global quality workflow, the transition from manual to automated compliance processes

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

    American Medical Device Summit

    21 September, 2015

  • 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.

  • Some definitions of Workflow


    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. ( The flow or amount of work to and from an office, department, or employee. ( 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. ( A bull---t management word for a process which they dont understand. (

  • Some definitions of Automated


    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. ( To install automatic procedures, as for manufacturing or servicing; follow or utilize the principles of automation. ( 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 Disembodied voice that answers consumer service questions providing no answers and plenty of frustration. (

  • Aligning the Corporation

    5 2015 Maetrics. All Rights Reserved.

  • 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.




    Customer Centric


    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?

  • 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

  • Aspirational State and How to Get There


    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

  • 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 employees 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


    Quality Culture

    2015 Maetrics. All Rights Reserved. 9

  • 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.

  • Tech



    y Stand







    3. Master Data Management (MDM) Effective Master Data Management (MDM) enhances the organizations 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









    Price List

  • 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




    triggers CAPA


    Controlled data stored in Excel, Word, etc.

    Hard copy sign-off

    Product, Object, Region, Division specific procedures

    Best of breed

    systems to




    Groups to


    change control

    Universal system


    Single Source Of


    Doc Mgt, version

    control, audit trail,

    archiving, etc.

    Business process



    Seamless integration

    of compliance

    processes and

    operational systems

    at the enterprise level


    Information Model

    Compliance Maturity Level

    12 2015 Maetrics. All Rights Reserved.

  • 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




    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.

  • 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


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