Squaring the TriangleSquaring the Triangle

The Challenges to Operational Excellence in a Large Scale Multiproduct Facility

Chris MullenABC5000 Production Manager

Manufacturing – From Fertilisers to BiotechManufacturing – From Fertilisers to Biotech

$Millions > 1M tons

TIME

VALUE QUANTITY

Performance ObjectivesPerformance Objectives

• Performance Objectives

– Quality

– Cost

– Dependability

– Speed

– Flexibility

Time

Change

Compliance

The Performance TriangleThe Performance Triangle

TimeChange

Compliance

Manufacturing

ComplianceCompliance

• Emphasis on being “technically excellent”– Biotech journey– Regulator pressure

People make mistakes

Increasing cost of mistakes

Missing a TrickMissing a Trick

Nuclear / Chemical Industry

• Safety orientated• Risk averse• Numerous tools

– Ergonomics– Behaviours– Operability

Biotech Industry

• Quality orientated• Risk taking?• Lack of

understanding & application

Some Ergonomics ExamplesSome Ergonomics Examples

Legacy lab equipment Lack of error proofing

Fermentation Control System

Beta Ultrafiltration RigUnicorn Based

Systems

Improving Compliance ManagementImproving Compliance Management

1. Design & Engineering

2. Admin Systems & Control

3. Behaviours 4. Attitudes

• Mindset change required• Balance delivery & capital cost against cost of failure• Build error proofing into design

Change in a Manufacturing EnvironmentChange in a Manufacturing Environment

Every day is a new adventure!

Planned Continuous Improvement

Compliance vs. ChangeCompliance vs. Change

Where are our techs and where are our processes/procedures?

Input

Skill

Rule

Knowledge

Action

Rehearsed routines; patterns; A then B

Automatic, familiar, well practised

Novel, no existing rules

Low confidence & certainty; Controlled processing

High confidence & certainty; Automaticity

Error Rate

1 in 10

1 in 10,000

Conscious Thought

Barriers to ComplianceBarriers to Compliance

• Short campaign length

• Differences between

processes

• Change of procedures

• Size of the documents

and amount of entries

• Difficult plant/operator

interfaces

• Improve mental picture

• Establish ‘Avecia Way’

• Lockdown of process

• New streamlined document system

• Improve ergonomics

CurrentBMRScope

New Documentation system New Documentation system

Equipment SpecificWI Lite

Product SpecificRecipe

Batch SpecificBatch Records

Site SpecificSOP Lite

Site SpecificPolicy Lite

The only customer reviewed

documents

Guidelines

Performing a Unit Operation in ABC5000Performing a Unit Operation in ABC5000

Current System New Document System

Documents Pre-approval Documents Pre-approval

What to do / use BMRs, SOPs, Temporary instructions

Avecia and Customer Recipes Avecia and Customer

How to do it BMRs, SOPs, Temporary instructions

Avecia and Customer Work Instructions

Avecia

What to record BMRs, Temporary Instructions

Avecia and Customer Batch Records Avecia

Time or the lack ofTime or the lack of

• Customer– Clinical programmes to hit

• CMO– Production schedule to hit

MAKE MONEY

• Increased project timelines– Lockdowns

– ‘Water’ batches

– Enhanced training

• Offset by improving RFT

Continuing the AdventureContinuing the Adventure

• Technically excellent is not enough– Apply SHE analogy– Mindset change

• Minimise change– Project discipline– Standardise working

• Delivery– Balance timelines against RFT