Purchasing Chap

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					Purchasing & Storage

     Abdel Fatah Afifi
      MA&T, MBA, PCT, ACPA
      2nd Semester 09/10
Chapter IV

 Quality Management
 and Customer Service

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 Defining Quality
Quality is…..
Invisible when GOOD
Impossible to ignore when BAD

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Quality assurance
   Quality is simply meeting the customer’s
    requirements; this has been expressed
   in many ways by others:
   • “fitness for purpose or use”
   • “the totality of features and characteristics of a
    product or service that bear
   on its ability to satisfy stated or implied needs”
   • “the total composite product and service
    characteristics of marketing,
   engineering, manufacture, and maintenance
    through which the product and
   service in use will meet the expectation by the

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    Quality assurance
   It is the sum total of all lab activities
    that are undertaken to ensure
    generation of accurate and reliable
   What is the Objective?
    To ensure credibility of the lab and
    generate confidence in lab results
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    Components of Quality assurance

   Internal Quality control: IQC
       Nature: Concurrent
       performed by: lab staff
       Objective: Reliable results on a daily basis

   External quality assessment: EQA
       Nature: Retrospective to evaluate IQC
       Performed by: Independent agency
       Objective: Ensure inter-laboratory comparability

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Quality systems
    To prevent risks
    To detect deviations
    To correct errors
    To improve efficiency
    To reduce costs

   How : By establishing a quality manual defining
      Organizational structure – Staff
      Responsibilities
      Procedures and processes
      Resources
      Documentation

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  Factors influencing quality
Pre analytical      Analytical                    Post analytical

Right specimen      Laboratory                    Recording
Right collection Reagents                         Interpretation

Right labeling      Equipment                     Turnaround
Right quantity      Selection of test Report to right
                    - SOP             user
Right transport     Records

Right storage       Bio-Safety
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 An authorized written procedure giving
 instructions for performing operations
 not necessarily specific to a given
 process, product or material (e.g.
 equipment operation, maintenance
 and cleaning; validation; cleaning of
 premises and environmental control;
 sampling and inspection).

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   Standard operating procedures describe
    in a detailed form the activities
    performed in the laboratory
   Provide uniformity, consistency and
    reliability in each of the activities
    performed in the laboratory
   Reduce systematic errors
   Provide training and guidance for new
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SOPs should be
   Written instructions that specify how a
    test or procedures is to be performed.
   How a piece of equipment is operated,
    maintained and calibrated.
   Describes “Standard” approved
   Revision … when planned changes are
    made or annually

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SOPs should be (Cont..)
   Original – maintained in a central file.
   Copies – distributed to locations.
   Written by the person performing the
    procedure or who knows the procedure
   Supervisor review SOPs for completeness
    and content.
   QA or QC staff approval

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What should be covered
under SOP
   General: Document Preparation (SOP for
   Preparation and maintenance of work
       Washing and sterilization
       Decontamination
       Testing area
   Receipt of samples,
       Recording and labeling
       Storage and discarding

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……What should be covered
    Laboratory operations
    Receipt of reagents, standards, etc – storage
    Preparation of reagents – labeling and storage
    Test procedures
    Reference material identification, handling,
     storage and use
    Results: – results, deviations, errors
    Reports: – generation, distribution
    Archives maintenance
    Staff   – Training, GLP, staffing pattern

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    ……What should be covered
   Equipments
   Indent, purchase, installation and
   Maintenance
      Daily checks and records

      Periodic calibration and validation

      Trouble shooting and action to be
      Annual maintenance

      In case of accidents – action to be
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……What should be covered

 Planned deviations

 Unplanned deviations

 Variance

 Errors

 Record of all the above – Action

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   Format of an SOP
Title         : descriptive
Code          : Number relating to procedure and revisions
Objective     : Aim of the procedure clearly described
Scope : The operating unit and field of application
Definitions : Meaning of principle terms used
Description : Operating instructions clearly
                described without any ambiguity,
                understood by all staff with flow diagrams
Safety        : Measures to be kept in mind when
               executing the SOP
Documentation : Protocol, Data sheets and measurements
References : Used to draw up the SOP

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Format on each page of SOP
   Logo and name of the organization
   Department or unit issuing the SOP
   Title and date of issue
   Signature of person who drew up the
   Signature of person who reviewed it
   Signature of person who authorized it
   Duration of validity
   Date of review
   Code
   Page number and total number of
    pages in the document
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Main objective
 to establish, monitor and record “Quality” for
 all aspects of Good Laboratory Practices and
 Quality Control”.

Type of documents
 Standard operating procedures
 Protocols of tests, results

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“IF you have not documented it                 you have
not done it”

Laboratory records
   Description and identification of sample received
   Description of method of testing
   Record of all data secured in the course of the
   Record of test results and how they compare with
    standards of identity, strength and quality
   Record of all deviations and modification of test
   Record of standardization of reference standards
   Record of calibration of equipments

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Material Control
   Specification For Raw Materials
   Specification For
   Inspection & Acceptance Criteria For
    Supplies/ Disposables/Raw Material.
   Inventory Control Procedures For

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SOP for control over Standards (reference material)

   Register, Logging and Inventory System
        Purchased
        Supplied
   Labelled
        complete description (name, source, Lot number)
        strength, activity and confidence interval
        storage conditions
   Protected (heat, light, humidity, irradiation, vibration)
   Custodian of Standards
   SOP for Standards Management
        selection, standardisation, change, and control
        Standard Lot Number must appear in testing record

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SOP for Standard Solutions & Reagents

   QC Program for Incoming Lots of Reagents
   Standard Procedure for Preparation (BP and USP)
   Records of Standardisation
   Storage and Protection Conditions
   Validated expiry or re-standardisation date
   Complete labelling; each standard or stock solution must
    be labelled with:
       Standard Name
       Batch Number
       Date of preparation
       Date of expiry
       Storage conditions
                                                      Strength

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SOP for Laboratory Control
   Record Review : Quality Monitors

   Review & Trending Of Error Reports

   Review Of Field Complaints

   Review Of Quality Control Data

   Internal Audits : Review Trends

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  Quality Assurance
     is a dynamic

    It is a journey
towards the destination

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   Quality assurance

Equipment Management

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How does good equipment
management affect Quality assurance

   Ensuresreliable test results
   and customer satisfaction
   thus credibility of the lab

   Reduces interruption of
   services and delays in
   reporting due to
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Quality assurance
Equipment Criteria

Purchase / Acquisition
Calibration /Validation
Maintenance - Service and repair

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Selection - design & purchase
   Use - Matching equipment with service
    Performance characteristics and safety
   Facility requirements - - Availability of
    space, accessibility
   Cost
   Supply of reagents
   Ease of operation
   Warranty
   Availability of manufacturer technical
   Service Contracts

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Acquiring Equipment
   Purchase, Lease, or Rent
      Central acquisition

      Bulk procurement

   Donor provided
   Conditions of contract
      Parts Manual

      Installation

      Operators’ Manual

      Trial period

      Contents of service contracts

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   The equipment should be checked for all its
    design parameters. Ensure you got what you

   Confirm responsibility for installation

   Check the Performance of equipment under
    adverse conditions

   A number of check runs of known samples
    may be necessary to validate the equipment.

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Post Installation
     Establish inventory record
     Define conditions
     Develop and implement SOP for
      calibration, performance
      verification, and operating
     Establish maintenance program
     Provide training for all operators –
      trouble shoot

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Equipment performance degrades over time.

   Check the equipment regularly for its
    performance – daily, weekly, monthly etc.
       Eg; Autoclave: Daily use - autoclave indicator
        tapes - Monthly validation by BI
   Performance checks must be conducted after
    repair of equipment before putting it into
    routine use.
   Ensure a cleaning programme after each use
   Determine frequency of routine calibration

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Economics of maintenance
Maintenance is a costly activity.
- How much maintenance is needed?
- Extent of the maintenance facilities and
  strength of maintenance squad.
- When and how often ??

- Is centralized maintenance desirable? or

- Should maintenance be done only by out
  side contractors.

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Equipment Management program
   Assign responsibilities for all activities
       Routine maintenance
       Preventive maintenance

   Train all personnel on equipment management

   Develop standard operating procedures for

   Maintain history card and logbooks

   Monitor equipment management activities :
       Routinely reviewing all records
       Ensuring all procedures are followed

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   Options
       In house service of small equipment, e.g.,
        microscopes, washers, pipettes
       Team of biomedical service technicians or
        AMC by manufacturer
   Regular schedule is usually provided by
    the firm.
   Ensure strict compliance of the schedule.
   Ensure all jobs have been performed as
    per checklist.
   Verify the quality of job performed by the

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Equipment Maintenance :
     Documents and records
   Equipment History card :A record for
    equipment inventory
     • Name, Model #, Serial #
     • Location in lab
     • Date purchased
     • Manufacturer and vendor contact
     • Warranty, expiration date
     • Spare parts

    For each piece of equipment:
          Establish routine maintenance plan
          Establish required function checks
          Develop a list of spare
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Equipment Maintenance : Documents
and records
   Develop written procedures for all
      Concise step-by-step instructions
   Establish maintenance record to track:
      function checks and routine maintenance
      calibration
      manufacturer’s service
      Nature of Records
         Charts and graphs

         Logs

         Checklists

         Service Reports

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Spare Parts
Establish and maintain an inventory of most frequently
   used spare parts. Include in record of inventory:

          Spare parts per equipment
          Part number
          Average use
          Minimal # of items to be stored
          Cost and date of ordering
          Dates of entry and issuance of part from
           inventory stock
          Balance of items remaining in inventory

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When in problem what needs to be done

   Do NOT use the equipment
   Options for testing:
       Refer samples to nearby laboratory
       Obtain backup instrument from central
       Store samples appropriately
   Seek help from manufacturer or
    other technical expert
   Place a malfunction notice on

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When in problem what needs to be done?

   Does the equipment display any error
   Check manufacturers instruction
   Could you identify the cause to the problem -
    a fluctuation in power supply, temperature,
    water, reagent problem, sample problem etc
   Inform the maintenance department / firm
    giving all details
   Have the engineer prepare a detailed service
   After rectification have all performance
    checks done.

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Documentation of problems
Develop a problem log record for
 each piece of equipment
    •   Date problem occurred, removed
        from service
    •   Reason for breakdown or failure
    •   Corrective action taken
    •   Date returned to use
    •   Change in maintenance or function

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Retiring Equipment / Disposal
   When?
       When experts indicate not repairable or
        outmoded , or spares not available
   Why?
       Prevent inaccurate test results
       Free up valuable space
   How?
       Consider biohazard, follow
       safety disposal procedures

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Benefits of a Maintenance Program
   Greater confidence in the
   Safety
   Fewer interruptions of work
   Lower repair costs
   Elimination of premature
   Reduction of variation in test

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