Process Management and Control Henry P Julius
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
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