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Department of Safety and Risk Services (SRS) 1 University of New Mexico Albuquerque, NM 87131 HTTP://SRS.UNM.edu Self Audit for Laboratories This self audit form has been developed to integrate laboratory

How to fill out self audit for laboratories

How to fill out self audit for laboratories?

1. Identify the purpose of the self audit: Before beginning the self audit, it is important to understand the purpose behind conducting it. Is it to ensure compliance with regulatory standards, improve operational efficiency, or identify areas for improvement? Clearly define the objectives before proceeding.
2. Gather the necessary documentation: Collect all relevant documents such as laboratory procedures, quality control records, calibration certificates, and safety protocols. These documents will serve as references during the self audit.
3. Review regulatory requirements: Familiarize yourself with the applicable regulations for laboratory operations. This may include guidelines from organizations such as the International Organization for Standardization (ISO) or specific industry standards. Ensure that the self audit criteria align with these requirements.
4. Conduct an inventory assessment: Begin the self audit by assessing the laboratory's inventory. Review the stock of chemicals, reagents, and test materials to ensure proper storage, labeling, and disposal protocols are being followed. Check if there are any expired items that need to be discarded.
5. Evaluate equipment and instruments: Inspect all laboratory equipment and instruments for functionality and calibration. Ensure that maintenance records are up to date and that preventive maintenance activities are being performed regularly. Address any equipment deficiencies or issues discovered during the audit.
6. Assess quality control procedures: Review the laboratory's quality control procedures to ensure they are being followed accurately. This includes verifying that appropriate samples are being used, controls are in place, and records of analysis results are properly documented.
7. Review data management and recordkeeping: Evaluate the laboratory's data management and recordkeeping practices to ensure accuracy, traceability, and security. Ensure that all data and records are appropriately stored, backed up, and accessible when needed.
8. Evaluate staff competence and training: Assess the competence and training of laboratory personnel. Confirm that all staff members are properly trained for their respective roles and that ongoing training programs are in place.
9. Perform a safety assessment: Review the laboratory's safety protocols, including emergency procedures, hazard communication, personal protective equipment usage, and waste disposal practices. Identify any areas for improvement and address them promptly.

Who needs self audit for laboratories?

1. Laboratories seeking accreditation: Laboratories that aim to obtain or maintain accreditation may need to conduct self audits regularly. Accreditation bodies often require laboratories to demonstrate compliance with specific standards, and a self audit can help identify areas where improvement is needed.
2. Laboratories subject to regulatory inspections: Laboratories that are subject to regulatory inspections may benefit from conducting self audits to ensure compliance with applicable regulations. By identifying and addressing potential non-compliance issues in advance, laboratories can avoid penalties or disruptions to their operations.
3. Laboratories focused on continuous improvement: Even laboratories that are not specifically required to conduct self audits can benefit from doing so. Self audits provide insights into operational efficiency, quality management, and safety practices. They help identify areas for improvement and contribute to the overall continuous improvement culture within the laboratory.

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What is self audit for laboratories?

Self audit for laboratories is a process in which a laboratory evaluates its own processes, procedures, and performance to ensure compliance with regulations, standards, and best practices.

Who is required to file self audit for laboratories?

Laboratories, including medical, research, or testing laboratories, are typically required to conduct and file self audits.

How to fill out self audit for laboratories?

Self audits for laboratories are typically filled out by designated personnel within the laboratory who are familiar with the processes and procedures being audited.

What is the purpose of self audit for laboratories?

The purpose of self audit for laboratories is to ensure quality control, regulatory compliance, and continuous improvement in laboratory processes and procedures.

What information must be reported on self audit for laboratories?

Information reported on self audits for laboratories may include details on equipment maintenance, staff training, data management, quality control measures, and any non-conformities found during the audit.