Saturday, March 1, 2014

SOP: Nonconformity, corrective action and preventive action


1.0 GENERAL
 

Scope:

2.0 DEFINITION 


3.0 RESPONSIBILITY AND AUTHORITY


      Safety Manager:
      • Responsibility: <define the function>
      • Accountability: <define the function
      • Authority: <define the function>
      OSHMR:
      • Responsibility: <define the function>
      • Accountability: <define the function
      • Authority: <define the function>
      SHO

      • Responsibility <define the function>
      • Accountability <define the function>
      • Authority <define the function>
      4.0 CONTROL PROCEDURE

      • Identification of non-conformity can be defined as following inputs;
      • Identification of potential non-conformity can be defined as following inputs;
        • Any feedback received from interested parties with respect to potential occurrence and incident that may happened with respect to the OH&S matters as partly defined in the SOP: Communication, participation and consultation.
        • Any finding under category of opportunity for improvement raised during internal and/or external audit.
        • Potential non-conformity Issue highlighted during management review where decision made by <who> for action need to be taken.
      • Corrective Action and Preventive Action Requisition;
        • Whenever a nonconformity / potential nonconformity are identified, immediately highlight and report to <who> for confirmation. In case of Internal Audit, Lead Auditor has full authority in making on his decision.
        • <who> or Auditor (in Internal Audit) shall verify and record the potential problem / nonconformity in the <CPAR> form. Where necessary or serious failure potentially may occurred, <who> shall than call respective person and arrange for meeting. Input of meeting then will be used in determining root caused and measures need to be taken.
      • Investigation of the problem and Determining Root Cause
        • Respective process owner shall investigate the problem and evaluate its significant and impact on OH&S.
        • The root cause of the problem shall be determined and a suitable solution to the non-conformity shall be initiated.
        • Evaluations of the nonconformities shall indicate what corrective actions to take to eliminate the root causes of the nonconformities or potential nonconformities.
      • Determining and Implementing Corrective and/or Preventive Action
        • The corrective action shall be initiated to a degree appropriate to the magnitude of the incident or non-conformity and it shall prevent further recurrence.
        • The personnel responsible in providing and implementing the corrective action shall complete the <CPAR> with the following information :-
          • Action Proposed to prevent recurrence so as action taken to rectify the problem.
          • Date which the corrective action shall be completed.
          • Where appropriate, analysis and support data is necessary to address the potential occurrence of problem.
        • The <team… or who> shall analyze all relevant data/record to identify the cause of the potential nonconformities, the need for action, determining and implementing the actions needed to prevent occurrence of nonconformities.
        • The completed <CPAR> shall be submitted to the <OHSMR> for attention.
        • The CPAR shall be reviewed together with the Managing Director and/or QMR upon approval of the proposed corrective action, the implementation shall be carried out.
      • Verification of Action
        • The <OHSMR> shall verify that the corrective and/or preventive actions are taken and are effective.
        • If the action taken is not effective in resolving the problem, the <OHSMR>  shall bring it to the attention of the relevant party concerned and another corrective action plan may be initiated.
        • If there any <CPAR> is unable to close within the dateline given, QMR should get feedback from the relevant parties and stating the valid reason of unclosed issue.
        • At time, the action implemented may result in changes of affected documents; the personnel concerned shall follow the procedures stated in Control of Documents for any amendments.
      • Reviewing Corrective & Preventive Actions
        • Result of <CPAR> shall be discussed during management review by <who>
        • The purpose of discussion in the management review is to ensure the effectiveness of implementation of the corrective and preventive actions
      • jihiuhui


      5.0 CROSSED REFERRENCE SECTION

      6.0 RECORDS
      • CPAR

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