1. Purpose:
1.1 This SOP outlines the procedure for the re-analysis of raw materials to ensure the accuracy and reliability of quality control data.
2. Scope:
2.1 This SOP applies to all personnel involved in the quality control department responsible for re-analyzing raw materials.
3. Responsibility:
Purpose:
1.1 This SOP outlines the specific responsibilities of personnel involved in the re-analysis of raw materials to ensure accountability and adherence to quality control standards.
Scope:
2.1 This SOP applies to all individuals engaged in the re-analysis process within the quality control department.
Responsibility Matrix:
3.1 Quality Control Analyst:
3.1.1 Initiates the re-analysis process based on discrepancies, deviations, or suspected issues with the initial analysis.
3.1.2 Documents the reason for re-analysis in the laboratory notebook.
3.1.3 Fills out the re-analysis request form, providing essential details such as batch number, date of initial analysis, and reason for re-analysis.
3.2 Quality Control Supervisor:
3.2.1 Oversees the entire re-analysis procedure, ensuring compliance with the SOP.
3.2.2 Reviews and approves the re-analysis request form.
3.2.3 Monitors the progress of re-analysis activities and intervenes in case of deviations or issues.
3.3 Laboratory Technician:
3.3.1 Retrieves the original raw material sample from the designated storage area.
3.3.2 Ensures proper labeling and documentation of the retrieved sample.
3.3.3 Assists in the calibration and verification of analytical equipment.
3.4 Analytical Chemist:
3.4.1 Performs the re-analysis according to the approved analytical method used in the initial analysis. 3.4.2 Documents all observations, results, and any deviations from the original analysis.
3.4.3 Initiates an investigation if discrepancies are found, following the company’s deviation handling procedure.
3.5 Documentation Officer:
3.5.1 Records the re-analysis results in the laboratory notebook.
3.5.2 Updates the batch record with the re-analysis data.
3.5.3 Completes and files the re-analysis request form.
3.6 Quality Assurance Manager:
3.6.1 Reviews and approves the re-analysis results and documentation.
3.6.2 Ensures that the re-analysis process aligns with regulatory requirements and company standards. 3.6.3 Communicates the final re-analysis results to relevant stakeholders.
Training:
4.1 All personnel involved in the re-analysis process must undergo adequate training on their respective responsibilities outlined in this SOP.
Records and Retention:
5.1 All records related to responsibilities in re-analysis, including forms, notebooks, and reports, should be retained as per the company’s document retention policy.
References:
6.1 Reference any relevant documents, standards, or procedures that support the delineation of responsibilities in this SOP.
Approval:
7.1 This SOP is approved by the Quality Control Supervisor and will be subject to periodic review for updates or improvements.
4. Materials and Equipment:
4.1 Raw material samples 4.2 Analytical equipment (specify equipment) 4.3 Reference standards 4.4 Laboratory notebooks 4.5 Reagents and solvents
5. Procedure:
5.1 Initiation of Re-analysis:
Purpose:
1.1 This SOP delineates the specific steps and guidelines for the initiation of the re-analysis process for raw materials, ensuring a systematic approach to address discrepancies or concerns in the initial analysis.
Scope:
2.1 This SOP is applicable to the Quality Control Analyst responsible for initiating the re-analysis procedure.
Initiation Process:
3.1 Identification of Need for Re-analysis:
3.1.1 Regularly monitor quality control data and identify any discrepancies, deviations, or suspected issues with the initial analysis.
3.1.2 Exercise judgment to determine whether the identified issues warrant re-analysis.
3.2 Documentation in Laboratory Notebook:
3.2.1 Record the identified need for re-analysis in the laboratory notebook.
3.2.2 Include details such as the specific raw material, batch number, date of initial analysis, and the reason for considering re-analysis.
3.3 Filling out Re-analysis Request Form:
3.3.1 Complete the re-analysis request form accurately.
3.3.2 Provide essential information, including the batch number, date of the initial analysis, and a brief description of the reason for re-analysis.
3.4 Review by Quality Control Supervisor:
3.4.1 Submit the laboratory notebook entry and re-analysis request form to the Quality Control Supervisor for review.
3.4.2 The Quality Control Supervisor evaluates the justification for re-analysis and approves or denies the request.
3.5 Approved Re-analysis Request:
3.5.1 If the request is approved, proceed to the next steps of the re-analysis process.
3.5.2 If denied, document the decision and the reason for denial in the laboratory notebook.
Training:
4.1 Ensure that the Quality Control Analyst is adequately trained to identify situations warranting re-analysis and to complete the associated documentation.
Records and Retention:
5.1 Maintain a record of all initiated re-analysis procedures, including the laboratory notebook entry and the re-analysis request form.
5.2 Adhere to the document retention policy for the storage of records.
References:
6.1 Reference any relevant documents, guidelines, or procedures that support the initiation process outlined in this SOP.
Approval:
7.1 This SOP is approved by the Quality Control Supervisor and will undergo periodic review for updates or improvements.
5.2 Sample Retrieval:
Purpose:
1.1 This SOP outlines the systematic steps for retrieving raw material samples during the re-analysis process to ensure accuracy and traceability.
Scope:
2.1 This SOP applies to laboratory technicians responsible for retrieving raw material samples for re-analysis.
Sample Retrieval Process:
3.1 Identifying the Original Raw Material Sample:
3.1.1 Refer to the batch records and documentation to identify the original raw material sample slated for re-analysis.
3.1.2 Cross-verify the information with the details provided in the re-analysis request form.
3.2 Locating the Designated Storage Area:
3.2.1 Access the designated storage area where raw material samples are stored.
3.2.2 Adhere to any specific storage conditions or requirements outlined in the company’s procedures.
3.3 Verification of Sample Labeling:
3.3.1 Confirm that the retrieved sample corresponds to the identified raw material.
3.3.2 Verify the accuracy of the labeling, including batch number, date, and any other relevant information.
3.4 Securing the Sample:
3.4.1 Use appropriate tools and equipment to secure the raw material sample without compromising its integrity.
3.4.2 Follow established protocols for handling and transporting samples to prevent contamination or damage.
3.5 Documentation of Sample Retrieval:
3.5.1 Document the sample retrieval process in the laboratory notebook.
3.5.2 Include details such as the date and time of retrieval, the person performing the retrieval, and any observations related to the sample condition.
Training:
4.1 Ensure that laboratory technicians are adequately trained in the proper procedures for identifying, locating, and retrieving raw material samples.
Records and Retention:
5.1 Maintain a record of all sample retrieval activities, including entries in the laboratory notebook.
5.2 Adhere to the document retention policy for the storage of records.
References:
6.1 Reference any relevant documents, guidelines, or procedures that support the sample retrieval process outlined in this SOP.
Approval:
7.1 This SOP is approved by the Quality Control Supervisor and will undergo periodic review for updates or improvements.
5.3 Preparation of Equipment:
Purpose:
1.1 This SOP delineates the systematic steps for the preparation and calibration of analytical equipment before conducting the re-analysis of raw materials.
Scope:
2.1 This SOP is applicable to laboratory technicians responsible for preparing and calibrating analytical equipment for re-analysis.
Preparation of Equipment Process:
3.1 Reviewing Analytical Method:
3.1.1 Obtain the approved analytical method used in the initial analysis from the laboratory records.
3.1.2 Review the method to understand the specific equipment and calibration requirements.
3.2 Gathering Necessary Materials:
3.2.1 Ensure all required reagents, solvents, and consumables are available and meet specified standards. 3.2.2 Check the expiry dates and conditions of all materials.
3.3 Calibration of Equipment:
3.3.1 Power on and initiate the calibration process for each analytical instrument as per the manufacturer’s guidelines.
3.3.2 Use certified reference standards to calibrate the equipment, following the established calibration protocol.
3.4 Verification of Instrument Performance:
3.4.1 Verify the performance of each instrument by analyzing control samples or reference materials.
3.4.2 Document calibration results and any adjustments made to ensure compliance with accuracy requirements.
3.5 Ensuring Cleanliness:
3.5.1 Clean and verify the cleanliness of all equipment components that come into contact with the raw material samples.
3.5.2 Follow the company’s cleaning procedures to prevent cross-contamination.
3.6 Recording Calibration Details:
3.6.1 Document all calibration activities in the equipment logbook.
3.6.2 Include details such as the date, instrument identification, calibration results, and the name of the technician performing the calibration.
Training:
4.1 Ensure that laboratory technicians are adequately trained in the proper procedures for reviewing analytical methods, gathering materials, and calibrating equipment.
Records and Retention:
5.1 Maintain a record of all equipment preparation and calibration activities in the equipment logbook. 5.2 Adhere to the document retention policy for the storage of records.
References:
6.1 Reference any relevant documents, guidelines, or procedures that support the equipment preparation process outlined in this SOP.
Approval:
7.1 This SOP is approved by the Quality Control Supervisor and will undergo periodic review for updates or improvements.
5.4 Re-analysis:
Purpose:
1.1 This SOP outlines the systematic steps involved in the re-analysis of raw materials to ensure the accuracy, reliability, and traceability of quality control data.
Scope:
2.1 This SOP is applicable to analytical chemists and laboratory personnel responsible for conducting the re-analysis of raw materials.
Re-analysis Process:
3.1 Reference to Initial Analysis:
3.1.1 Obtain and review the results of the initial analysis from the laboratory records.
3.1.2 Understand the specific parameters, methods, and instruments used in the initial analysis.
3.2 Verification of Sample Identity:
3.2.1 Confirm the identity of the raw material sample slated for re-analysis.
3.2.2 Cross-verify the sample information with the details provided in the re-analysis request form.
3.3 Use of Approved Analytical Method:
3.3.1 Utilize the approved analytical method specified in the initial analysis for the re-analysis.
3.3.2 Ensure all equipment is calibrated and in optimal condition before commencing the re-analysis.
3.4 Re-analysis Execution:
3.4.1 Conduct the re-analysis following the established analytical procedure.
3.4.2 Record all observations, results, and any deviations from the initial analysis.
3.5 Investigation of Discrepancies:
3.5.1 If discrepancies are found, initiate an investigation as per the company’s deviation handling procedure.
3.5.2 Document the investigation process, findings, and corrective actions taken.
3.6 Documentation of Re-analysis Results:
3.6.1 Record the re-analysis results in the laboratory notebook.
3.6.2 Include details such as the date and time of re-analysis, instrument used, and the name of the analyst.
3.7 Update of Batch Records:
3.7.1 Update the batch record with the re-analysis data.
3.7.2 Ensure that all relevant information is accurately reflected in the batch record.
3.8 Completion of Re-analysis Request Form:
3.8.1 Complete and file the re-analysis request form, indicating the outcomes of the re-analysis.
3.8.2 Include any additional comments or notes relevant to the re-analysis process.
Training:
4.1 Ensure that analytical chemists and laboratory personnel are adequately trained in the proper procedures for re-analysis.
Records and Retention:
5.1 Maintain records of all re-analysis activities, including entries in the laboratory notebook, updated batch records, and completed re-analysis request forms.
5.2 Adhere to the document retention policy for the storage of records.
References:
6.1 Reference any relevant documents, guidelines, or procedures that support the re-analysis process outlined in this SOP.
Approval:
7.1 This SOP is approved by the Quality Control Supervisor and will undergo periodic review for updates or improvements.
5.5 Documentation:
Purpose:
1.1 This SOP outlines the systematic procedures for documenting various aspects of the re-analysis of raw materials to ensure comprehensive and traceable record-keeping.
Scope:
2.1 This SOP is applicable to documentation officers and personnel responsible for recording and maintaining records during the re-analysis process.
Documentation Process:
3.1 Recording Re-analysis Results:
3.1.1 Transcribe the results of the re-analysis accurately into the laboratory notebook.
3.1.2 Include details such as the date and time of re-analysis, instrument used, and any observations made during the process.
3.2 Updating Batch Records:
3.2.1 Verify the accuracy of the re-analysis results.
3.2.2 Update the batch record with the latest information, ensuring consistency and completeness.
3.3 Completion of Re-analysis Request Form:
3.3.1 Fill out the re-analysis request form with the outcomes of the re-analysis.
3.3.2 Include any additional comments or notes relevant to the re-analysis process.
3.4 Quality Assurance Review:
3.4.1 Submit all documentation related to the re-analysis to the Quality Assurance Manager for review. 3.4.2 The Quality Assurance Manager ensures the accuracy and compliance of the documentation with established standards.
3.5 Communication of Re-analysis Results:
3.5.1 Communicate the final re-analysis results to relevant stakeholders, including the Quality Control Supervisor and other pertinent departments.
3.5.2 Ensure clear and transparent communication to facilitate informed decision-making.
3.6 Archiving of Records:
3.6.1 Archive all documents related to the re-analysis, including laboratory notebooks, updated batch records, and completed re-analysis request forms.
3.6.2 Adhere to the document retention policy for the storage of records.
Training:
4.1 Ensure that documentation officers and relevant personnel are adequately trained in the proper procedures for recording and updating documents during re-analysis.
Records and Retention:
5.1 Maintain records of all documentation activities related to re-analysis.
5.2 Adhere to the document retention policy for the storage of records.
References:
6.1 Reference any relevant documents, guidelines, or procedures that support the documentation process outlined in this SOP.
Approval:
7.1 This SOP is approved by the Quality Assurance Manager and will undergo periodic review for updates or improvements.
5.6 Reporting:
Purpose:
1.1 This SOP outlines the systematic procedures for reporting the results of the re-analysis of raw materials, ensuring accurate communication and transparency.
Scope:
2.1 This SOP is applicable to analytical chemists, laboratory personnel, and individuals responsible for reporting re-analysis results.
Reporting Process:
3.1 Quality Control Analyst’s Responsibility:
3.1.1 The Quality Control Analyst compiles the re-analysis results, ensuring all relevant data is accurately represented.
3.1.2 Verify the alignment of results with the initial analysis and any deviations documented during re-analysis.
3.2 Preparation of a Comprehensive Report:
3.2.1 Draft a comprehensive report summarizing the re-analysis process, methodologies used, and key findings.
3.2.2 Include any observed discrepancies, deviations, or unexpected outcomes in the report.
3.3 Quality Assurance Review:
3.3.1 Submit the re-analysis report to the Quality Assurance Manager for review and approval.
3.3.2 The Quality Assurance Manager ensures the accuracy, completeness, and compliance of the report with established standards.
3.4 Communication to Stakeholders:
3.4.1 Communicate the final re-analysis results to relevant stakeholders, including the Quality Control Supervisor and other pertinent departments.
3.4.2 Clearly convey any potential implications or actions required based on the re-analysis findings.
3.5 Updating Certificate of Analysis (CoA):
3.5.1 If necessary, update the Certificate of Analysis (CoA) with the re-analysis data.
3.5.2 Ensure that the CoA accurately reflects the latest information and is in compliance with regulatory requirements.
3.6 Archiving of Reports:
3.6.1 Archive the final re-analysis report, including any supporting documents or correspondence.
3.6.2 Adhere to the document retention policy for the storage of records.
Training:
4.1 Ensure that personnel responsible for reporting re-analysis results are adequately trained in the preparation of comprehensive reports and communication protocols.
Records and Retention:
5.1 Maintain records of all reporting activities related to re-analysis, including the final report and any updated CoA.
5.2 Adhere to the document retention policy for the storage of records.
References:
6.1 Reference any relevant documents, guidelines, or procedures that support the reporting process outlined in this SOP.
Approval:
7.1 This SOP is approved by the Quality Assurance Manager and will undergo periodic review for updates or improvements.
6. Training:
Purpose:
1.1 This SOP outlines the systematic procedures for reporting the results of the re-analysis of raw materials, ensuring accurate communication and transparency.
Scope:
2.1 This SOP is applicable to analytical chemists, laboratory personnel, and individuals responsible for reporting re-analysis results.
Reporting Process:
3.1 Quality Control Analyst’s Responsibility:
3.1.1 The Quality Control Analyst compiles the re-analysis results, ensuring all relevant data is accurately represented.
3.1.2 Verify the alignment of results with the initial analysis and any deviations documented during re-analysis.
3.2 Preparation of a Comprehensive Report:
3.2.1 Draft a comprehensive report summarizing the re-analysis process, methodologies used, and key findings.
3.2.2 Include any observed discrepancies, deviations, or unexpected outcomes in the report.
3.3 Quality Assurance Review:
3.3.1 Submit the re-analysis report to the Quality Assurance Manager for review and approval.
3.3.2 The Quality Assurance Manager ensures the accuracy, completeness, and compliance of the report with established standards.
3.4 Communication to Stakeholders:
3.4.1 Communicate the final re-analysis results to relevant stakeholders, including the Quality Control Supervisor and other pertinent departments.
3.4.2 Clearly convey any potential implications or actions required based on the re-analysis findings.
3.5 Updating Certificate of Analysis (CoA):
3.5.1 If necessary, update the Certificate of Analysis (CoA) with the re-analysis data.
3.5.2 Ensure that the CoA accurately reflects the latest information and is in compliance with regulatory requirements.
3.6 Archiving of Reports:
3.6.1 Archive the final re-analysis report, including any supporting documents or correspondence.
3.6.2 Adhere to the document retention policy for the storage of records.
Training:
4.1 Ensure that personnel responsible for reporting re-analysis results are adequately trained in the preparation of comprehensive reports and communication protocols.
Records and Retention:
5.1 Maintain records of all reporting activities related to re-analysis, including the final report and any updated CoA.
5.2 Adhere to the document retention policy for the storage of records.
References:
6.1 Reference any relevant documents, guidelines, or procedures that support the reporting process outlined in this SOP.
Approval:
7.1 This SOP is approved by the Quality Assurance Manager and will undergo periodic review for updates or improvements.
7. Records and Retention:
Purpose:
1.1 This SOP outlines the procedures for the systematic recording and retention of documents related to the re-analysis of raw materials, ensuring compliance with regulatory requirements and facilitating traceability.
Scope:
2.1 This SOP is applicable to all personnel involved in the re-analysis process, including Quality Control Analysts, Laboratory Technicians, and Documentation Officers.
Recordkeeping Procedures:
3.1 Laboratory Notebook Entries:
3.1.1 All personnel involved in re-analysis must maintain a detailed and accurate laboratory notebook. 3.1.2 Record entries for each step of the re-analysis process, including sample retrieval, equipment preparation, and documentation of results.
3.2 Batch Records:
3.2.1 Update batch records promptly with re-analysis data.
3.2.2 Include information such as the date and time of re-analysis, instrument used, and any deviations observed.
3.3 Re-analysis Request Forms:
3.3.1 Complete and file re-analysis request forms for each instance of re-analysis.
3.3.2 Include batch number, date of initial analysis, and the reason for re-analysis.
3.4 Reports and Communication Records:
3.4.1 Maintain copies of comprehensive re-analysis reports.
3.4.2 Keep records of communications related to re-analysis results, including emails, meeting minutes, or any other written correspondence.
Retention Periods:
4.1 Laboratory Notebooks:
4.1.1 Retain laboratory notebooks for a minimum of [Specify Duration, e.g., 5 years] after the completion of the re-analysis.
4.1.2 Ensure secure storage to prevent loss, damage, or unauthorized access.
4.2 Batch Records:
4.2.1 Retain batch records for a minimum of [Specify Duration, e.g., 5 years] after the product’s expiration date.
4.2.2 Store batch records in a controlled environment to prevent deterioration.
4.3 Re-analysis Request Forms:
4.3.1 Retain re-analysis request forms for a minimum of [Specify Duration, e.g., 5 years] from the date of completion.
4.3.2 Ensure accessibility for audits or inspections.
4.4 Reports and Communication Records:
4.4.1 Retain re-analysis reports and communication records for a minimum of [Specify Duration, e.g., 5 years]. 4.4.2 Organize records for easy retrieval during inspections or audits.
Document Destruction:
5.1 Confidential Information:
5.1.1 Shred or destroy documents containing confidential information, such as employee records or proprietary data, following company policies.
5.1.2 Ensure compliance with data protection and privacy regulations.
5.2 End of Retention Period:
5.2.1 Establish a protocol for the systematic destruction of records at the end of the designated retention period.
5.2.2 Document the destruction process, including the method used and the date of destruction.
References:
6.1 Reference any relevant regulatory requirements, industry standards, or internal procedures guiding recordkeeping and retention.
Approval:
7.1 This SOP is approved by the Quality Assurance Manager and will undergo periodic review for updates or improvements.
8. References:
8.1 Reference any relevant documents, standards, or procedures that support this SOP.
9. Approval:
9.1 This SOP is approved by the Quality Control Supervisor and will be reviewed periodically for updates or improvements.
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