Documentary Procedure for Identification and Control of Non-Conformities
1. Purpose The purpose of this procedure is to ensure that all non-conformities, which could negatively impact the accuracy of laboratory results or patient safety, are detected, documented, and properly addressed. It outlines a systematic approach to control deviations from standard practices and regulatory requirements. Ensure consistency and compliance: All laboratory processes must follow strict guidelines to meet quality standards (e.g., ISO 15189). Any deviations need to be controlled quickly to maintain consistency and adherence to regulations. Protect patient safety: Errors in sample collection, processing, or reporting could result in incorrect patient diagnoses or treatment. Identifying and controlling non-conformities promptly can prevent harm to patients. Continuous improvement: The procedure encourages ongoing quality improvement by documenting all non-conformities, analyzing their causes, and implementing corrective actions to prevent recurrence.
2. Scope This procedure applies to every phase of the laboratory workflow (pre-analytical, analytical, and post-analytical), ensuring that non-conformities are identified, no matter where they occur. It applies to all employees, processes, equipment, and external services.
Pre-analytical phase: Mistakes during the pre-analytical phase, such as improper sample collection, labelling errors, or delays in transport, can affect the integrity of the samples and result in inaccurate test outcomes.
Analytical phase: Equipment malfunctions, reagent issues, or improper use of testing protocols can result in incorrect test results. Non-conformities during this phase must be addressed immediately.
Post-analytical phase: Errors can occur during the reporting of results or the communication of critical values to healthcare providers. This is especially important since reporting errors may lead to wrong clinical decisions. The scope also extends to any materials, suppliers, or outsourced services that the laboratory uses, which can impact laboratory performance.
3. Definitions Providing clear definitions of the terms used in the procedure helps ensure that all personnel understand what constitutes a non-conformity and what actions are required.
Non-Conformity: This refers to any situation where actual performance fails to meet set expectations, standards, or regulations. It includes anything from procedural errors to equipment malfunctions. Example: If the lab receives a sample outside of the proper temperature range, this is a non-conformity.
Corrective Action (CA): Once a non-conformity is identified, steps must be taken to correct the immediate problem. These actions aim to fix the issue at hand and prevent it from affecting future work. Example: If a reagent is found to be expired, the lab will discontinue its use immediately and replace it with a new batch.
Preventive Action (PA): In addition to corrective actions, preventive measures are designed to stop the problem from recurring. They address the root causes to improve processes long-term. Example: After addressing the expired reagent issue, the lab may update its inventory control system to ensure reagents are checked for expiration dates regularly.
Root Cause Analysis (RCA): This is a method of investigating the reasons behind a non-conformity. It digs deep into the issue to uncover the underlying cause, allowing more effective preventive measures. Example: Asking, “Why was the expired reagent used?” might reveal that staff wasn’t trained properly or that inventory logs were not regularly checked.
Containment: Immediate actions taken to minimize the damage of the non-conformity until a full investigation is completed and corrective actions are in place. Example: Halting tests on a faulty machine to prevent invalid results until the machine is serviced.
Non-Conformance Report (NCR): The document used to record and track non-conformities.
4. Responsibilities This section clearly defines the roles of all personnel involved in managing non-conformities, ensuring accountability and timely action.
- Quality Assurance (QA) Department: Oversees the implementation of the SOP and ensures compliance with regulatory requirements.
- Quality Control (QC) Department: Identifies and documents non-conforming materials during testing or inspection activities.
- Laboratory Staff: All staff members are responsible for staying vigilant and reporting any errors or deviations they observe in their daily tasks. This creates a culture of continuous quality monitoring.
Example: A technician notices that a sample’s label is missing critical information, so they immediately inform their supervisor.
- Section Heads/Supervisors: They are tasked with the initial investigation of the non-conformity. They oversee the documentation process and ensure that containment actions are implemented until the problem is resolved.
Example: If equipment malfunctions, the supervisor must ensure the equipment is taken out of service and that alternative procedures are in place to continue operations.
- Quality Manager: The quality manager oversees the overall process of managing non-conformities, ensuring that the laboratory consistently applies the procedures. They evaluate non-conformity reports, initiate root cause analysis, and implement corrective actions.
Example: The quality manager conducts trend analysis of non-conformities over time to identify systemic issues and recommend laboratory-wide improvements.
- Laboratory Director: The director’s involvement is typically required for critical non-conformities that pose a significant risk to patient safety or regulatory compliance. They are responsible for approving major corrective actions.
Example: A critical equipment failure leading to incorrect test results requires the director to review and approve any high-impact corrective actions.
5. Procedure
5.1 Identification of Non-Conformities Non-conformities can arise at any point in the laboratory workflow. These include:
Pre-Analytical: Sample misidentification, incorrect sample collection, inadequate transportation or storage conditions, mislabeled containers.
Analytical: Equipment malfunctions, use of expired or improperly stored reagents, deviations from standard procedures, incorrect calibrations, or control failures.
Post-Analytical: Errors in data transcription, incorrect reporting of results, delays in result delivery, or failure to communicate critical values.
5.2 Reporting and Documentation of Non-Conformities
Immediate Reporting: When a non-conformity is identified, laboratory staff must report it to their supervisor or section head within the same shift. Documenting the Non-Conformity: The supervisor or staff member must complete a Non-Conformance Report (NCR), providing the following details: Date and time of occurrence. Description of the non-conformity. Equipment or process involved. Immediate actions taken to contain the issue. Personnel involved or impacted by the issue.
NCR Submission: The completed NCR is submitted to the Quality Manager within 24 hours of identification.
5.3 Initial Assessment and Containment Initial Assessment: The Quality Manager reviews the NCR to assess the impact of the non-conformity on laboratory results, patient safety, and regulatory compliance. Containment Actions: Immediate actions are taken to minimize the impact of the non-conformity, such as: Quarantining affected samples or reagents. Stopping the use of faulty equipment. Notifying clinicians about potentially compromised results. Containment actions must be documented in the NCR and tracked by the Quality Manager.
5.4 Categorization of Non-Conformities Non-conformities are categorized based on their severity:
- Minor Non-Conformity:
Low impact on quality, patient safety, or compliance, requiring correction but not immediate containment.
- Major Non-Conformity:
Significant deviations that may compromise the quality of results or workflow, requiring timely corrective action but posing no immediate threat to patient safety.
- Critical Non-Conformity:
Non-conformities that pose a direct risk to patient safety, regulatory compliance, or operational continuity. These require immediate containment and escalation to senior management. The categorization guides the level of investigation and the urgency of corrective actions.
5.5 Investigation and Root Cause Analysis
- Root Cause Analysis (RCA):
For all major and critical non-conformities, an RCA must be conducted by a team led by the Quality Manager. The RCA aims to identify the underlying cause of the non-conformity.
- RCA Tools:
5 Whys Analysis: Asking “Why?” repeatedly until the root cause is identified. Fishbone Diagram (Cause-and-Effect): A visual tool that categorizes potential causes into various factors (e.g., personnel, equipment, environment).
Investigation Process: The RCA team will: Review relevant documents, processes, and equipment logs. Interview staff involved. Examine environmental or procedural factors. The RCA findings must be documented in the NCR.
5.6 Corrective and Preventive Actions (CAPA)
- Corrective Action Plan:
Based on the RCA, a Corrective Action Plan (CAP) is developed, outlining specific actions to address the root cause of the non-conformity. The CAP should include:
- Steps to eliminate the root cause.
- Responsibilities for implementing the actions.
- Deadlines for completion.
Example Actions: Updating or revising SOPs. Retraining staff. Repairing or replacing equipment.
- Preventive Action Plan:
Measures to prevent similar non-conformities from occurring in the future. This may include proactive actions like strengthening quality control, monitoring processes more closely, or implementing additional safety checks. Approval and Implementation: The CAP must be approved by the Quality Manager, and for critical non-conformities, it must also be approved by the Laboratory Director. The responsible team implements the actions within the defined timeframe.
5.7 Verification and Closure of NCR Verification of Corrective Actions: After the implementation of corrective actions, the Quality Manager verifies their effectiveness by: Reviewing updated processes. Monitoring subsequent results or outcomes. Conducting audits to ensure compliance with the new procedures. Closure of NCR: If the corrective actions are deemed effective, the non-conformity is closed, and the NCR is signed off by the Quality Manager. If the actions are not sufficient, further actions may be required before closing the NCR.
5.8 Monitoring and Trend Analysis Tracking Non-Conformities: The Quality Manager maintains a Non-Conformity Log, documenting all NCRs, their categories, root causes, and corrective actions. This log is regularly updated and reviewed. Trend Analysis: The Quality Manager conducts a monthly or quarterly analysis of non-conformities to identify trends and recurrent issues. This information is shared during quality review meetings and used to improve processes or implement system-wide preventive actions.
6. Records
The following records must be maintained as part of this procedure:
- Non-Conformance Reports (NCR)
- Root Cause Analysis reports
- Corrective and Preventive Action (CAPA) plans
- Verification records
- Quality Control logs
- Equipment maintenance records
- All records must be retained for at least five years in compliance with regulatory requirements and laboratory policies.
7.References
- Relevant standards and guidelines that guide the laboratory’s quality management system, such as:
- ISO 15189 (Medical Laboratories – Requirements for Quality and Competence).
- Clinical and Laboratory Standards Institute (CLSI) guidelines.
8.Conclusion: This procedure provides a structured and standardized approach for identifying, documenting, investigating, and controlling non-conformities in the clinical laboratory. It ensures that laboratory processes remain consistent, accurate, and compliant with regulatory standards.