ISO/IEC 17025:2017 Clause 5.6
Clause 5.6
Ensuring the accuracy and reliability
of food testing results is crucial in laboratories, and ISO/IEC 17025 provides
guidelines for achieving competence in testing. One key aspect of ISO 17025
compliance involves assigning specific personnel the authority and resources
needed to carry out their duties effectively for the following:-
1. Implementation, Maintenance, and
Improvement of the Management System:
In a testing laboratory, this
requirement emphasizes the need for dedicated personnel who have the authority
and resources to effectively manage the laboratory's quality management system
(QMS). The QMS is a set of policies, processes, and procedures put in place to ensure
the laboratory's operations meet the required standards for accuracy,
reliability, and consistency in testing.
ISO 17025 requires the lab to appoint a
Quality Manager. This person has the power to make decisions about quality
matters and is equipped with the necessary resources. Their role involves
establishing procedures for how samples are handled, testing methods are
conducted, and results are reported. Essentially, they ensure the lab's
practices align with ISO 17025 standards.
The point "identification of
deviations from the management system or from the procedures for performing
laboratory activities" in the context of ISO/IEC 17025 refers to the
process of recognizing instances where actual practices deviate from the
established management system or the specific procedures outlined for
laboratory activities.
2. Identification of deviations from
the management system or from the procedures for performing laboratory
activities;
· Management System Deviations: The "management system" in this context refers to the set of policies, processes, and procedures that a laboratory has put in place to ensure the quality and reliability of its testing activities. Deviations from the management system could include instances where the laboratory fails to follow established protocols, doesn't adhere to quality assurance procedures, or experiences disruptions in the overall system designed to maintain quality standards.
· Deviations from Laboratory Procedures: Laboratories have specific procedures in place for each aspect of their activities, such as sample handling, testing methods, and result reporting. Deviations from these procedures occur when there are discrepancies or variations in how tasks are actually carried out compared to the documented, approved procedures. This could be due to human error, equipment malfunctions, or other unforeseen circumstances.
· Identification of Deviation: The laboratory personnel, during regular checks or through an audit, identify that the calibration process for the instrument deviated from the established procedure.
3. Initiation of actions to prevent or
minimize such deviations
· The
"initiation of actions to prevent or minimize such deviations" in the
context of ISO/IEC 17025 involves taking proactive measures to either prevent
or minimize the occurrence of deviations from established procedures or the
laboratory's management system. This preventive approach is crucial for
maintaining the integrity, reliability, and consistency of laboratory
activities. Here's an exploration of how this process works:
· Risk Assessment: Before deviations occur, laboratories often conduct risk assessments to identify potential areas where deviations might occur. This involves evaluating the different steps involved in testing processes, recognizing potential risks, and understanding the impact of these risks on the accuracy and reliability of results.
· Establishing Controls and Procedures: Once potential risks are identified, the laboratory can establish controls and procedures to mitigate these risks. This involves putting measures in place to ensure that deviations are less likely to happen. Controls may include specific training programs for personnel, routine equipment maintenance schedules, and stringent adherence to documented procedures.
· Continuous Monitoring and Auditing: Laboratories must continuously monitor their operations to detect early signs of deviations. This monitoring process may involve regular internal audits, quality control checks, and ongoing assessments of equipment and procedures. By doing so, deviations can be identified in their early stages or even before they occur.
· Training and Competency Development: Personnel involved in laboratory activities should be well-trained and competent in following established procedures. Continuous training programs ensure that laboratory staff are aware of the correct procedures, potential risks, and the importance of strict adherence to protocols. This helps prevent deviations arising from human error or lack of awareness.
· Implementing Corrective and Preventive Actions: In the event that a deviation does occur or is identified through monitoring, the laboratory personnel with the authority and resources initiate corrective actions. Corrective actions address the immediate issue and aim to prevent its recurrence. Simultaneously, preventive actions are taken to address the root cause and minimize the likelihood of similar deviations in the future.
4. Reporting to laboratory
management on the performance of the management system and any need for
improvement;
The requirement "reporting to
laboratory management on the performance of the management system and any need
for improvement" in the context of ISO/IEC 17025 emphasizes the importance
of maintaining open communication channels within a laboratory. This involves
regularly informing management about how well the established management system
is working and identifying areas where improvements may be needed.
Reporting on Management System
Performance:
· Regular Reporting: The laboratory, in accordance with ISO/IEC 17025, establishes a routine reporting mechanism. This could be a monthly or quarterly report that comprehensively outlines the performance of the management system.
· Key Performance Indicators (KPIs): The laboratory identifies key performance indicators (KPIs) related to the management system. These KPIs may include metrics such as the number of completed tests, adherence to turnaround times, and the frequency of quality control failures.
· Analysis of Results: The designated personnel responsible for reporting (which could include the Quality Manager or another appointed authority) analyze the results against the established KPIs. This analysis provides insights into how well the laboratory is meeting its objectives and maintaining compliance with ISO/IEC 17025.
· Identification of Strengths and Weaknesses: The report not only highlights achievements and successes but also identifies areas where the management system is performing below expectations or where there may be room for improvement.
Identifying the Need for Improvement:
· Deviations and Non-Conformities: The report includes information about any deviations or non-conformities that occurred during the reporting period. These could be instances where procedures were not followed, equipment malfunctions, or other issues affecting the quality of results.
· Trends and Analysis: Trends and patterns are identified. For example, if there is a recurring issue with a specific type of test, the report draws attention to this trend and suggests a need for targeted improvement in that area.
· Feedback from Personnel: Input from laboratory personnel is considered. Employees on the ground who are actively involved in testing processes may provide valuable insights into challenges they face, potential bottlenecks, or opportunities for streamlining procedures.
· Recommendations for Improvement: The report concludes with recommendations for improvement. These recommendations may include adjustments to procedures, additional training for personnel, updates to equipment, or other measures aimed at enhancing the overall effectiveness of the management system.
Communication with Laboratory
Management:
· Presentation of Report: The designated personnel present the report to laboratory management. This could be in the form of a meeting, a written report, or a combination of both.
· Discussion and Decision-Making: A discussion ensues between the reporting personnel and laboratory management. Management considers the findings, asks questions, and participates in decision-making regarding the proposed improvements.
· Action Plan: Based on the discussions, an action plan is formulated. This plan outlines the specific steps that will be taken to address identified areas for improvement.
·
5. Ensuring the Effectiveness of
Laboratory Activities:
Ensuring the effectiveness of laboratory
activities is a fundamental aspect of maintaining the quality and reliability
of testing processes. This requirement, often emphasized in standards like
ISO/IEC 17025, underscores the need for laboratories to actively monitor,
assess, and enhance their operations to meet established standards and deliver
accurate results. Here's an exploration of how laboratories ensure the
effectiveness of their activities:
· Robust Quality Management System (QMS): Establishing a robust Quality Management System is foundational. This system includes documented policies, procedures, and processes that guide laboratory activities. It outlines the standards to be met, roles and responsibilities, and the steps to be followed for testing.
· Competent Personnel: Ensuring that laboratory personnel are competent and well-trained is crucial. Competency involves having the necessary skills, knowledge, and experience to perform tasks accurately. Training programs and continuous professional development contribute to maintaining and improving personnel competence.
· Method Validation: Validating testing methods ensures their reliability and accuracy. Validation procedures helps eliminate variations and ensures consistency across different processes. This is particularly important for laboratories that handle diverse types of samples and tests.
· Equipment Calibration and Maintenance: Regular calibration and maintenance of laboratory equipment are essential for accuracy. Deviations in equipment performance can lead to inaccurate results. Calibration involves adjusting instruments to a known standard, ensuring the reliability of measurements.
· Sampling Protocols: Strict adherence to established sampling protocols is crucial. The manner in which samples are collected can significantly impact the reliability of test results. Proper sampling procedures prevent contamination and ensure that the sample is representative of the entire batch.
· Data Integrity and Record Keeping: Maintaining data integrity is critical for the reliability of laboratory results. Accurate record-keeping ensures traceability, allowing the laboratory to track and verify each step of the testing process. This is essential for audits and investigations into any discrepancies.
· Internal Audits and Continuous Monitoring: Internal audits are conducted regularly to assess the laboratory's adherence to established procedures and standards. Continuous monitoring of processes allows for early detection of issues, enabling corrective actions to be taken promptly.
· Participation in Proficiency Testing: Engaging in proficiency testing programs helps laboratories assess their performance against other laboratories. Participation in such programs provides an external benchmark and identifies areas for improvement.
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