1. Purchasing & Storage Management Instructor Abdel Fatah Afifi MA&T, MBA, PCT, ACPA 2 nd Semester 09/10

2. Afifi, Purchase, 2nd Semester 2009/20102 Chapter IV Quality Management and Customer Service

3. Afifi, Purchase, 2nd Semester 2009/20103 Defining Quality Quality is ….. Invisible when GOOD Impossible to ignore when BAD

4. Afifi, Purchase, 2nd Semester 2009/20104 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 ”

5. Afifi, Purchase, 2nd Semester 2009/20105 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

6. Afifi, Purchase, 2nd Semester 2009/20106 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

7. Afifi, Purchase, 2nd Semester 2009/20107 Quality systems Objectives 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

8. Afifi, Purchase, 2nd Semester 2009/20108 Factors influencing quality Post analyticalAnalyticalPre analytical Recording Laboratory professionals Right specimen Interpretation Reagents Right collection Turnaround time Equipment Right labeling Report to right user Selection of test - SOP Right quantity RecordsRight transport Bio-Safety Right storage

9. Afifi, Purchase, 2nd Semester 2009/20109 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).

10. Afifi, Purchase, 2nd Semester 2009/201010 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

11. Afifi, Purchase, 2nd Semester 2009/201011 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

12. Afifi, Purchase, 2nd Semester 2009/201012 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

13. Afifi, Purchase, 2nd Semester 2009/201013 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

14. Afifi, Purchase, 2nd Semester 2009/201014  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

15. Afifi, Purchase, 2nd Semester 2009/201015 ……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

16. Afifi, Purchase, 2nd Semester 2009/201016 ……What should be covered Deviations  Planned deviations  Unplanned deviations  Variance  Errors  Record of all the above – Action taken

17. Afifi, Purchase, 2nd Semester 2009/201017 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

18. Afifi, Purchase, 2nd Semester 2009/201018 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

19. Afifi, Purchase, 2nd Semester 2009/201019 DOCUMENTATION 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 Reports

20. Afifi, Purchase, 2nd Semester 2009/201020 “ 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

21. Afifi, Purchase, 2nd Semester 2009/201021 Material Control  Specification For Raw Materials  Specification For Supplies/Disposables  Inspection & Acceptance Criteria For Supplies/ Disposables/Raw Material.  Inventory Control Procedures For Supplies/Disposables.

22. Afifi, Purchase, 2nd Semester 2009/201022 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

23. Afifi, Purchase, 2nd Semester 2009/201023 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

24. Afifi, Purchase, 2nd Semester 2009/201024 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

25. Afifi, Purchase, 2nd Semester 2009/201025 Quality Assurance is a dynamic process It is a journey towards the destination

26. Afifi, Purchase, 2nd Semester 2009/201026 Quality assurance Equipment Management

27. Afifi, Purchase, 2nd Semester 2009/201027 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

28. Afifi, Purchase, 2nd Semester 2009/201028 Quality assurance Equipment Criteria Selection Purchase / Acquisition Installation Calibration /Validation Maintenance - Service and repair Replacement

29. Afifi, Purchase, 2nd Semester 2009/201029 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

30. Afifi, Purchase, 2nd Semester 2009/201030 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

31. Afifi, Purchase, 2nd Semester 2009/201031 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.

32. Afifi, Purchase, 2nd Semester 2009/201032 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

33. Afifi, Purchase, 2nd Semester 2009/201033 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

34. Afifi, Purchase, 2nd Semester 2009/201034 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.

35. Afifi, Purchase, 2nd Semester 2009/201035 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

36. Afifi, Purchase, 2nd Semester 2009/201036 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.

37. Afifi, Purchase, 2nd Semester 2009/201037 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

38. Afifi, Purchase, 2nd Semester 2009/201038 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

39. Afifi, Purchase, 2nd Semester 2009/201039 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

40. Afifi, Purchase, 2nd Semester 2009/201040 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

41. Afifi, Purchase, 2nd Semester 2009/201041 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.

42. Afifi, Purchase, 2nd Semester 2009/201042 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

43. Afifi, Purchase, 2nd Semester 2009/201043 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

44. Afifi, Purchase, 2nd Semester 2009/201044 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