Process Management and Control

Henry P Julius

Welcome

Welcome to the Process Management and Control

Module

Module Objectives

At the end of this module, participants will be able to: Discuss the overview of QSE Process Management and Control Illustrate the use of Process flow charts and tables

12 QSEs for Quality Management

Describes processes directly / indirectly relating to the Path of Workflow

Optimise Effectiveness in meeting requirements

Efficiencies in Resources like Human Resources

QSE: Process Management is involved in all the 12 QSE’s Transform each QSE into actions

QSE: Process Management is involved in the entire Path of the Laboratories workflow i.e.:

QSE: Process Management

Pre-examination process

Examination Process Post examination Process

Process Maps / Flow Charts

Process maps or flow charts are prepared for all activities in each QSE Identify activities

o Which SOPS are needed

o Possible situations that may result in miscommunication

o Quality Failures

o Causes of inefficiency

Process Maps and Flow Chart

What Happens Who is responsible? Procedure / instruction to follow

Need for a new or changed document is submitted

Anyone Document change request form

Copy of current version retrieved

Document control coordinator

Retrieving a revision copy Document control system

New document type ID as -policy -SOP Form

Supervisor Selecting the appropriate Document template

Document is drafted or edited

Assigned writer How to complete Document Template

Independent review and verification performed

Assigned reviewer Reviewing New or Revised document

Process Map: Document Creation, review and approval

What Happens Who is responsible ? Procedure / instruction to follow

Approval signatures Obtained

Assigned Approvers Approving New or changed documents in the document control system

Checklist review completed

Document control coordinator

Reading New or changed documents for release

Staff notification made (or proceed to staff Training Process)

Supervisor Email staff notification of new or changed document

Process Map: Document Creation, review and approval (continued…)

Document Creation, Review and Approval Process Flow

Clinical and Laboratory Standards Institute

- Policy - Process - Procedure - Form

Process critical to QMS needs to be validated or verified before being implemented

If they are in-house - validation and verification

If they are adopted from the manufacturer’s design - verification only Applies to all new instruments , reagents, analytical systems, examination

methods, etc.

Need to demonstrate that the reportable ranges and examination performed are comparable to that of the manufacturer’s claims

Process Validation and /or Verification

All processes identified and documented need to be controlled to ensure: Maximum efficiency and effectiveness

That the process functions as designed

That the process contributed to the stated quality objectives and goals

Controls are put in place to prevent and /or detect errors PTS

Non-conformance / corrective action Trend analysis

Monitoring of established Quality indicators

Statistical Techniques – histograms, Paretro Charts, etc.

Process Control

Group 1: all related pre-examination activities

Group 2: all related examination activities

Group 3: all related Post examination activities

Activity

Develop a process for the introduction of a new test method (test offered) at your laboratory by means of Flow charts and Tables.

Process Management and Control is applicable to all 12 QSE’s and the entire Path of the workflow

Identifies needed Policies, SOPs and forms

Optimizes effectiveness and efficiencies

Can prevent medical errors from occurring

Process can be controlled and evaluated by means of: PTS

Audit

Quality indicators

Statistical analysis

Summary

Application of a Quality Management System Model for Laboratory Services, Approved Guideline – 3rd Edition GP26. Vol.24. No. 36

Quality Management System: A Model for Laboratory Services, Approved Guideline - 4th Edition QMS01-A4

A Quality Management System Model for Health Care; Approved Guideline— 2nd Edition HIS-A2 Vol. 24. No 37

References & Links

References

Wrap Up

Participants are now able to: Discuss the overview of QSE Process Management and Control Illustrate the use of Process flow charts and tables

Questions

16