The document discusses models for establishing quality management systems for technical communications departments. It describes a Quality Management System (QMS) that includes quality planning, control, assurance and improvement. A Capability Maturity Model (CMM) establishes five levels of process maturity from initial to optimizing. The Cost of Quality (CoQ) model categorizes costs into prevention, appraisal, internal failure, and external failure. The document outlines elements to include in a technical communications QMS and provides an implementation approach based on forming working groups, establishing standard operating procedures, and measuring outcomes over time.
2. p.2
Agenda
• Background
• Model 1: Quality Management System (QMS)
• Model 2: Capability Maturity Model (CMM)
• Model 3: Cost of Quality (CoQ)
• Elements of Quality
• Implementation
• Final Thoughts
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Background:
Carestream Health, Inc.
Health imaging hardware, software, and
services
Global sales and service
Regulated products
Product development sites around the
world
5. p.5
Model 1:
Quality Management System (QMS)
AT A GLANCE
Background
QMS
CMM
CoQ
Elements
Implementation
Final Thoughts
The organizational structure, procedures, processes and
resources needed to implement quality management.
Quality management includes:
Source: http://en.wikipedia.org/wiki/Quality_management_system
• Quality planning
• Quality control
• Quality assurance
• Quality improvement
6. p.6
Elements of a QMS
Organizational structure
Responsibilities
Methods
Data management
Processes
Resources
Customer satisfaction
Continuous improvement
Product quality
Source: http://en.wikipedia.org/wiki/Quality_management_system
7. p.7
Elements of a QMS for Medical Devices
Personal training and qualifications
Controlling the product design
Controlling documentation
Controlling purchasing
Product identification and traceability
at all stages of production
Controlling and defining production
and process
Defining and controlling inspection,
measuring, and test equipment
Validating processes
Product acceptance
Controlling nonconforming product
Instituting corrective and preventive action
when errors occur
Labeling and packaging controls
Handling, storage, distribution,
and installation
Records
Servicing
Statistical techniques
Source: http://en.wikipedia.org/wiki/Quality_management_system
8. p.8
Aligning the TCL QMS with our Corporate QMS
• Roles and responsibilities
• Standard Operating Procedures (SOPs)
• Corrective Action and Preventive Action (CAPA)
• Training
• Feedback
• Management Review (MR)
• Audit
9. p.9
Model 2:
Capability Maturity Model (CMM)
AT A GLANCE
Background
QMS
CMM
CoQ
Elements
Implementation
Final Thoughts
A tool developed by Carnegie-Mellon University
to improve software development.
This tool is widely leveraged as a general
model to aid in improving organizational
business processes.
Source: http://en.wikipedia.org/wiki/Capability_Maturity_Model
10. p.10
CMM Levels
Level 1: Initial
Chaotic
Level 2: Repeatable
Level 3: Well
Defined
Level 4: Managed
Level 5: Optimizing
Use metrics to monitor control of as-is processes.
Systems-view of process performance. Take corrective
action when not within capability.
Ad hoc, undocumented, reactive, ever-changing, unpredictable. Success
is based on heroics of individuals. Individuals are clueless as to issues.
Regulations are not known or ignored.
Focus is on continuously improving process
performance. Statistical measures used to
reduce variation. Robust global development.
Some processes are repeatable, but results are not always predictable.
Processes exist but fail in stressful times. A reactive compliance to
regulations. Reliance on outside resources. Quality exists at project level.
Basic requirements and project management.
SOPs are in place. Review defects. Some improvement over time.
Sporadic efforts and results. Focus on process standardization.
Tailored application of processes. Coordinated communications.
Source: http://en.wikipedia.org/wiki/Capability_Maturity_Model
11. p.11
Model 3: Cost of Quality (CoQ)
AT A GLANCE
Background
QMS
CMM
CoQ
Elements
Implementation
Final Thoughts
Armand V. Feigenbaum defined Cost of Quality
as a means to quantify the total cost of
quality-related efforts and deficiencies.
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Cost of Quality
Prevention Appraisal Internal Failure External Failure
Arise from efforts to
keep defects from
occurring
Arise from detecting
defects
Arise from defects
caught internally and
dealt with by
discarding or
repairing the defects
Arise from defects
that reach customers
Examples:
Training
SOPs
Quality Planning
Product Design
Verification
Examples:
Inspection
Audit
Testing
Examples:
Scrap
Rework
Examples:
Customer complaints
Warranty costs
Good will
Product Service
Product recall
$ $$ $$$ $$$$
Source: http://en.wikipedia.org/wiki/Quality_costs
13. p.13
CoQ in Technical Communications
Prevention Appraisal Internal Failure External Failure
Training
Standard Operating
Procedures
Templates
Scripts
Standards Guide
Style Guide
Training Plan
Design Documents
File naming
conventions
Request Forms
Edit
SME Review
Validation
Trade Trial
Pilot
Linguistic Review
Desk Edit
Proof
Usability Study
Rework
Churn
Reprints
Scrap
Slipped dates
Missed deliverables
How-to-Support calls
Returns
Modifications
Service Bulletins
Product Recall
Sales discontinuance
Product Liability
Loss of reputation
14. p.14
CoQ in Technical Communications
Prevention Appraisal Internal Failure External Failure
- Training
- SOPs
- Templates
- Scripts
- Standards Guide
- Style Guide
- Training Plan
- Design Documents
- File naming
conventions
- Request Forms
- Edit
- SME Review
- Validation
- Trade Trial
- Pilot
- Linguistic Review
- Desk Edit
- Proof
- Usability Study
- Rework
- Churn
- Reprints
- Scrap
- Slipped dates
- Missed Deliverables
- Support calls
- Returns
- Modifications
- Service Bulletins
- Product Recall
- Sales
discontinuance
- Product Liability
- Loss of reputation
15. p.15
Quality Elements in Technical
Communications
• SOP
• Standard or Style Guide
• Template
• Script
• Editing
• Review/Approve
• Validation/Verification
• Doc Training Plan
• Design Document
• Desk Edit
• Linguistic Review
• Training
• Spell Check
• What have we missed?
AT A GLANCE
Background
QMS
CMM
CoQ
Elements
Implementation
Final Thoughts
16. p.16
Implementation
AT A GLANCE
Background
QMS
CMM
CoQ
Elements
Implementation
Final Thoughts
Where do we start?
CMM Level 2
What do we include?
Quality Elements for prevention & appraisal
How do we manage change?
Tuckman’s Model
18. p.18
Tuckman’s Group Development
AT A GLANCE
Background
QMS
CMM
CoQ
Elements
Implementation
Final Thoughts
Source: Bruce W. Tuckman, “Development Sequence in Small Groups,”
Psychological Bulletin, 1955
Forming
StormingNorming
Performing
19. p.19
Group Dynamic During Maturity
Level 1: Initial
Chaotic
Level 2: Repeatable
Level 3: Well
Defined
Level 4: Managed
Level 5: Optimizing
Forming
StormingNorming
Performing
20. p.20
Action Register
TCL QMS Action Plan
Client Satisfaction Graph Quality Metric Graph
Action Who Due Status
1. Get buy in from leadership
2. Communication QMS Vision
3. Establish roles
4. Document SOPs
5. Train on SOPs, QMS, etc.
6. Implement processes for
audit/appraisal, corrective action, &
preventive action
7. Establish measure system
8. Implement improvements
21. p.21
Final Thoughts
AT A GLANCE
Background
QMS
CMM
CoQ
Elements
Implementation
Final Thoughts
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