Transcript Documentation of a Quality Management System

Documentation of a
Quality Management
System
Viki Massey
Quality Coordinator
A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London
Hierarchy of Documents

Level “A” – Policies
– What to do

Level “B” – Processes
– How it happens
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Level “C” – Procedures
– How it’s done

Others
– Forms
– Records
Policy (Level A) Development

Audience
– Management
– Assessors
– New Employees

Address “Big Picture”
– What are we about?
– Why do we do what we do?
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Address Key Elements
Process (Level B)
Development

Audience
– Management
– Assessors
– Staff
– Process Improvement Teams

Address the path of workflow
 Describe how things happen here
Process Development

Generally Flow Charts or Table
Benefits of Flow Charts:
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Identify essential steps
Shows dead ends
Redundancies
Identify overly complex flows
Identify responsibility
Procedure Development

Audience
– Assessors
– Staff

Address specific steps
 Layout that enables the user to perform task
correctly
Document Management

Document Control
– Document organization

Document Development
– New documents and changes to existing
documents
Document Control

Master index
 Master file
 Document numbering / revision
 Distribution
 Archiving
Document Numbering

Purpose of numbering
– Unique identifier
– Quick cue to the content of the document
Chem-qseIMP-B-1234 rev 03
Lab – QSE – Level – Number - Revision
Document Distribution

Electronic vs. Paper Distribution
 Electronic – determine accessibility by
individual, department
– Read / Write access

Paper – Official copies only
– Location of binders
– Updating copies
Document Archiving

Electronic vs. Paper
 Electronic – ability to do an electronic
comparison
 Paper
– Storage
– Organization
QMP-LS Quality Manual
Instructions

Policies
 Usually 1 volume
 Electronic or paper
 Easy to update
 Available / used by all personnel
 Maintained by quality manager
 Will be validated during assessment
QMP-LS Quality Manual
Content

Description of laboratory
 Quality policy statement
 Laboratory policies (may include processes)
 References to supporting process and
procedures
 Reflect actual practice
Quality Manual Review

Prior to each assessment visit, labs submit a copy
of their quality manual to QMP-LS
 QMP-LS will assess the physical aspects of the
manual (i.e. table of contents, introduction,
glossary etc)
 QMP-LS will conduct a pre-assessment of the
facility’s policies as defined by the requirements.
 A report will be provided for the benefit of both
the facility and the OLA assessment team to
highlight those areas for which further information
or validation is sought.