LABORATORY STANDARD OPERATING PROCEDURES
FACILITY NAME: CITY EYE HOSPITAL
SOP Title: QUALITY CONTROL (QC) AND QUALITY SOP No: 00
ASSURANCE (QA)
Version: Original
Effective Date: January 2024 Page 1 of 16
Signatures and Dates:
Author: _
LABORATORY MANAGER Date
Review:
LABORATORY TECHNOLOGIST Date
Approving Authority:
QA MANAGER Date
Review/Approval for unchanged documents
DATE Author QA Review Approving Authority
CEH/LAB/SOPs
Objective:
To establish and maintain a systematic approach for quality control and assurance in laboratory
processes, ensuring accurate and reliable results, and compliance with regulatory standards.
1. Quality Control (QC) Procedures:
1.1 Routine QC Checks:
1.1.1 Frequency:
Specify the schedule for routine QC checks (daily, weekly, monthly).
Define the frequency of specific checks for different tests and instruments.
1.1.2 Critical Parameters:
Identify and document the critical parameters to be monitored for each test.
Establish acceptable ranges and limits for each parameter.
1.1.3 Documentation:
Record all QC data accurately and consistently.
Outline procedures for documenting and archiving QC data.
1.2 Instrument Calibration and Verification:
1.2.1 Frequency:
Define the frequency of instrument calibration and verification.
Specify the procedures for calibration and verification.
1.2.2 Acceptance Criteria:
Document criteria for acceptance and correction of calibration deviations.
Outline the steps to be taken if an instrument fails calibration.
1.3 Reagent Quality Control:
1.3.1 Storage and Handling:
Specify proper storage conditions for reagents.
Document procedures for handling and storing reagents.
1.3.2 Quality Checks:
Establish procedures for checking the quality of reagents.
Document criteria for accepting or rejecting reagent batches.
1.4 Internal QC Samples:
CEH/LAB/SOPs
1.4.1 Usage:
Describe the use of internal QC samples in routine testing.
Define acceptable ranges and criteria for evaluating QC sample results.
1.4.2 Corrective Actions:
Document procedures for corrective action in case of QC failures.
Outline steps to identify and rectify issues leading to QC failures.
1.5 External Quality Assurance Programs:
1.5.1 Participation:
Specify the laboratory's participation in external proficiency testing programs.
Outline procedures for receiving, handling, and reporting external QC samples.
1.5.2 Corrective Actions:
Document corrective actions in response to external QC discrepancies.
Ensure timely communication with relevant external QA providers.
2. Quality Assurance (QA) Procedures:
2.1 Document Control:
2.1.1 Versioning and Updates:
Establish a system for document control, including versioning and updates.
Outline the approval process for SOPs and other relevant documents.
2.1.2 Archiving:
Document procedures for archiving and retrieving documents.
Define the retention period for different types of documents.
2.2 Training and Competency Assessment:
2.2.1 Training Requirements:
Define training requirements for laboratory personnel.
Document procedures for initial and ongoing competency assessments.
2.2.2 Training Records:
Establish a system for maintaining and documenting training records.
Ensure that all personnel are trained on new or updated procedures.
2.3 Audit and Inspection Procedures:
CEH/LAB/SOPs
2.3.1 Schedule:
Establish a schedule for internal and external audits.
Outline the scope and criteria for audits.
2.3.2 Corrective Actions:
Document procedures for addressing findings from audits and inspections.
Outline corrective and preventive actions.
2.4 Non-Conformance and Corrective Action:
2.4.1 Reporting:
Define procedures for reporting and documenting non-conformance events.
Establish a process for investigating the root cause of non-conformance.
2.4.2 Corrective and Preventive Actions:
Document corrective and preventive actions based on non-conformance investigations.
Ensure implementation of corrective actions to prevent recurrence.
2.5 Continuous Improvement:
2.5.1 Feedback Mechanism:
Implement a system for receiving feedback from laboratory staff.
Encourage staff to provide suggestions for process improvement.
2.5.2 Documentation of Improvements:
Document improvements made based on feedback or continuous improvement initiatives.
Regularly review processes to identify opportunities for enhancement.
3. Reporting and Communication:
3.1 Result Reporting:
3.1.1 Criteria for Reporting:
Establish procedures for result reporting to healthcare providers.
Document criteria for reporting critical or abnormal results.
3.1.2 Communication Channels:
Define the communication channels for reporting results.
Ensure timely and accurate communication with relevant parties.
3.2 Communication of QA/QC Issues:
CEH/LAB/SOPs
3.2.1 Internal Communication:
Outline procedures for internal communication of QA/QC issues.
Document the process for notifying relevant personnel about critical events.
3.2.2 Dissemination of Information:
Establish a system for disseminating information and updates regarding QA/QC issues.
Ensure clear communication channels within the laboratory
CEH/LAB/SOPs
SOP AWARENESS LOG.
I, the under named, have read and understand the contents of this SOP. I agree to contact
my supervisor/ designee if I have any query.
NO. DATE NAME SIGNATURE
CEH/LAB/SOPs
