purchasing & storage management instructor abdel fatah afifi ma&t, mba, pct, acpa 2 nd...

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

purchasing & storage management instructor abdel fatah afifi ma&t, mba, pct, acpa 2 nd...

Documents

quality quality

quality assurance quality

customer slide

quality management

quality manual

bad slide

customer service slide

nd semester