Meeting the needs and expectations of your customer. In a forensic lab this means results should be valid, accurate and precise, reproducible, free from errors and able to withstand legal scruting

Quality control

Bad reputation

wrongful convictions

low staff morale

waste of resources

loss/suspension of accreditation

incorrect results

costly to fix

evidence may be thrown out in court

Outcome of an organisation meeting obligations of 

local, state, federal, international reuirements

Enquiry

Pre-assessment

Lab application

Document review: review documents, procedures and schedules

Assessment: 3rd prty audit, assesses compliance, non-conformances are identified

Accreditation: NATA

3 year cycle

Team briefing

Opening meeting

Evaluation of technical competence and exmination of parts of the quality standards

Final team meeting

Closing meeting

Attract cotnracts

Benchmark for performance

Marketing advantage

External recognition of technical competence

Percieved requirement for court reporting

Assists lab in controllign risks and achieving continuous improvement

Observations: recommendations for imporvement

Minor conditions: not related to reliabilty of result, however is related to other areas of the facility, such as labellig or record keeping. Random or infrequent

Condition: directly related to the reliabilty of a result. Potentially compromises result. Systematic issue. Could have been a previous minor condition. Must be addressed and evidence must be presented prio to accreditation being granted/continued

Accreditation granted (routine surveillance every 18 months)

Accreditation suspended (voluntary or imposed)

Accreditation cancelled (rare)

International Organisation for Standardisation

Not an accreditation body

Internatinal standard-settign body composed of representatives from variou national standards organizations

Mandatory component

Shall or must

Not mandatory, strongly recommended

Should

Assist to explain intent of clause

May or might

Quality policy

Quality manual

Procedure

Method

Job descriptions

Form

Records

Corrective and preventative action plan

Corrective action: Reomve causes of nonconformity. Lab must have procedures in place that will help investigate and identify the problem, monitor and follow up to ensure effictiveness, and record keeping

Preventative action: Idenitfy opportunities for improvement. FAD encourages systems where all staff contribute to improvement of lab's management system

Inspections that are designed to verify the lab is compliant with own procedures and ISO standards. Measures effectiveness of quality systems.

Used to identfy training and resources needed.

12 month schedule that covers all management and technical elements of IS17025

Internal auditor: independent qualified personnel who gathers objective evidence to make judgement abotu quality of lab.

Evidence must be valid, authentic, current, sufficient.

Horizontal: one aspect of quality ystem in detail across whole laboratory

Vertical: examine entire process from inputs to outputs

WitnesS: to check is lab is compliant with own process

Evaluate suitability and effectiveness of lab's wuality management system and introduce improvements.

Must include the following:

Suitability of policies

Reports
Audit findings
CAPA's
Proficiency tests
Changes in type of work

customer feedback

recommendations for improvement

other relevant facotors

KPIs

Quality policy 

Must be qualified on basis of education, training, experience, and/or demonstrated skills.

Lab must ID training needs and formulate goals.

Training must be documented

Additional FAD requirements: forensic experience

Ensures high level of competency of staff and thus results with higher integrity and valur

Space, power, lighting, security

Mustn't invalidate results 

Separation of office and examination areas. Logical design.

Limited access

Storage

chain of custody

contamination mitigation measures

transport

protection

tamper proof

Crime scene: 

PPE

Disposabe instruments

Avoid touching/transferring

Follow operating procedures

Lab:

Prevent contamination between exhibits

Environmental monitoring

Substrate controls

Cleaning protocols

Exhibit to exhibit

Exhibit to person

Person to sample

May compromise investigation

Reputation of lab/police/investigators

Lab procedures ensure reference and case samples are processed separately throughout collection, examination, sampling and testing.

If contamination occurs, there is higher degree of certainty that it did not occur in the lab, and can be conveyed in court

Secure overnight/long term

Restricted access

In order to:

prevent loss/degradation of DNA samples

mitigate contamination and security concerns

some must be refrigerated or dried

Standard methods: published by international or national standards writing bodies (Standards australia or ISO)

Published methods: developed by individual scientists, engineers, or ocmmercial companies. Peer reviewed

In-house/lab developed: developed by the lab itself to suit its own particular needs

Uncertainty of results: dispersion of values being attributed to the quantity intending to be measured

Detection limit:  smalest amount that can reliably be detected

Selectivity of method: accuracy in presence of interferences

Linearity 

Limit of repeatability: Identical items by same operator obtainign the same result

Reproducibility: variable conditions but still obtain the same result

Robustness: degree unaffected by minor changes in conditions

Cross sensitivity against matrix: endogenous interferences 

Inteded use

Customer needs

Sensitivity: Rate of change with change in concentration

Accuracy: how close results are to true value

Range

ensures tests are working correctly

detect defective results

prevents from ruining other cases

Quality control: negative and positive controls, artefact checks, peer review interpretation of results

Case record review: 

Tech - interpretations and conclusions are reasonable

Admin - completeness and correctness of records

Proficiency testing: Used to confirm lab's ability to produce technicall correct and valid results, technical competence of the examiner, and benchmark performance against other labs

External: annually by an external provider. Blind tests are sent away to be examined and compared to other labs

Internal: items and tests to be examined are up to the staff, as well as time frame

Court testimony monitoring: objective, appearance, poise, performance, effectiveness.

Observation of testimony, testimony evaluation form, telephonic solicitation 

Process of comparing an instrument's output with a known. Generally performed by an external accredited provider. 

Used to calibrate and check equipment and instruments. Demonstrate's traceability.

Not consumed during calibration.

Physical artefact

Calibration measurements must be traceable to SI units by an unbroken chain of calibrations of reference standards

Expert witness.

Assist the court by providing conclusions that are: Sound scientific practice, accepted interpretation of facts by scientific community, untainted by foreign interests