Topic 5 - Quality Standards
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What is ISO?
Degree to which a set of inherent characteristics of an object, fulfils requirements
Inherent characteristics
permanent distinguishing features of Forensic science.
Object
scientific evidence/information
Requirements
primarily those of law-enforcement and justice to produce a fair process and safe decision or verdict.
What is a standard?
A document established by consensus approved by a recognized body that provides for common and repeated use, rules, guidance or characteristics for activities or their results aimed at achieving the optimum degree of order in a given context.
Objectivity standards
• Unbiased • Impartial
Scientific standards
• Scientific method • Objectivity • Logic and rationality
comply, ensure, provide, engage, fully CPS Guidance - The core foundation principles for forensic science providers Scientific processes
• To comply with the Codes of Conduct and Practice set down by the independent Forensic Science Regulator. • To ensure Quality Standards and Assurance processes are applied which are nationally consistent and compliant with appropriate ISO standards, United Kingdom Accreditation Service (UKAS) accreditation, EU directives • To provide clear communication and interpretation of scientific processes, procedures, strengths, weaknesses and meaning. • To engage with Streamlined Forensic Reporting (SFR) process associated with proportionate prosecution requirements. • To be fully aware of and compliant with CPIA Disclosure and Expert Witness obligations
What is the importance of quality standards?
• Quality standards in forensic science are integral to the criminal justice system (CJS) • There may be a greater risks that those guilty of crime may escape justice • Or that innocent people could be convicted
Adam Scott Plastic tray
• Innocent man spent five months in jail falsely accused of rape following DNA error • Adam Scott arrested after a plastic tray containing a sample of his saliva was reused by a forensics science provider. • His saliva was wrongly linked to a violent attack on a woman in Manchester carried out when he was hundreds of miles away in Plymouth • The Forensic Science Regulator found he was the victim of avoidable contamination • The Regulator said that the lack of records meant it was impossible to work out who the laboratory technician was behind the mistake Scott had been arrested after a street fight and the saliva sample was taken and held on NDNAD
The method of analysis
• A method is no good, even if it is rooted in the broader scientific method, unless it is constantly applied in the same way every time it was used. • Individuals who have no established approach or who do not use the same approach for each case are not following a reliable process
Reasons for an error
• Method is reliable but the analyst was not qualified. • Method is reliable, analyst is qualified but mothod was not apllied properly. • Analyst is qualified but the method is not reliable. • Analyst is not qualified and method is not reliable.
What makes a method unreliable?
• Inconsistent ot non-existent criteria for conclusions • Not rooted in a scientifc process • Doe not account for uncertainty • Methods previously considered reliable will often need to be modified based upon new information.
ISO 17025
• First used in 1999 • It is the single most important standard for calibration testing laboratories around the world • Laboratories that have been accredited to this international standard have demonstrated that: • They are technically competent and able to produce precise and accurate test and/or calibration data.
Two sections of the ISO17025
• Management requirements - Primarily related to the operational effectiveness of the quality management system within the laboratory • Technical requirements - Factors which determine the correctness and reliability of tests calibrations
The ISO 17025 elements
The ISO 17025 standard itself comprises of five elements: 1. Scope 2. Normative references 3. Terms and defintions 4. Technical requirements
Scope ISO 17025
• To what extent do our laboratory activities extend? • If the laboratory intends to extend its scope then, new audit will be required which is expensive. • you have to stay within the scope of what you’re accredited to
Normative references ISO 17025
Rules prescribed by: * Customers * Regulations * Normative documents * ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms * ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
What does ISO stand for?
International organisation for Standardisation
Terms and definitions ISO 17025
• Essentially a standardised vocabulary (are we speaking the same language) • ISO and IEC maintain terminological databases for use in standardisation
Management requirements ISO 17025
• Management systems & documentation • Control of records • Action to address risks and opportunities • Corrective actions • Internal audits • Management reviews
Technical requirements ISO 17025
• Handling of test or calibration items • Technical records • Evaluation of measurement and certainty • Ensuring validity of results • Reporting opinions and interpretations
What is accreditation?
• Accreditation is a voluntary, formal review process by which an organization or institution is recognized as meeting specific standards or criteria set by an accrediting body. • Forensic suppliers must be accredited to a specific standard • As part of accreditation, laboratories quality management system is thoroughly evaluated on a regular basis to ensure continued technical competence and compliance with ISO/IEC 17025