Standard Operating SOP Corrective and Preventive Actions and Continual Improvement. Effective (or Post) Date: Document Origin BHRRL

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1 Standard Operating SOP Corrective and Preventive Actions and Continual Improvement Document Origin BHRRL Document Number: Effective (or Post) Company: SMILE Approved by: Imp Jan-08 BHRRL Heidi Hanes SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.

2 Title: Prepared By: Name, Title Munyaradzi P. Mangwendeza, Quality Manager Signature, Date Approved By: Name, Title Dr. Rosemary Musonda, Lab Director Signature, Date Review Date Revision Date Signature, Date Annual Review Distributed To: Location: Copy Number: Location: Copy Number Master file 1 Director 2 Dr. Musonda Director 3 Dr. Mine Lab Managers- Mr. S. Moyo Mrs. K. Makhaola 4 5 Lab Co-ordinator 6 Copy Number: Effective 01/02/2008 Page 1 of 9

3 1. General Policy 1.1. The quality system at BHHRL is geared towards the prevention of errors in laboratory services. To this end, a formal corrective and preventive action system is utilized Root causes of nonconforming test work, services, and quality system nonconformances are investigated, and corrective actions are implemented to prevent their recurrence BHHRL has implemented a continual improvement philosophy throughout the entire organization, which is driven by goals documented in the quality objectives and quality policy. Opportunities for improvement are identified and translated into improvement projects. Causes of non-conformance are identified, investigated, and where appropriate, corrective actions are implemented to ensure there is no recurrence. Preventive actions are implemented to eliminate the causes of potential non-conformances. 2. Purpose 2.1. To establish and specify systematic steps for corrective and preventive actions in the resolution of quality related problems To create permanent solutions that prevent recurrence of non-conformities To establish the process to identify, track, complete the investigation of the problem and correct the causes of existing non-conformances including complaints in test work, processes, the BHHRL Quality Management System, and services in the BHHRL as well as institute preventive actions To ensure that Continual Improvement Procedures are identified and implemented in a standard and correct manner The cornerstone of preventive and corrective actions and continual improvement is written and retrievable documentation of actions taken and follow-up monitoring to determine that corrective actions have been performed and documented and preventive actions have been implemented and documented. 3. Scope 3.1. The procedure applies to the internal and external customer related reliability, safety, or quality of any test, equipment used or service offered by BHHRL Any written or oral expression of dissatisfaction by either internal or external customers related to the identity, quality, reliability, safety or use of any test result, equipment used or service offered by BHHRL is subject to investigation for root cause and irreversible corrective and preventive action. Effective 01/02/2008 Page 2 of 9

4 4. Responsibilities 4.1. Quality Manager: Serves as the focal point of data quality, instrument problems, report and action quality and for feedback on operations and corrective actions Establishes corrective action and problem report form and procedure; Monitors the progress and status of corrective actions for timely completion, Reviews completed CAPR forms for effectiveness and assigns follow-up actions and date due, if deemed necessary; Maintains corrective action and problem report (CAPR) form database Maintains and files copies of objective evidence which support verification and validation of corrective and preventive actions taken Verifies implementation of management review action plans Maintains action plans and their relevant documentation Records all corrective actions in the corrective actions status log Detects and corrects systematic problems which may occur in the course of daily work by maintaining surveillance over stated quality objectives and requirements, audits and complaints Enforces all continual improvement activities Assigns a sequential number which serves as the tracking mechanism for all CAPR forms Staff: Initiates and performs corrective action for non-conformances Complete corrective action and problem report form to document problem, area or situation investigated, findings and action taken Initiates and performs identified preventive action Corrective action at the technical level is initiated and corrected by the laboratory scientist or supervisor. The person who discovered the problem should be involved in correcting it. 5. Preventive Actions Procedures 5.1. Preventive action plans are part of a proactive process for improvement rather that a reaction to problems or complaints. Preventive action includes the use of sources of information such as processes and work operations which affect quality, audit results, quality records and complaints to detect, analyze and eliminate potential causes of non-conformances When corrective actions are implemented, needed improvements are identified, or when a potentially serious non-conformance is identified, similar lab tests and Effective 01/02/2008 Page 3 of 9

5 processes are analyzed to determine the required steps for effective implementation of preventive actions If preventive action is required, action plans are developed, implemented and monitored Preventive action includes the use of measurable quality objectives and requirements, validation and review processes, audits and management review, feedback and complaints, and the quality system and the ISO/IEC requirements Proficiency samples, internal quality control samples and quality control (QC) charts are monitored for trends or biases The laboratory performs function verification and preventive maintenance on instrumentation. Service contracts with periodic manufacturer maintenance are in effect for identified instruments Documented investigation using the corrective action form is initiated if a potential nonconformity is identified from any of the above processes The preventive action process consists of: Reviewing potential problems; Deciding the potential cause of the problems; Deciding the course of action to eliminate the problem from occurring; Putting the plan into action then; Ensuring or verifying the action solved the problem or is effective over time Monitoring the information and effectiveness of the preventive action is accomplished by any of the following: Control and process charts; Performance measurements and training; Customer inputs; Employee suggestions and inputs; Audits and management reviews; and Management meetings 6. Corrective Actions Procedures 6.1. Corrective actions may be requested when a condition, which is adverse to quality or which has the potential to process improvement is identified. This includes nonconforming reagents materials etc received from suppliers All corrective actions start with an investigation to determine the root cause(s) of the problem. A thorough analysis of all related processes, operations, quality records and specifications, which may have contributed to the deficiency, is conducted by the responsible people. All potential corrective actions are Effective 01/02/2008 Page 4 of 9

6 identified and the actions most likely to eliminate the problem and to prevent recurrence are selected The investigation and analysis of the root cause and preventive measures shall be fully documented by the group or individual assigned to the problem. The analysis shall include review of all applicable data to determine the extent and cause of the problem and analysis of trends in processes or performance of work to prevent non-conformances All problems are evaluated in terms of potential impact on quality costs, performance, reliability, safety and customer satisfaction. All problems are classified as either minor or major. Resolutions to all corrective and preventive actions are to a degree appropriate to the magnitude and risk of the problem. Resolutions are reviewed and approved by the Quality Manager. Where the response is unsatisfactory; the corrective action request is re-issued. The Quality Manager conducts periodic reviews/follow-ups to determine if the corrective and preventive actions have been implemented and are effective Every effort is made to ensure that the customer s concerns are addressed Procedural Steps: The investigation of suspected quality problems is initiated as a result of quality control criteria being exceeded, specified requirements not being met, audit findings indicating systematic problems, or as a result of a complaint When a non-conformity is detected, suspend affected work and evaluate the situation. Take action to identify non-conformance. Obtain Corrective Action and Problem Report (CAPR) form and fill in the necessary details and begin investigations to resolve the problem The findings from investigations are recorded on the CAPR form. Examples of findings or causes include: Equipment failure; Incomplete or nonexistent procedures; Non-compliance with procedures and regulations; Improper collection, storage, handling, or preparation of samples or reagents; Calculation errors or transcription errors; and Lack of training Note findings and causes with supporting evidence The cause and, if possible, the root cause, is determined to prevent recurrence of the non-conformity and to provide a permanent solution Decide action to be taken. Perform corrective action. Effective 01/02/2008 Page 5 of 9

7 Submit CAPR form to immediate supervisor and/or Laboratory Manager for review and approval. The Section Supervisor/Laboratory Manager will review and perform one of the following actions: Not approve the actions taken and recommend further actions to be taken. Additional corrective action will be implemented, reviewed and approved Approves the action or recommends further action Approve the corrective action and enter in name and date on form and submit the CAPR form and supporting documentation to the Quality Manager within 30 days of date action initiated The Quality Manager reviews, evaluates and determines effectiveness of actions taken. The process may be approved and closed or further follow up actions may be identified and returned, or determined to be ineffective, and a corrective action process initiated to correct nonconformity Examples of conclusions and actions may include: Equipment repaired, Procedures revised or created, Product reworked to comply with procedures or regulations, Correct calculation employed or transcription error corrected, and Proper training given Corrective actions are of two kinds: On-the-spot or immediate corrective action to correct or repair nonconforming data, reporting or equipment, that are actions routinely made by laboratory staff and supervisors; and Long-term corrective action to eliminate causes of non-conformance or a complex deficiency that are actions normally identified by audits 6.7. CAPR form A CAPR form is used to report the non-conformity. This form provides the steps for a closed-loop process that includes: Initiation and identification of nonconformity, Investigation (examine extent), Findings and conclusions, Determination of cause to prevent re-occurrence, Corrective action taken and implemented, and Follow-up by the Q Manager to ensure that the corrective action worked and succeeded in achieving the results desired and is effective. Effective 01/02/2008 Page 6 of 9

8 Work is suspended and evaluated. Action is taken to identify the nonconformance. 7. CAPR form: Quality Manager and Follow-up: 7.1. The Quality Manager reviews the form and evaluates the implementation and effectiveness of the corrective action (e.g. Are quality objectives met?) If deemed necessary, follow-up actions will be identified and a new date for completion set and approved When there is objective evidence that the actions are completed and effective, the Quality Manager approves and closes the CAPR If the CAPR was initiated due to a complaint, the CAPR is not closed until the customers have been contacted and confirmed that their concerns have been met. See Handling Complaints BHHRL/001PR The nature of the non-conformity and status of this process is reported to the Laboratory Director monthly by the Quality Manager. 8. Results Release 8.1. Data, reports, and action plans are not released until the problem is resolved and verified by the Laboratory Manager and the Quality Manager. The sample may need to be reanalyzed or re-collected or the audit redone. If unable to resolve the problem, the client is notified that the laboratory data cannot be reported or accepted; with disclaimers made that the results did not meet quality standards In the event that a non-conformity has been identified and previous reported data/information is suspect, the customer is notified and if possible the results brought into limits by rework or reanalysis to confirm the validity of what was reported. If in error, a corrected report will then be sent. 9. Continual Improvement Procedures 9.1. BHHRL has implemented a continual improvement philosophy throughout the entire organization. This philosophy is inherent in the BHHRL Quality System. Every employee in the organization is encouraged to suggest new ideas for improving tests, processes, systems, productivity, and the working environment Opportunities for improvement of operations and processes are identified by Section Supervisors on a continual basis from daily feedback on operations and periodic management reviews. Opportunities for improvement of services are identified mainly by Laboratory Manager and the Quality Manager. Effective 01/02/2008 Page 7 of 9

9 9.3. Sources for Improvement Opportunities Inputs for improvement opportunities are obtained from the following sources: Customer satisfaction and any other customer feedback Market research and analysis Inputs from employees, suppliers, and other interested parties Internal and external audits of the Quality System Records of non-conformances; Data from process and test results including quality control results characteristics and their trends Opportunities for improvement may also be identified on a special project basis. The following are examples of such projects: Non value-added use of floor space Excessive retesting of samples Excessive handling and storage problems Excessive failure resulting in quality costs Equipment set-up changeover times 9.4. Evaluation, Prioritization, and Implementation Opportunities for improvement from daily feedback on operational performance (i.e., disposition of nonconforming test results, internal audits, customer complaints, etc.) are evaluated by the Quality Manager. Typically, they are implemented through the corrective and preventive action system Opportunities for improvement from analysis of longer-term data and trends are evaluated and implemented through the Management Review process. They are prioritized with respect to their relevance for achieving quality objectives. When opportunities for improvement are no longer supported by the current policy and objectives, management will establish new quality objectives, and possibly change the policy. The process for this evaluation and prioritizing is described in the Management Review Procedure. Longer-term improvement projects are initiated through the management review process, as well as the corrective and preventive action system Service improvement opportunities are evaluated by Laboratory Manager, Quality Manager, and the Director. 10. Quality Assurance and Quality Control Where the identification of non-conformances or departures of nonconformances or departures casts doubt on compliance with policies and Effective 01/02/2008 Page 8 of 9

10 procedures or with ISO/IEC 17025, appropriate areas of activity are audited in accordance with the SOP on internal Audits. This is typically only necessary when a serious issue or risk to the operations, results e.t.c. is identified The effectiveness of corrective actions are monitored and verified during audits and management review 11. Records Corrective Action and Problem Report (CAPR) form CAPR database Corrective Action log Action plans Audit reports IQC, EQA Reports 12. Co-applicable Documents Internal Audits Handling Complaints Root cause analysis Management Review Document Control and Management Records and Data Control Purchasing and Receipt Control of non-conforming work 13. Attachments Corrective Action and Problem Report Form Revision History: Revision Revision Level: Revised By: Brief description of revision: Effective 01/02/2008 Page 9 of 9

11 Corrective Action and Problem Report (CAPR) Form Effective 01/02/2008 Initiated by: Nature of problem: Potential Non-Conformity Actual Non-conformity Description of the Problem: Stop Work? No Yes Information to hold results communicated? No Yes To: Reported to: Supervisor/Manager Comments: Assigned to: Due Action Taken by assigned staff member: Root Cause of Problem: Impact on Operations/Results/Patient Care: Signed: Disposition: Retest Re-collect Accept/Use-as-is Reject Limited Use Repair Training Ammend Report Long-term corrective action to prevent recurrence: Lab Manager Review Approval: No Yes Comments: Due Date Quality Manager Review:Corrective action: Effective: Not Effective: Follow-up Needed No Yes Due Comments: Sign: Further Action Required: No Yes Action Description: Assigned to: Description of Method and results of CA verification (e.g. assessment, inspection, surveillance): Due Auditor sign-off: Supervisor sign-off: Laboratory Manager sign-off: Quality Manager sign-off: