Dr.Mrs.Nalini Ramamurty King Institute of Preventive Medicine, Chennai

1. Dr.Mrs.Nalini Ramamurty King Institute of Preventive Medicine, Chennai Quality assurance

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

3. 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

4. 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 interlaboratory comparability

5. 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

6. The 5M’s of Quality • Man • Material • Machinery • Manuals/Methodology ( SOP) • Motivation

7. Factors influencing quality:

8. Quality Assurance Standard Operating Procedures

9. 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. 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. 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. 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. 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 ………cont

14. ……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 ………..cont

15. ……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. ……What should be covered • Deviations • Planned deviations • Unplanned deviations • Variance • Errors • Record of all the above – Action taken

17. 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. 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. King Institute of Preventive Medicine, National Polio Laboratory - Department of Virology, Standard Operating Procedure - 001 RECEIPT OF STOOL SPECIMENS Equipment Consumables Registers Eg Date of issue of this version:1/4/2003 Page Number 1/4 Objectives : Procedure to be followed for receiving and storing stool samples of AFP Cases. Scope : This document contains the procedure that is adopted when stool specimens are received from cases of AFP from Tamilnadu, Andhra Pradesh, Pondicherry, Andaman & Nicobar. Definition:  Stool sample carrier – marked with red for stool samples only Deep freezer –20 (1) – preparation of ice pack Refrigerator No.3 – for pre processing storage of samples LRF – Lab request form. AFP – Acute flaccid paralysis. Place of testing: Requirements: Tech/Scientist incharge Checked by Authorized by

20. 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

21. “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

22. FDA CFR 211 - Sec. 211.194 Laboratory Records (In part). • Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows: • A description of the sample received for testing with identification of source (that is, location from where sample was obtained), quantity, lot number, date sample was taken, and date sample was received for testing. • A statement of each method used in the testing of the sample. The suitability of all testing methods used shall be verified under actual conditions of use. • A complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the lot tested.

23. A record of all calculations performed in connection with the test, including units of measure, conversion factors etc. • Results of tests and how the results compare with established standards of identity, strength, quality, and purity. • The initials or signature of the person who performs each test and the date(s) the tests were performed. • The initials or signature of a second person showing review for accuracy, completeness, and compliance • Complete records shall be maintained of any modification of an established method employed in testing. • Complete records shall be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions. • Complete records shall be maintained of the periodic calibration of laboratory instruments and recording devices

24. SOP for material and reference standards control

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

26. SOP for Reagent and Standards Quality ControlThe accuracy and precision of test results and test methods is dependant on the reliability, authenticity and control over reference standards, reagents and stock solutions..Similarly the retrospective testing of materials and product is dependant on the protection and storage of retention samples • Primary Standards may be obtained from • National reference labs • World Health Organisation (WHO) for biologicals • In House Secondary Standards • Standardised against primary standards using definitive methods

27. 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

28. 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

29. 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

30. Quality Assurance is a dynamic process It is a journey towards the destination

31. Thank you

32. Quality assurance Equipment Management

33. 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

34. Quality assurance Equipment Criteria Selection Purchase / Acquisition Installation Calibration /Validation Maintenance - Service and repair Replacement

35. Selection - design & purchase • Specify what you need the machine to do. • Specify accuracy and precision • Specify details of installation site. • Get the machine you specify. Sales personnel are trained to sell a refrigerator to an eskimo, so beware. check the fine print!!! • check the firms reputation & its service backup.

36. …..Selection Criteria • 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

37. 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

38. 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.

39. 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

40. 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

41. 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.

42. Equipment Management program • Assign responsibilities for all activities • Routine maintenance • Preventive maintenance • Train all personnelon equipment management • Develop standard operating proceduresfor maintenance • Maintain history card and logbooks • Monitor equipment management activities : • Routinely reviewing all records • Ensuring all procedures are followed

43. 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.

44. 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 parts

45. 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

46. 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

47. 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

48. 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.

49. 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

50. 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