Quality Flashcards
What is an ISO?
International Organisation for Standardisation
* degree to which a set of inherent characteristics of an object, fulfils requirements
Who are the stakeholders whose needs must be met in forensic science?
- law enforncement
- defence
- justice
- regulator
- society
What is a standard?
- a document
- established by consensus
- approved by a recognised body
- that provides for common and repeated use, rules, guidance or characteristics for activies or their results
- aimed at achieving the optimum degree of order in a given context
What are the current standards framework in examination and writing?
- ISO 17025 accreditation (or 17020)
- criminal procedure rules
- rules of evidence - admissibility and relevance
- common-law
- professional codes - professional bodies (CSOFS) and regulatory bodies (FSR)
What are the three things that standards provide for quality in forensic science?
- scientific
- legal
- ethical
How do the standards provide scientific quality?
- scientific method - peer review, test, theory, observation
- objectivity - unbiased, impartial
- logic and rationality
How do the standards provide legal quality?
- common law
- rules of evidence - admissibility and relevance
- procedural rules
How do the standards provide ethical quality?
- professional codes - professional bodies, forensic science regulator
- moral principles - same as above
What are the five requirements in the CPS guidance?
- to comply with the Codes of Coducts and Practice by independent Forensic Science Regulator
- Quality Standards and Assurance processes are applied consistently and comply with appropriate ISO stands, UKAS, EU directives
- clear communication and interpretation of scientific processes, procedures, strengths, weaknesses and meaning
- engage with FSR process associated with proportionate prosecution requirements
- to be fully aware of and complient with CPIA Disclosure and Expert Witness obligations
Why are the quality standards important?
- there may be a greater risk that those guilt of crime may escape justice
- innocent people could be convicted
Case of Adam Scott
- DNA contamination error that was avoidable
- lack of records meant it was impossible to work out who made the mistake
- shows why quality matters
Method of analysis
- 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
What are the reasons for an error to do with the method and analyst?
- method is reliable but analyst is not qualified
- method is reliable, analyst qualified but method not properly applied
- analyst is qualified but method is unreliable
- analyst not qualified and method not reliable
What makes a method unreliable?
- inconsistent or non-existent criteria for conclusions
- not rooted in a scientific process
- does not account of uncertainty
- old methods - need to be modified based on new info
What is root cause analysis?
systematic process used to identify the underlying causes or factors that contributed to a particular forensic incident or outcome
* aims to uncover the reasons why an event occurred
What caused the quality assurance system to be strengthened in 1978?
- John Preece - convicted of rape and murder in 1973 based on blood match and fibres
- Dr Clift reported some results which were clearly wrong and reported results selectively
What is ISO 17025?
Calibration testing
* first used in 1999 by the ISO and IEC (International Electro-technical Commission)
* competent organisation
* competent personnel
* valid methods
* impartiality
Laboratories that have ISO 17025 have demonstrated what?
- they are technically competent
- able to produce precise and accurate test and/or calibration data
What are the two main parts of the ISO 17025?
- management requirements
- technical requirements
What does the management requirements part of ISO 17025 mean?
Primarily related to the operational effectiveness of the quality management system within the laboratory
* management systems & documentations
* control of records
* action to address risks and opportunities
* corrective actions
* interal audits
* management review
What does the technical requirements part of ISO 17025 mean?
Factors which determine the correctness and reliability of tests calibrations
* technical records
* tests or calibration items
* evaluation of measurment and uncertainty
* ensuring validity of results
* reporting opinions and interpretations
* amendments to reports
* complaints
* nonconforming work
What are the five elements of accreditation standard?
- scope
- normative references
- terms and definitions
- managment requirements
- technical requirements
What does scope mean in standards?
- to what extend do your lab activities extend
- if a lab intends to extend its scope, a new audit will be required
What does normative references mean?
Rules that are prescribed by:
* customers
* regulations
* normative documents - ISO/IEC Guide 99 (basic and general concepts and associated terms), ISO/IEC 17000 (vocab and general principles)