Ease ISO 17025 Compliance & Facilitate Audit Preparation The world leader in serving science Proprietary & Confidential
How can we facilitate ISO 17025 compliance? Confirm capacity to do the work • Availability of resources, training and equipment records, quality supplies and services, instrument management Ensure data integrity Continuous improvement • Method validation, measurement • CAPA, complaints, incident traceability, records and attachments, management, SQC/AQC access levels/groups/roles Client management • Requests, contracts, contacts, pricing 2 Proprietary & Confidential
How do you assure the quality of your results? • Example • Your lab reports a pH result of 8.9 on a sample • Was the pH meter calibrated? • Where is the record of the calibration? • Who calibrated the pH meter? • Were they trained to calibrate the pH meter? • Did they follow the correct calibration SOP? • What buffer solution did they use? • Was the buffer solution within its shelf life? • Was the buffer solution provided by a reputable supplier? • Did the QC results drift since the last calibration? • Was the sample stored properly? • Was the sample prepared properly? 3 Proprietary & Confidential
Structure of ISO 17025 • Two main sections applicable to LIMS • Section 4 – Management Requirements • Document Control, Supplier management, Review of Requests, Tenders and Contracts, Corrective actions, Records • Section 5 – Technical Requirements • Qualification of operators, instruments, methods, Control of data, Reporting 4 Proprietary & Confidential
Requirements of ISO 17025 • Requirements which will be most involved with LIMS are in sections: • 4.4 Review of requests and contracts • 4.6 Purchasing services and supplies • 4.8 Complaints • 4.9 Control of non-conforming testing • 4.10 Corrective action • 4.11 Preventive action • 4.12 Records 5 Proprietary & Confidential
Requirements of ISO 17025 • Requirements which will be most involved with LIMS are in sections: • 5.2.5 Training and authorization of personnel • 5.4.5 Validation of methods • 5.5 Equipment • 5.9 Assuring the quality of test results • 5.10 Reporting results 6 Proprietary & Confidential
4.4 Review of Requests and Contracts • The aim is to ensure mutual understanding, between laboratory and client, at all stages of the work regarding: • Client requirements, including when results are required • The tests to be performed • Performance characteristics • Keep records of relevant discussions with clients as attachments • See also 4.12 - Records 7 Proprietary & Confidential
4.4 Review of Requests and Contracts Contracts Module – Landing page Manage all aspects of clients and contracts 8 Proprietary & Confidential
4.4 Review of Requests and Contracts Contacts Contacts may be associated with Customers and Suppliers Contact ID may be automatically generated 9 Proprietary & Confidential
4.4 Review of Requests and Contracts Price management A cost may be associated with each method, with discounts based around Costs may also be quantities associated with specific test schedules and preparations 10 Proprietary & Confidential
4.4 Review of Requests and Contracts Do we have capacity to do the work? “4.4.1 b) the laboratory has the capability and resources to meet the requirements” • Operator Loading Report… 11 Proprietary & Confidential
4.6 Purchasing Services and Supplies “The laboratory shall use only such services and supplies that are of the quality needed to sustain confidence in the results of tests and/or calibrations” • Track approved suppliers • LIMS stock control for standards, reagents etc… 12 Proprietary & Confidential
4.6 Purchasing Services and Supplies Stocks and Suppliers Manage suppliers, The stock table links back their stock and their to the supplier and shows ratings their rating 13 Proprietary & Confidential
4.6 Purchasing Services and Supplies Stocks and Suppliers Inventory requirements are held against the Analysis Inventory is decremented at result entry, and additional information can optionally be entered 14 Proprietary & Confidential
4.6 Purchasing Services and Supplies Stocks and Suppliers Stock management dashboards enable efficient stock management 15 Proprietary & Confidential
4.6 Purchasing Services and Supplies Software suppliers • Don’t forget the LIMS and other critical software! • ISO 9000-3 is the specific application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software • Ensure your software supplier follows these guidelines • If in doubt, be sure to check the software supplier scope statement • Thermo Fisher Scientific follows a Quality Management System which complies with 9001:2008 for the design, development, sales, implementation and support of its software. 16 Proprietary & Confidential
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4.8 Complaints • When something unexpected happens, we need to plan and track actions through to closure • LIMS ‘Incident Management’ • Generated manually or automatically • Templates for ‘type of incident’ – defines required actions • Each action completed, reviewed and closed • Report of all actions to close an incident • Also used for • 4.9 Control of non-conforming testing • 4.10 Corrective action (fixing the issue and avoiding recurrence) • Enables Continuous Improvement for the laboratory 18 Proprietary & Confidential
4.8 Complaints Incident Management in LIMS Report tracks all actions leading to incident to help determine any external factors 19 Proprietary & Confidential
4.11 Preventative Action • 4.11.1 potential sources of non conformances…shall be identified… • LIMS SQC/AQC Charts • Control charts can identify results that indicate analytical process ‘heading out of control’, even though results today still ‘in spec’ • AQC Worksheets specifically check the analytical method See 5.4.5 and 5.9 • Also used for • 5.4.5 Method Validation • 5.9 Assuring the Quality of Test Results 20 Proprietary & Confidential
4.11 Preventative Action AQC/SQC charts 21 Proprietary & Confidential
4.12 Records • Keep general and technical records. • Prevent unauthorized access • Who can do what? • Audit trails • Who actually did what and when • LIMS Security controls… 22 Proprietary & Confidential
4.12 Records Access, Groups & Roles Roles can be assigned to Strict access controls on users & user groups to login and passwords control access to specific functions 23 Proprietary & Confidential
4.12 Records Different attachment types • Files • Uploaded and stored on the server • Notes • Simple free text fields against any entity • Links • To external files or URLs. 24 Proprietary & Confidential
4.12 Records Including attachments in reports Attachments are available in the Report Designer – and you can add them to your reports 25 Proprietary & Confidential
Requirements of ISO 17025 • Requirements which will be most involved with LIMS are in sections: • 5.2.5 Training and authorization of personnel • 5.4.5 Validation of methods • 5.5 Equipment • 5.9 Assuring the quality of test results • 5.10 Reporting results 26 Proprietary & Confidential
5.2.5 Training and authorization of personnel • 5.2.5 The management shall authorize specific personnel… • ‘Operator Approval’ controls access to instruments and methods. 27 Proprietary & Confidential
5.2.5 Training and authorization of personnel Training Records Store course information for all types of training 28 Proprietary & Confidential
5.2.5 Training and authorization of personnel Training Records Record training required to operate instruments or complete prep/analysis Record for each person complete list of training Validation by e-signature including expiry dates and grace periods 29 Proprietary & Confidential
5.2.5 Training and authorization of personnel Training Records Privilege control allows certain users to override training records for exceptional circumstances A mandatory comment is enforced when the override option is used 30 Proprietary & Confidential
5.4.5 Validation of methods • 5.4.5.1 - Validation is the confirmation by examination and the provision of objective evidence that the particular requirements of a specific intended use are fulfilled. • OR… • Does the method provide analysts the ability to report results accurately, precisely and with confidence? • The primary responsibility to decide on ‘fitness for purpose’ lies with the lab. 31 Proprietary & Confidential
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