Laboratory management

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Laboratory management Quality control

• by
• Dr. Le Roy C. Dowey
• LC.Dowey_at_Ulster.ac.UK

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What type of Labs?

• Teaching schools universities
• Research universities, institutes industry
• Industrial food, chemical, engineering
• Health care haematology, biochemistry,
  histopathology, bacteriology

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Managing a laboratory

• A lab manager is responsible for the efficient
  day to day running of a laboratory including
• Staff
• Safety
• Security
• Consumables
• Equipment
• Verification of data storage
• Paperwork finance
• Stock control

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Managing a laboratory

• A lab manager is responsible by law and could
  face prosecution resulting in a heavy fine or
  imprisonment

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Managing a laboratory the law

• Health Safety at Work Act 1974
• Management of Health Safety at Work Regulations
  1999
• Electricity at Work Regulations 1989
• Workplace (Health, Safety and Welfare)
  Regulations 1992
• Provision and Use of Work Equipment Regulations
  1998.

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Laboratory staff

• Duties
• Qualifications
• Training
• Holidays
• Overtime
• Promotion
• Discipline

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Safety - hazards

• Biohazards
• Blood samples, human tissue, agar plates
• Chemicals
• Acids, alkaline, flammable, controlled material
• Physical
• Electrical equipment, laboratory layout

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Specialist facilities
Microbiology
Blood sampling
Specialist facilities (e.g. research)
Radiation
Animal house
Tissue culture
Local safety rules exist for each of these areas
to cover specialist hazards (e.g. Hepatitis B,
allergic reactions).
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Safety - solutions

• Training
• Lab cleanliness
• Protective wear
• Proper disposal of biohazards
• Storage of chemicals
• Proper procedures for chemical spills
• PAT - testing

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Security

• Theft
• Chemical / drug abuse
• Intellectual property rights
• Industrial espionage
• Activists
• The Medicines Act 1968
• Misuse of Drugs Act 1971
• Data Protection Act 1998

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Consumables

• Function suitability
• Cost value for money
• Shelf life
• Identification labelling
• Storage - location
• Hazards - Material hazard data sheet

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Equipment

• Function suitability
• Cost value for money
• Training of staff
• Servicing contracts
• Repairs
• Location
• Hazards PAT testing

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Portable Appliance Testing

• Portable appliance - An appliance of less than
  18kg in mass that is intended to be moved whilst
  in operation or an appliance which can easily be
  moved from one place to another, e.g. vacuum
  cleaner, toaster, food mixer, etc.
• Movable equipment (transportable) - equipment is
  either 18 kg or less in mass and not fixed, e.g.
  electric fire, or equipment with wheels, castors
  or other means to facilitate movement by the
  operator as required to perform its intended use,
  e.g. air conditioning unit
• Hand Held equipment or appliances - intended to
  be held in the hand during normal use, e.g. hair
  dryer

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Portable Appliance Testing

• Stationary equipment or appliances - equipment
  has a mass exceeding 18kg and is not provided
  with a carrying handle, e.g. refrigerator
• Fixed Equipment/appliances - equipment or an
  appliance which is fastened to a support or
  otherwise secured in a specific location, e.g.
  bathroom heater
• Appliances/equipment for building in - equipment
  intended to be installed in a prepared recess
  such as a cupboard or similar e.g. built in
  electric cooker
• Information technology equipment - electrical
  business equipment such as computers and mains
  powered telecommunications equipment, and other
  equipment for general business use, such as mail
  processing machines, VDU's photo-copiers

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Verification of data storage

• Quality control materials
• Staff trained
• Equipment at a suitable standard servicing, PAT
  testing
• Databases macros developed to make analysis of
  results more efficient

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Paperwork finance

• Staff records
• Training
• procedures
• Sickness
• Holidays
• Overtime
• Stock control
• consumables capital
• Equipment records
• servicing
• PAT testing
• Databases much more efficient

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Stock control

• This is the control of consumables and equipment
• Current needs
• Prepare for the future
• Review companies put up for tender
• Pricing value for money budget
• Date of purchase
• Date of last use
• Stock take when necessary
• Regularly used items standing order
• Why ?
• Who?

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Lab supply companies

• Davidson Hardy (Laboratory Supplies) Ltd,
  Belfast
• Analab Analytical Laboratory Supplies Ltd,
  Dromore
• Andor Technology, NI USA Japan
• Sigma / Aldrich, Worldwide
• Sigma-Aldrich operates in 34 countries and has
  6,000 employees providing service worldwide.

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Quality standards

• British Standards (BS) or other national
  standards
• European standards (EN)
• International standards (ISO)
• Industry standards recognised nationally

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Do you recognise these symbols
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Quality Assurance (QA) Establishing Confidence
in Reported Data.

• The primary products of any laboratory are the
  analytical data reported for specimens examined
  by that laboratory.
• QA includes all of the activities associated with
  ensuring measurements are made properly,
  interpreted correctly, and reported with
  appropriate estimates of error and confidence
  levels.
• QA activities also include those maintaining
  appropriate records of specimen/sample origins
  and history (sample-tracking), as well as
  procedures, raw data, and results associated with
  each specimen/sample.

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Quality Assurance (QA) Establishing Confidence
in Reported Data.

• The various elements of QA are itemized here
•  
• Standard Operating Procedures (SOP's).
• Statistical procedures for data evaluation
• Instrumentation validation
• Reagent/materials certification
• Analyst certification
• Lab facilities certification
• Specimen/Sample tracking

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Internal benefits of a QMS

• ImprovesManagement efficiency
  planningproblem-solvingsupplier control
  communicationsability to changedisciplinestaff
  morale
• Reducesduplicate effortre-workwastecostsstaf
  f turnover

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External benefits of a QMS

• Improvesproduct and service qualitycustomer
  satisfactionrepeat salescompany image
• Reduces
• complaintswarranty claims

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Type of QMS depends on type of lab

• Company providing service or product
• ISO9000
• Company with end product
• HACCP
• Healthcare
• Diagnostic or research
• GLP GCP
• Manufacture
• GMP

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The ISO 90002000 Series

• The ISO 90002000 series of standards replace the
  1994 version of ISO 9000.
• It is designed to apply to all types of business
  and focuses on delivering customer satisfaction.
• There is less emphasis on paperwork and each
  business decides how best to document the
  planning, operation and control of its processes.

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The ISO 90002000 Series

• ISO 90002000 consists of a number of standards.
• ISO 90002000 sets out the fundamentals of
  quality management requirements and contains a
  glossary of terms used across the ISO 9000
  standards.
• ISO 90012000 is the new, unified standard
  against which businesses can be certificated.
• ISO 90042000 is a new standard to help with
  developing continual improvement.

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In the food and drink industry

• European Community Directive 1993
• Food Safety Act 1990
• HACCP

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Quality in healthcare labs

• GCP good clinical practice
• GLP good laboratory practice
• Declaration of Helsinki 1996
• Governing bodies
• Medicines and Healthcare products Regulatory
  Agency - MHRA - UK
• Food and drug administration - FDA USA

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THE PRINCIPLES OF ICH GCP

• Clinical trials should be conducted in accordance
  with the ethical principles that have their
  origin in the Declaration of Helsinki, and that
  are consistent with GCP and the applicable
  regulatory requirement(s).
• Before a trial is initiated, foreseeable risks
  and inconveniences should be weighed against the
  anticipated benefit for the individual trial
  subject and society. A trial should be initiated
  and continued only if the anticipated benefits
  justify the risks.
• The rights, safety, and well-being of the trial
  subjects are the most important considerations
  and should prevail over interests of science and
  society.

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THE PRINCIPLES OF ICH GCP

• The available nonclinical and clinical
  information on an investigational product should
  be adequate to support the proposed clinical
  trial.
• Clinical trials should be scientifically sound,
  and described in a clear, detailed protocol.
• A trial should be conducted in compliance with
  the protocol that has received prior
  institutional review board (IRB) / independent
  ethics committee (IEC) approval / favourable
  opinion.
• The medical care given to, and medical decisions
  made on behalf of, subjects should always be the
  responsibility of a qualified physician or, when
  appropriate, of a qualified dentist.

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THE PRINCIPLES OF ICH GCP

• Each individual involved in conducting a trial
  should be qualified by education, training, and
  experience to perform his or her respective
  task(s).
• Freely given informed consent should be obtained
  from every subject prior to clinical trial
  participation.
• All clinical trial information should be
  recorded, handled, and stored in a way that
  allows its accurate reporting, interpretation,
  and verification.

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THE PRINCIPLES OF ICH GCP

• The confidentiality of records that could
  identify subjects should be protected, respecting
  the privacy and confidentiality rules in
  accordance with the applicable regulatory
  requirement(s).
• Investigational products should be manufactured,
  handled, and stored in accordance with applicable
  good manufacturing practice (GMP). They should be
  used in accordance with the approved protocol.
• Systems with procedures that assure the quality
  of every aspect of the trial should be
  implemented.