Ease ISO 17025 Compliance & Facilitate Audit Preparation The - - PowerPoint PPT Presentation

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Ease ISO 17025 Compliance & Facilitate Audit Preparation The - - PowerPoint PPT Presentation

Jul 01, 2023 550 likes •1.07k views

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

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The world leader in serving science

Proprietary & Confidential

Ease ISO 17025 Compliance & Facilitate Audit Preparation

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Ensure data integrity

  • Method validation, measurement

traceability, records and attachments, access levels/groups/roles

How can we facilitate ISO 17025 compliance? Continuous improvement

  • CAPA, complaints, incident

management, SQC/AQC

Confirm capacity to do the work

  • Availability of resources, training and equipment records,

quality supplies and services, instrument management

Client management

  • Requests, contracts, contacts, pricing
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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?
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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

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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
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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
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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
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4.4 Review of Requests and Contracts

Contracts Module – Landing page

Manage all aspects of clients and contracts

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4.4 Review of Requests and Contracts

Contacts

Contacts may be associated with Customers and Suppliers Contact ID may be automatically generated

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4.4 Review of Requests and Contracts

Price management

A cost may be associated with each method, with discounts based around quantities Costs may also be associated with specific test schedules and preparations

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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…
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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…

 

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4.6 Purchasing Services and Supplies

Stocks and Suppliers

Manage suppliers, their stock and their ratings The stock table links back to the supplier and shows their rating

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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

  • ptionally be entered
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4.6 Purchasing Services and Supplies

Stocks and Suppliers

Stock management dashboards enable efficient stock management

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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.

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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
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4.8 Complaints

Incident Management in LIMS

Report tracks all actions leading to incident to help determine any external factors

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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
  • f 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
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4.11 Preventative Action

AQC/SQC charts

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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…
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4.12 Records

Access, Groups & Roles

Strict access controls on login and passwords Roles can be assigned to users & user groups to control access to specific functions

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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.
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4.12 Records

Including attachments in reports

Attachments are available in the Report Designer – and you can add them to your reports

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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
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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.
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5.2.5 Training and authorization of personnel

Training Records

Store course information for all types of training

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5.2.5 Training and authorization of personnel

Training Records

Record for each person complete list of training including expiry dates and grace periods Validation by e-signature Record training required to operate instruments or complete prep/analysis

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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

  • ption is used
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5.4.5 Validation of methods

  • 5.4.5.1 - Validation is the confirmation by examination and the provision
  • f 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.

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5.4.5 Validation of methods

  • Process of ‘validation’
  • Identify the purpose of the test
  • Review method performance data
  • Review the data
  • Confirm ‘fitness for purpose’
  • LIMS AQC Worksheets provide regular confirmation of analytical quality
  • Initialization checks, Calibration checks, interference checks, matrix spike,

matrix spike duplicates, duplicates, controls, surrogates…

  • Can specify ‘patterns’ of standards etc
  • “Run a blank and 5 calibration standards”
  • “Then a check standard after every 10 samples”
  • “Always finish the worksheet with a check standard”
  • Also used for
  • 4.11 Preventive action
  • 5.9 Assuring the Quality of Test Results
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5.4.5 Validation of methods

LIMS AQC Worksheets

Worksheet template contains details of calibration standard patterns, etc. that need to be run

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5.5 Equipment

  • Records shall be maintained of each item of equipment…
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5.5 Equipment

ICMS in LIMS

  • Instrument History
  • Calibration, Maintenance

and Servicing Records

  • Improved Calibration and

Servicing Management

  • Scheduling
  • Reporting
  • Management of

individual instrument parts

  • Instrument status control

and checking

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5.5 Equipment

Instrument Calibration Program

Need to specify frequency patterns

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5.5 Equipment

Instrument Management

Instrument Templates are used to simplify the definition of many instruments of the same type Instruments consist of zero or more parts which are also templated. These may be associated with many different instrument templates

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5.5 Equipment

Instrument Management

Instrument records can be created manually or using a template Instrument parts can then be associated with their instrument – they have a status, and may be moved between instruments

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5.5 Equipment

Instrument Setup

Fixed Parameters can be associated with an instrument reflecting how it is set up Results of Calibration samples can also be stored here automatically Instrument parameters can be used in calculations that make use of this particular instrument

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5.5 Equipment

Instrument History

It is important to know what has happened to an instrument over a period of time. Or more importantly - what was the status of the instrument when a reading took place? Events occur manually or automatically as the instrument and its parts are calibrated and serviced This screen is targeted towards incident investigation or compliance audits

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5.5 Equipment

Correction Factors

Fixed Parameters can be associated with an instrument reflecting how it is set up Results of Calibration samples (i.e. response factors) also stored here automatically Instrument parameters can be used in calculations that make use of this particular instrument

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5.5 Equipment

Measurement Traceability

  • Instrument, Operator and Date are stored against results
  • Gives the exact instrument configuration and state
  • Shows who was operating the instrument
  • Calibration samples linked to instrument
  • Tests linked to calibration data via instrument
  • Failed instrument QC allows determination of affected tests

This completes the circle – so you can determine which instrument was involved with a reading and what state it was at. Can also prove the operator was trained in its use.

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5.9 Assuring the Quality of Test Results

  • Note that the Standard is not prescriptive – it is the responsibility of labs

to plan and review appropriate quality control measures

  • New requirement to ‘record data in such a way that trends are detectable

and, where practicable, apply statistical techniques to the reviewing of results’

  • LIMS SQC, AQC Worksheets…(as for 5.4.5)
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The world leader in serving science

Proprietary & Confidential

Benefits of ISO 17025 compliance

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Benefits to Analysts

  • Speedier recording of results
  • Less counter checking for transcription errors
  • Automation of tedious tasks
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Benefits to Supervisors

  • Less time looking for data
  • Improved sample management
  • Improved use of resources
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Benefits to Management

  • Timely information from data
  • Better decision support
  • Information facilitating lab

management

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LIMS assures 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?
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  • For those with ISO 17025 compliance, how challenging is it for you to

demonstrate and maintain compliance?

  • For those not yet compliant to ISO 17025, would your business benefit

from accreditation?

  • If compliance is not critical, are there elements of the functionalities which

would provide benefits to your lab and business?

Next steps

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Ensure data integrity Achieve Your Lab Potential Continuous improvement Confirm capacity to do the work Client management How can we facilitate ISO 17025 compliance?