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

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

Quality Assurance Standard Operating Procedures

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).

STANDARD OPERATING PROCEDURES (SOPs)  Standard operating procedures describe in a detailed form the activities performed  Provide uniformity, consistency and reliability in each of the activities to be performed  Reduce systematic errors  Provide training and guidance for new staff

SOP for material and reference standards control

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

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

Quality assurance Equipment Management

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

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

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.

…..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

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

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.

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

PERFORMANCE CHECKS Equipment performance degrades over time. Check the equipment regularly for its performance – daily, weekly, monthly etc. 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

Equipment Management program Assign responsibilities for all activities Train all personnel on equipment Develop standard operating procedures for equipment Maintain history card and logbooks of equipment Monitor equipment

Equipment Maintenance : Documents and records Equipment History card : A record for equipment inventory Name, Model #, Serial # Location in use 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

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

Quality Assurance is responsibility of…. All Staff