The document summarizes a presentation on transitioning from manual to automated quality and compliance processes. It discusses defining workflow and automation, aligning the organization, gaining alignment, and return on investment. It provides examples of one company's journey to establish a quality culture, use standard models, implement master data management and capability maturity models, and realize increased sales and reduced working capital through improved quality. The presentation aims to help organizations define their aspirational state and determine a path to transition processes from manual to automated.

1. Global Quality Workflow
The Transition from Manual to Automated
Compliance Processes
American Medical Device Summit
21 September, 2015

2. 1. Definitions of Workflow and Automation
2. Aligning the Corporation
3. How to Gain Alignment
4. Return on Investment
5. A Case Study
6. Q & A
Presentation Topics
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3. Some definitions of “Workflow”
3
The point of view depends upon your perspective.
©2015 Maetrics. All Rights Reserved.
Sample “Google” based search for Workflow definition
The sequence of industrial, administrative, or other processes through which a piece of
work passes from initiation to completion.
(Google top level)
Workflow is the series of activities that is necessary to complete a task. (Searchcio.com)
The flow or amount of work to and from an office, department, or employee.
(Dictionary.com)
Progression of steps (tasks, events, interactions) that comprise a work process, involve
two or more persons, and create or add value to the organization's activities.
(Businessdictionary.com)
A bull---t management word for a process which they don’t understand.
(urbandictionary.com)

4. Some definitions of “Automated”
4
“Wait times are longer than normal – please leave a message.”
©2015 Maetrics. All Rights Reserved.
Sample “Google” based search for “Automated” definition
Convert (a process or facility) to a largely automatic operation. (Google top level)
IT automation is the linking of disparate systems and software in such a way that they
become self-acting or self-regulating. (searchcio.com)
To install automatic procedures, as for manufacturing or servicing; follow or utilize the
principles of automation. (dictionary.com)
Use of email-based software technology to increase the efficiency of a workflow by
improving the coordination of the activities of the people involved. (Business
dictionary.com)
Disembodied voice that answers consumer service questions providing no answers and
plenty of frustration. (urbandictionary.com)

5. Aligning the Corporation
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6. Aligning the Enterprise with Corporate Strategy
6©2015 Maetrics. All Rights Reserved.
Business Architecture: Aligning Organization, Business Processes and IT to
support business strategy
Sub tasks can be grouped into three functions: Specify, Plan and Execute.
Efficient
Customer
Centric
Sustainable
Specify: i.e. What needs to be accomplished, what is a
successful outcome, what is the budget?
► What are the key parameters and metrics?
► What are the product and process specifications?
► What level of risk is acceptable?
- Does everyone have access to, and understand, the specs?
Execute: i.e. How are the processes monitored?
► Can I reliably estimate my completion?
► Can I detect and correct/approve product/process non-conformance?
► Did I meet the operational budget?
- Do I reliably meet the specifications?
Plan: i.e. What has to be done, by when?
► What is my demand/forecast?
► What is the capacity and constraints?
► What level of volatility is manageable?
- Are all business processes/stakeholders aligned?

7. Production Management Systems
The related systems are interdependent and should be developed with
mutual oversight.
Specifications
Management
System
(SMS)
Production
Planning
System
(PPS)
Manufacturing
Execution
System
(MES)
Production
Management
Systems Have
Multiple Parts
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8. “Aspirational State” and How to Get There
8
Start with a clearly articulated, well documented Charter and “future state” vision.
©2015 Maetrics. All Rights Reserved.
What are the attributes of the future state – what capabilities will you have?
Current State:
“War Zone”
Future State:
“Nirvana”
3. Master
Data
2.Standard
Process
models
5. ROI
4. Capability
Maturity
1. Quality
Culture

9. 1. Quality Culture: Management Considerations
Building a Quality Culture is a methodical and stepwise process that takes a
substantial level of effort and commitment.
Colleagues see
quality as a source
of pride and job
satisfaction.
Quality is embedded into
every employee’s mindset
and actions.
Everyone is speaking the
same language of quality.
Campaigns drive quality
initiative into the day-to-day
conversation.
Quality organization is designed,
staffed and in place.
The launch of a sustainable,
effective Quality Culture is a
journey that begins with the
launch of the organization …
… a journey that ends with the strategic
pillar embedded within the mindset and
behaviors of every employee.Launch
Build
Awareness
Alignment on
Quality
Practices
Adoption
Quality
Culture
©2015 Maetrics. All Rights Reserved. 9

10. 2. Standard Model Structure
Maetrics endorses adoption of a “Standard model” organization, process and
technology aligned with business strategy.
 Business operating model alignment: Standard Model components support closer alignment across the
organization from product development to customer service.
 Business process consistency: Common process (e.g. specification management) will support greater
collaboration, a common vocabulary and staff flexibility (e.g. establishment of “Process Champions”).
 Information technology: The current and future investment in IT will equally, and proportionately, support
Quality and Compliance functions.
Organization Process Procedures
IT Apps Materials Costing
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Using standard components to construct a standard business model simplifies strategic decisions.

11. Technology
Standards
Distribute
Capture
Store
Processes
Organization
3. Master Data Management (MDM)
Effective Master Data Management (MDM) enhances the organization’s ability
to fully leverage information technology.
©2015 Maetrics. All Rights Reserved. 11
 Is captured once, on time, accurately, completely, correctly and consistently, thus enabling master data quality;
 Is stored in a way that guarantees integrity and a single place of reference;
 Is made available to those who need it, whenever they need it, both internally and externally.
Master
Data
Management
Locations
Customer
Locations
Item/SKU
Account
Sites
Agreement
Price
List

12. 4. Capability Maturity Models
Meeting increased regulatory expectations
2. Point Solutions,
Some
Workflow
Automation
3. Integration of
Infrastructure
and Enabling
Technologies
4. Integration with
Operational
Systems to Provide
Automated Controls
Monitoring
5. Enterprise Risk
Management and
Automated
Compliance Processes
1. Mixture of Paper
and Procedural
Controls
System Maturity Level
 “Point of Use
Verification”
 Automated
monitoring
triggers CAPA
workflows
 Controlled data
stored in Excel,
Word, etc.
 Hard copy sign-
off
 Product, Object,
Region, Division
specific
procedures
 Best of breed
systems to
address
compliance
 Central
“Groups” to
oversee
change control
 Universal system
access
 “Single Source Of
Truth”
 Doc Mgt, version
control, audit trail,
archiving, etc.
 Business process
definition/workflows/
automation
 Seamless integration
of compliance
processes and
operational systems
at the enterprise level
 “Common
Information Model”
Compliance Maturity Level
12
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13. 5. ROI: Increased Sales
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 A company going from average to good quality/compliance performance sees 3-4% of
increased revenue.
Day-to-day costs
Costs due to non-routine
quality events
Revenue loss due to non-
routine quality events
Total Quality Costs for
Industry
10-14% of revenue
($14-21B)
1-2% of revenues
($1.5-3B)
0.7-1.4% of revenues
($1-2B)
Current
Industry Cost
Capturable
For Industry
$3.5B
$0.75-1.5B
$0.5-B
A study by UCLA showed that companies traded on the NYSE that obtained ISO certification showed better
financial performance than companies that did not.
(Reference: Corbett et al. The Financial Impact of ISO 9000 Certification in the United States. Management
Science. Vol. 51, No. 7, July 2005, pp. 1046-1059.)
Improved sales represent a $4.75 to $6 billion opportunity for the industry.
Investment in quality and compliance = improved financial performance.

14. 5. ROI: Reduced Working Capital
 Quality is considered “non value added” in LEAN and Value Stream mapping, e.g.:
 Elapsed time to resolve non-conformance reports and implement the CAPA
 Elapsed time to review and approve manufacturing record to release product
A case study (Pharmaceutical)
 Client had a high-volume product, with a median manufacturing lead time of 63
days for bulk tablet product:
 Conducted extensive process modelling, material flow and bottleneck analysis
 Theoretical minimum lead time (no “proceed at risk”) was 11 days plus final QA release
 Project goal was to manufacture 10 batches with a median lead time of 30 days
©2015 Maetrics. All Rights Reserved. 14
What is the ROI on quality?
 Result
 First phase of project achieved 45-day median time – identified equipment availability and
QC/QA constraints
 Finding: Delays in resolving NCR plus batch record review caused 15 days delay
 Project was converted to a “right first time” initiative
 Conclusion – Performance improvement must include quality
The project released $24 million in working capital FOR ONE PRODUCT.

15. One Company’s Journey
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16. One Company’s Journey to Automated Quality Workflow
Three key guiding principles:
1. Single source of truth: Are objects, transactions and status consistently
represented across the enterprise? Created once and used many times by many
systems/processes?
2. Point of use/continuous verification: Before, during and after a transaction, do I
know/confirm the compliance status of the materials, method, machine and
“man”power that I am using? Can I avoid exceptions – or, at least, quickly identify
and resolve non exceptions?
3. Paperless operations and Release by no exception: How much data is captured
electronically vs. on paper?
©2015 Maetrics. All Rights Reserved. 16
Am I ready for the increasing regulatory expectations for non-conformance, CAPA, APR and Complaints?

17. ISA S-95 based Application Architecture
Will need to be well defined with governance rules applied
Level 3
Level 2
E
A
I
Product
definition
management
Discrepancy
management
Enterprise
asset
management
Manufacturing
execution
Warehouse
management
Laboratory
information
management
Calibration
management
Finite
scheduling
GMP
document
management
PI plant
data history
PI DCS
data history
DCS
MQA
auto-close
Finance Procure to pay Order to cash
Manufacturing,
QA and inventory
Supply chain
planning
Weigh/
dispense
Human
resources
Process
development
In-line
chromato-
graphy
Level 4
(Possibly in future
ERP footprint)
Batch release
ERP
EAM
DCS
PDM
MES
Learning
management
Batch history data
server
Building
automation
system
MQA
online
Batch
manager
Off-line
chromato-
graphy
Corporate
governance –
enterprise level
systems
Plant autonomy
– process /
operation level
systems
Corporate standards for
data, integration, and
application arch.
Common
Information
Model

18. Product Definition Management
Re-usable and supports specification provenance (“as specified” or “as filed
with HA”).
Process
Development
ERP
EAM
MES
LIMS
DCS
► Item master
► Bill of “manpower”
► Bill of “machine”
► Bill of “materials”
► Bill of “methods”
► Documentation (SOPs,
MSDS, etc.)
Equipment , maintenance and
calibration procedures
Technology
transfer
Item master, bill of material, routing
Recipe, instructions
Bill of resources
Mfg. Process instructions,
Bill of resources
Specifications, test methods,
bill of resources
Master bx.
records
Product Definition
Management
18
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19. Product Definition Management – data: Con’t
Re-usable and supports specification provenance
PDM Will Manage Product Information:
 Deliver current method to MES, DCS, etc.
 Maintain congruency with submissions
 Facilitate technology transfer
 Improve change control
 Provenance of batch record content
©2015 Maetrics. All Rights Reserved. 19
Batch Record Restructuring:
 Define unit operations
 How many ways can you “mix” (combine,
stir, blend, agitate, etc.)?
 Parse verbiage between Policies, Directives,
SOPs and Work Instructions
 How to set up a mixer is in an SOP.
 “Mix at 200 RPM for 20 minutes” is in a
work instruction or recipe.
 Structure documentation to be pre-digested
for conversion into target MES
 Use parameter substitution
 (For product A) mix at $speed1 rpm for
$time minutes

20. Process Compliance:
Supports Point of use Verification (POV) and Release by non-exception
Finite Scheduling
Equipment
Logs
Scales DCS LIMS
Learning
Management
EDMSDMS
Material
Management
Weights
Allocated
materials
Equipment
usage
Batch recordCAPA status Record CAPA
Process data and
trend data
Control recipe
tags / attributes
Test
results
Log
sample
Operator
qualifications
Execution process
Electronic
historian
records
Production
actuals
Transactional information
Maintenance
Management
Calibration and
cleaning status
Produced
materials
Production
order
Recipe
Management
Master
recipe
Show SOP
20
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21. 1. Alignment of business process to corporate strategy
2. Define the aspirational state
3. Determine the path to your future state
4. Build the future state with standard components
5. Quality is a business benefit with strong ROI
Questions??
Wrap up and Questions?
21©2015 Maetrics. All Rights Reserved.

22. ©2015 Maetrics. All Rights Reserved.
Thank You!
22
The contents of this presentation are copyright ©2015 Maetrics. All rights reserved.
This presentation contains information in summary form and is intended for general
guidance only. It is not intended to be a substitute for detailed research or the
exercise of professional judgment. Maetrics LLC cannot accept responsibility for loss
occasioned to any person, firm, company or corporation acting or refraining from
action as a result of any material in this publication. On any specific matter, reference
should be made to the appropriate professional advisor.