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

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”

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)

Some definitions of “Automated”

4

“Wait times are longer than normal – please leave a message.”


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)

Aligning the Corporation


Aligning the Enterprise with Corporate Strategy


Business Architecture: Aligning Organization, Business Processes and IT to support business strategy

Sub tasks can be grouped into three functions: Specify, Plan and Execute.

Effi

cien

t

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?

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

8

Start with a clearly articulated, well documented Charter and “future state” vision.


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 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


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


Using standard components to construct a standard business model simplifies strategic decisions.

Tech

no

log

y Stan

dard

s

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.


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

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


5. ROI: Increased Sales


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.

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


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.

One Company’s Journey


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?


Am I ready for the increasing regulatory expectations for non-conformance, CAPA, APR and Complaints?

ISA S-95 based Application Architecture

Will need to be well defined with governance rules applied

Level 3

Level 2

EAI

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

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


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


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

Process Compliance:

Supports Point of use Verification (POV) and Release by non-exception

Finite Scheduling Equipment

Logs

Scales DCS LIMS Learning

Management

EDMS DMS Material

Management

Weights

Allocated materials

Equipment usage

Batch record CAPA 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


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?



Thank You!

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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.

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

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