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Global Quality Workflow
The Transition from Manual to Automated
Compliance Processes
American Medical Device Summit
21 Sep...
1. Definitions of Workflow and Automation
2. Aligning the Corporation
3. How to Gain Alignment
4. Return on Investment
5. ...
Some definitions of “Workflow”
3
The point of view depends upon your perspective.
©2015 Maetrics. All Rights Reserved.
Sam...
Some definitions of “Automated”
4
“Wait times are longer than normal – please leave a message.”
©2015 Maetrics. All Rights...
Aligning the Corporation
5©2015 Maetrics. All Rights Reserved.
Aligning the Enterprise with Corporate Strategy
6©2015 Maetrics. All Rights Reserved.
Business Architecture: Aligning Orga...
Production Management Systems
The related systems are interdependent and should be developed with
mutual oversight.
Specif...
“Aspirational State” and How to Get There
8
Start with a clearly articulated, well documented Charter and “future state” v...
1. Quality Culture: Management Considerations
Building a Quality Culture is a methodical and stepwise process that takes a...
2. Standard Model Structure
Maetrics endorses adoption of a “Standard model” organization, process and
technology aligned ...
Technology
Standards
Distribute
Capture
Store
Processes
Organization
3. Master Data Management (MDM)
Effective Master Data...
4. Capability Maturity Models
Meeting increased regulatory expectations
2. Point Solutions,
Some
Workflow
Automation
3. In...
5. ROI: Increased Sales
©2015 Maetrics. All Rights Reserved. 13
 A company going from average to good quality/compliance ...
5. ROI: Reduced Working Capital
 Quality is considered “non value added” in LEAN and Value Stream mapping, e.g.:
 Elapse...
One Company’s Journey
15©2015 Maetrics. All Rights Reserved.
One Company’s Journey to Automated Quality Workflow
Three key guiding principles:
1. Single source of truth: Are objects, ...
ISA S-95 based Application Architecture
Will need to be well defined with governance rules applied
Level 3
Level 2
E
A
I
P...
Product Definition Management
Re-usable and supports specification provenance (“as specified” or “as filed
with HA”).
Proc...
Product Definition Management – data: Con’t
Re-usable and supports specification provenance
PDM Will Manage Product Inform...
Process Compliance:
Supports Point of use Verification (POV) and Release by non-exception
Finite Scheduling
Equipment
Logs...
1. Alignment of business process to corporate strategy
2. Define the aspirational state
3. Determine the path to your futu...
©2015 Maetrics. All Rights Reserved.
Thank You!
22
The contents of this presentation are copyright ©2015 Maetrics. All rig...
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Global Quality Workflow, The Transition from Manual to Automated Compliance Processes

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Norm Rabin's American Medical Device Summit deck on the transition from manual to automated compliance processes.

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Global Quality Workflow, The Transition from Manual to Automated Compliance Processes

  1. 1. Global Quality Workflow The Transition from Manual to Automated Compliance Processes American Medical Device Summit 21 September, 2015
  2. 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 2©2015 Maetrics. All Rights Reserved.
  3. 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. 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. 5. Aligning the Corporation 5©2015 Maetrics. All Rights Reserved.
  6. 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. 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 ©2015 Maetrics. All Rights Reserved. 7
  8. 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. 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. 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 10©2015 Maetrics. All Rights Reserved. Using standard components to construct a standard business model simplifies strategic decisions.
  11. 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. 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 ©2015 Maetrics. All Rights Reserved.
  13. 13. 5. ROI: Increased Sales ©2015 Maetrics. All Rights Reserved. 13  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. 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. 15. One Company’s Journey 15©2015 Maetrics. All Rights Reserved.
  16. 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. 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. 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 ©2015 Maetrics. All Rights Reserved.
  19. 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. 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 ©2015 Maetrics. All Rights Reserved.
  21. 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. 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.

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