workshop on lean & 6 sigma principles for labs in ...©2011 waters corporation 1 workshop on...

©2011 Waters Corporation 1

Workshop on

Lean & 6 Sigma Principles for Labs in

Regulated Development & QC using

Informatics Case Studies

John Beary

Nordic User Training 2013


Workshop Description

In this workshop, the importance of Informatics solutions for

laboratory related Lean Six Sigma projects will be discussed

We will explore how our Customers have leveraged Waters'

Laboratory Informatics solutions to support these initiatives by:

— Eliminating waste and defects

— Reducing variability

— Improving quality


Pharma Continues to Embrace Operational Excellence as Profitability is Pressured


Roche - Area of Impact: Laboratories

Champaneria, Nitin J., Lean Six Sigma and Operational Excellence at Roche, WCBF’s Lean & Six Sigma Summit – Chicago, June 2009 http://www.sixsigmazone.com/presentations/lean-six-sigma-and-operational-excellance-at-roche


Roche – List of Selected Projects

Champaneria, Nitin J., Lean Six Sigma and Operational Excellence at Roche, WCBF’s Lean & Six Sigma Summit – Chicago, June 2009 http://www.sixsigmazone.com/presentations/lean-six-sigma-and-operational-excellance-at-roche


Strategies to Increase Efficiency and Quality

Lean Increasing efficiency by eliminating unnecessary steps within a process and reducing waste.

Six Sigma Improve processes by eliminating defects and reducing variability.


Lean & Six Sigma

Lean Management

Eliminate non-value added activities (waste)

Reduce complexity

Improve flow

Improve Speed

Six Sigma

Reduce variation

Reduce defects

Reduce Cost of Poor Quality (COPQ)

Improve Quality


Identifying Value and Non-Value Added Activities

An Overview of Process Excellence and Lean Thinking at Johnson & Johnson, Edwin Nau, May 2007 http://www.ispe.org/galleries/midwest-files/ISPE-NauPresentatio98C9BA.pdf


Business Demands

Laboratory Demands

CEO CIO

Scientists Project

Managers

You


An Overview of Lean Six Sigma

Lean Eliminate unnecessary, non-value added steps within a process. Principles of “flow” and “pull”. Makes sure we are working on the right activities

Six Sigma Improve processes by eliminating defects and reducing variability


Defect/Rework Not doing or making it right first time

Lean is the Elimination of Waste…

Motion Any movement that does not added value

Transportation Any non-essential transport is waste

Inventory Any more than the minimum to get the job done

Waiting Waiting on parts, or for a machine to finish cycle

Processing Inefficiency due to poor tool or design

Overproduction Producing too much,

or too soon

7 Kinds of Waste

…waste elimination can be applied to any process


Laboratory-Based Workflows and Systems

Harmonization & Standardization

Centralization

Reduce the Total Number of Software Applications

Software Integration and Interoperability

Improve Laboratory Efficiencies

Lower Total Cost of Ownership

Removing WASTE, VARIABILITY, and RISK


QC Workflow Analysis

Worklist Creation

Test Execution

Complete SOP Worksheet

Certificate of Analysis Creation

Select SOP

Sampling From sampling instruction to

certificate of analysis creation, where are the largest

opportunities to minimize waste and variability?


Situational Analysis: Identifying Potential Areas of Improvement


Potential Areas of Improvement: Workflow Optimization

Examples

— Analysis timelines

— Customized text and calculations

— Processing methods

— Asset utilization


Analysis Timelines

Use of e-signatures within Empower allows detailed analysis of

result workflow through the lab

Metrics that can be calculated:

— First injection to first result processing

— First result processing to last result generation

— Last result generation to first sign off (level 1)

— First sign off to second sign off (level 2 review)

— Total time

— All metrics measured in days


Discovering Waste and Variability in Analysis Timelines

Project 1

Project 2

Project 3

Project 4

Project 5

Project 6

Project 7

Project 8

Project 9

Project 10

Project 1

Project 2

Project 3

Project 4

Project 5

Project 6

Project 7

Project 8

Project 9

Project 10


Custom Text and Calculations

Text fields (enumerated custom fields)

— Provide consistent format and searchability using drop-down lists

Calculated fields

— Perform custom calculations

such as percent purity without relying

on external calculations or specialized

software programs


Optimize Use of Custom Fields

Project A

Project B

Project C

Project D

Project E

Project F

Project G

Project H

Project I

Project J

Project K

Project L

Project M

Project N

Project P


Processing Method Optimization

Automated processing preferred versus manual integration

— Saves time

— Provides better result integrity

Review number of results per channel

Review percentage of results requiring manual integration


Asset Management

Asset utilization within the laboratory

— Specifically those assets controlled by Empower 3

o HPLC

o GC

— Is asset use optimized to the workload?

— Can asset servicing be conducted without impacting lab

productivity?


Opportunities with Asset Utilization


Minimizing Waste with Asset Utilization


Instrument/User ‘Flexibility’


Defect/Rework Incorrect data entry, manual re-integration, incorrect calculations, outdated SOP’s, regenerating data

Motion Looking for data and information, re-entering data, filing hardcopies, document archiving

Transportation Movement of files and documents from one location to another, storage of intermediaries waiting for approvals

Inventory Files and documents awaiting to be processed, material queued for release, documents awaiting signature

Waiting Waiting for the next step, system downtime, hardcopy retrieval, audit delays, review delays, approval delays

Processing Information sent automatically even when not required, printing documents before they are required, spreadsheet data calculations

Overproduction Too much paperwork, excessive lead time from approval delays

7 Kinds of Waste

…Waters Informatics can impact these

Lean is the Elimination of Waste…


Case Study Example

QC & Manufacturing Organization


Consequences of Delayed Certificate of Analysis

Limited shelf life

— A 15 day COA delay represents 17% of a 90 day shelf life for a

pharmaceutical product

Late/non-shipment

— May translate into millions of dollars of lost revenue per batch

— May allow competitors to build market share with similar products


Strategic Need: Making the Manufacturing Process More Efficient

VP of Operations:: Make a More Efficient Product Manufacturing Process


Strategy for Improving Operational Efficiency

Lean Waste Elimination

Workflow Improvement

Cycle Time Reduction


Informatics Implementation Steps Used to Streamline Certificate of Analysis Process

1

• Standardize Chromatography Data System (CDS)

2 • Standardize Data Management

3

• Implement Electronic SOP Documentation and Workflow System


Standardize Testing Equipment on One Chromatography Data System


Operational Excellence: Advantages of a Common CDS Platform

Standardizes data format

— Exchange of information easier

— Reduces time for review and sign-off

Reduces training effort

— Training required for only 1 software package

Improves compliance

— Relational database provides better traceability

Promotes collaboration

— Easier sharing of methods

— Data review from different geographies possible


Empower Enables CDS Standardization by Supporting Multi-Instrument Vendor Control

http://www.ssi.shimadzu.com/../index.cfm

http://www.hitachi.us/index.html

http://www.teledynetekmar.com/


Standardized Chromatography Data System Streamlines Method Validation


Business Intelligence for a Standardized CDS

Empower Driven Services


Add LIMS to Manage COA and Use ERP to Manager Orders


OpEx: Advantages of Integrating ERP and LIMS Solutions

Automates testing requests

— Issues QC test requests after receiving request from SAP

— Generates sample worklists

Single location to store testing results

— QC test results stored within single LIMS from regional

Empower systems

— COA stored in LIMS


Centrally Store Laboratory Data to Automate COA Generation



Standardized Lab Data Management

Focus on Science and Testing

An Automated Certificate of Analysis

Process


Centralized Data Storage Enables the Use of Intelligent Forms


Combine SOP and Data Entry by Using Electronic SOP Forms

SOP

Data Entry

Stock No. 123456

Compound Source Exp Desired (mg) Actual (mg)

a: Diphenhydramine VMR 22-Nov-07 40 23.13

b: Pseudoepherine HCL Bayer 11-Jan-08 600 6.72

c: Dextromethorphan HBr BASF 10-Feb-08 200 24.16

Table Continued. Batch No.

a: Diphenhydramine DIP-003

b: Pseudoepherine HCL PSD-02

c: Dextromethorphan HBr Dextromethorphan Hbr39398.8115751157

Compound Source Exp Desired (mL) Actual (mL)

H2O-01 Waters 10-Feb-08 50 49.98

Acceptable (Y/N)Conc (mg/mL) Total (mg)

Std. A N 0.05 54.01

Balance ID No. Cal/Qual Date

SrN-11679-B4 4-Nov-07

Step 2: Add 50 mL of purified WaterDextromethorphan HBr

34 Maple Street, Milford MA 01757

Phone: 1-800-252-4752

Fax: 1-508-482-2004

Stock Preparation

Confidential.

Step 1: Weigh the following into a clean dry 100 mL class "A"

volumetric flask.

Step 3: Add purified Water to volumetric flask bringing solvent level

to 100 mL.

Note: Swirl (sonicate if necessary) to dissolve completely.

Standard Details:

Balance Details:


An Electronic SOP Form Can Integrate with ...


<CR> 9.876 unit mg 09/08/2008 wli4345a tare y<CR><LF>

Direct Interface with Balances and pH Meters Reduces Transcription Errors

Stock No. 123456

Compound Source Exp Desired (mg) Actual (mg)

a: Diphenhydramine VMR 22-Nov-07 40 23.13

b: Pseudoepherine HCL Bayer 11-Jan-08 600 6.72

c: Dextromethorphan HBr BASF 10-Feb-08 200 24.16

Table Continued. Batch No.

a: Diphenhydramine DIP-003

b: Pseudoepherine HCL PSD-02

c: Dextromethorphan HBr Dextromethorphan Hbr39398.8115751157

Compound Source Exp Desired (mL) Actual (mL)

H2O-01 Waters 10-Feb-08 50 49.98

Acceptable (Y/N)Conc (mg/mL) Total (mg)

Std. A N 0.05 54.01

Balance ID No. Cal/Qual Date

SrN-11679-B4 4-Nov-07

Step 2: Add 50 mL of purified WaterDextromethorphan HBr

34 Maple Street, Milford MA 01757

Phone: 1-800-252-4752

Fax: 1-508-482-2004

Stock Preparation

Confidential.

Step 1: Weigh the following into a clean dry 100 mL class "A"

volumetric flask.

Step 3: Add purified Water to volumetric flask bringing solvent level

to 100 mL.

Note: Swirl (sonicate if necessary) to dissolve completely.

Standard Details:

Balance Details:

<CR> 9.876 unit mg 09/08/2008 wli4345a tare y<CR><LF> 9.876 mg

9.876 mg


Example of an Intelligent SOP Form

Chemical Inventory Interface

Auto Calculations

Fit-for-use Interface

Balance Interface

Error Proofing


Operational Excellence: Advantages of Intelligent Forms

Reduces errors

— Standardizes Data Input and Performs Error Proofing (~0%)

— Reduces Transcription Errors by directly interfacing with other data

sources (~ 0%)

Improves data review and regulatory compliance

— Procedure documenting (up to ~80% faster)

— Easy Review of Centralized Results (~50% faster)

— Compliant-Ready Solution

Improves quality

— Management has immediate access to data

— Promotes collaboration between teams


Op Ex: Advantages of a Standardized, Unified Informatics Solution

Laboratory data from different systems captured into a common data format using Waters NuGenesis SDMS

Data originating from different geographies

— Captured and cataloged in a common format

Streamlined workflows and cycle-times

— Reduced wasted efforts reduce operational costs

Management has better visibility to the big picture

— Identify problems earlier

Acts as a feeder system

— Electronic COA, eCTD submission process, LIMS, eNotebooks,


Summary

Science is science

— The rapid organized storage of information is critical to all

organizations—QC/QA, R&D, etc.

— The ability to find and reuse information is a necessity in today’s rapid

market evolution

A centralized SDMS provides standardized data management

— Improves laboratory productivity

— Centralizes all data into one location and improves compliance

— Acts as a data integrator and connector for all scientific information—

certificate of analysis, eCTD submissions, and electronic laboratory

notebooks

A standardized CDS platform

— Provides standardized data format, reduces training effort, improves

compliance and promotes collaboration

workshop on lean & 6 sigma principles for labs in ...©2011 waters corporation 1 workshop on...

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