where necessary approves the preventive action.
The department/section head evaluates the problem (actual or potential) or NCRs (if any) using methodology described in Section 5.2. If a potential nonconformity is determined, the MR completes the NCR. The GM PPF reviews the form and seeks Executive Director’s approval for the implementation of the preventive action in a specified time frame.
Preventive actions are also monitored by auditor/initiator to assess its effectiveness. If it is found effective, the NCR can be closed. Preventive actions are logged in the Corrective & Preventive Action Log which is maintained by the by the MR. Preventive actions taken will be discussed in Management Review meetings.