Purchasing & Storage Management Instructor Abdel Fatah Afifi MA&T, MBA, PCT, ACPA 2 nd Semester...
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Transcript of Purchasing & Storage Management Instructor Abdel Fatah Afifi MA&T, MBA, PCT, ACPA 2 nd Semester...
Purchasing & Storage Management
Instructor
Abdel Fatah AfifiMA&T, MBA, PCT, ACPA
2nd Semester 09/10
Afifi, Purchase, 2nd Semester 2009/2010
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Chapter IV
Quality Management and Customer Service
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Defining Quality
Quality is…..
Invisible when GOODImpossible 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
customer”
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Quality assurance
Definition It is the sum total of all lab activities
that are undertaken to ensure generation of accurate and reliable results.
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 systemsObjectives
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 analyticalAnalyticalPost analytical
Right specimenLaboratory professionals
Recording
Right collectionReagentsInterpretation
Right labelingEquipmentTurnaround time
Right quantitySelection of test - SOP
Report to right user
Right transportRecords
Right storageBio-Safety
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STANDARD OPERATING PROCEDURE (SOPs)
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 (SOPs)
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
staff
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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 procedures.
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 well.
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 SOP)
Preparation and maintenance of work area Washing and sterilization Decontamination Testing area
Receipt of samples, Recording and labeling Storage and discarding
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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
………..cont
……What should be covered
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……What should be covered Equipments Indent, purchase, installation and
validation Maintenance
Daily checks and records Periodic calibration and validation Trouble shooting and action to be taken Annual maintenance In case of accidents – action to be taken
……cont
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……What should be covered
Deviations Planned deviations Unplanned deviations Variance Errors Record of all the above – Action
taken
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Format of an SOP
Title : descriptiveCode : Number relating to procedure and revisionsObjective : Aim of the procedure clearly describedScope : The operating unit and field of applicationDefinitions : 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 SOPDocumentation : 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
SOP 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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DOCUMENTATION
Main objectiveto establish, monitor and record “Quality” for all aspects of Good Laboratory Practices and Quality Control”.
Type of documents Standard operating proceduresProtocols of tests, resultsReports
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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
test 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
Supplies/Disposables Inspection & Acceptance Criteria For
Supplies/ Disposables/Raw Material. Inventory Control Procedures For
Supplies/Disposables.
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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
process
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
Ensures reliable test results and customer satisfaction thus credibility of the lab
Reduces interruption of services and delays in reporting due to breakdowns
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Quality assurance Equipment Criteria
SelectionPurchase / AcquisitionInstallationCalibration /ValidationMaintenance - Service and repairReplacement
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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
support 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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INSTALLATION The equipment should be checked for all its
design parameters. Ensure you got what you wanted.
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 procedures
Establish maintenance program Provide training for all operators –
trouble shoot
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PERFORMANCE CHECKS
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 maintenance
Maintain history card and logbooks
Monitor equipment management activities : Routinely reviewing all records Ensuring all procedures are followed
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PREVENTIVE MAINTENANCE
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
firm.
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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
information• 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 equipment 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
stores Store samples appropriately
Seek help from manufacturer or other technical expert
Place a malfunction notice on equipment
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When in problem what needs to be done? TROUBLE SHOOT
Does the equipment display any error messages.
Check manufacturers instruction Could you identify the cause to the problem
- a fluctuation in power supply, temperature, water, reagent problem, sample problem etc - MAKE ONE CHANGE AT A TIME)
Inform the maintenance department / firm giving all details
Have the engineer prepare a detailed service report
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
checks
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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 results
Safety Fewer interruptions of work Lower repair costs Elimination of premature
replacement Reduction of variation in test
results