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.

1. © 2011, Carestream Health
Building Quality
Into Your
Technical
Communications
Department
Spectrum
April 1, 2011

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

3. p.3
Background:
Carestream Health, Inc.
 Health imaging hardware, software, and
services
 Global sales and service
 Regulated products
 Product development sites around the
world

4. p.4
Background:
Technical Communication and Localization (TCL)
Customers
Employees
Partners
Create
Content
Localize Deploy
Manage Content

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.

12. p.12
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

17. p.17
Quality Elements Mapped into TCL Process
Create Content Localize Deploy
Plan
Manage Content
Quality

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
?!

22. p.22
Questions?
John Lukes
John.Lukes@carestream.com
Amy Friend
Amy.Friend@carestream.com