Embed Size (px)
Citation preview
PRESENTATION TO MANUFACTURING
TECHNOLOGIES MEMBER INTEREST GROUP (MIG)
23 JANUARY 2014
FACILITY DEVELOPMENT AND DELIVERYPRAKASH DAVDA AND GRAHAM SEX
The Austin Company
CONTENTS | AGENDA
Introduction
Manufacturing (our experience) -
Critical design considerations:
o Highly Regulated
o Clean & Hygienic environmental
conditions
o Clearly Defined Flows
o Good Manufacturing Practise
(GMP)
o Lean Design Principles
o Future Proofing
How this approach benefits Food
related projects
o Recent Experience and examples
Recipe for Successful Project Approach
and Delivery
Value Gained by the Process
Results - Client Feedback / Comments
The Austin Company
INTRODUCTION
How our experience in the Pharmaceutical sector can benefit Food Manufacturing
Critical design considerations:
Highly regulated (MHRA/FDA). Often
in excess of the Food Industry (e.g.
Intravenous drug delivery)
Clean & Hygienic environmental
conditions
o Clean Room Environments (ISO
standards)
o HVAC, Finishes, Materials & Details
Clearly Defined Flows
o Process, People, Materials, Waste,
Equipment
o To reduce risk of cross-
contamination / People change
protocols
Good Manufacturing Practise (GMP)
Lean Design Principles (to improve
efficiencies)
Future Proofing
The Austin Company
HIGHLY REGULATED
The Austin Company
HIGHLY REGULATED
Incl MHRA/FDA.
ISO Standards
Filtration
Room Pressures
Localised Environment
o Filling
o Cleaning
o Isolators
o Safety Cabinets
Good Manufacturing Practise (GMP)
The Austin Company
CLEAN & HYGIENIC ENVIRONMENTAL CONDITIONS
HEPA Filtration
Critical Temperature & Humidity
Containing Smells & Odours
Room Finishes & Materials
Detailing
Cleaning Regimes
Maintenance & Access (Internal / External to Critical Environments)
Vector Control
The Austin Company
CLEAN & HYGIENIC ENVIRONMENTAL CONDITIONS
The Austin Company
CLEARLY DEFINED FLOWS (SPATIAL ORGANISATION)
Process Flows
o Operational requirements.
Separation of Activities
People Flows
o From Entering the Facility to
Leaving
o Hygiene Procedures / Change
Protocols
o Minimise risk of cross
contamination
o Minimise risk to Health & Safety
Material Flows
o Separate from People Flows
o Separate materials “in” and
Finished Product “out”
o Buffering / WIP
Waste Flows
o Separation & Segregation,
Recyclable
Equipment Flows “in” & “out” -
Storage / Parts / Maintenance
The Austin Company
CLEARLY DEFINED FLOWS (SPATIAL ORGANISATION)
Proposed Process (incl. People , Material & Waste Flows)
The Austin Company
CLEARLY DEFINED FLOWS (SPATIAL ORGANISATION)
Proposed People Flow
Street to F Class Area
Class Area F
Class Area B
Class Area C
The Austin Company
GOOD MANUFACTURING PRACTISE (GMP)
GMP Certification schemes provide assurances to consumers of the safety and quality of
Pharmaceutical Products.
GMP is an important enhancement to efficiency, minimising waste and improving safety
management systems
o increasing customers’ confidence in the production of safe and high quality Products
The same is true with Food manufacturing:
The Austin Company
GOOD MANUFACTURING PRACTISE (GMP)
GMP Compliance ensures :
o integrity of Food manufacturing processes
o compliance with Food safety regulations.
o common sense approach to sanitary and processing requirements to Food
manufacturing
The Food Manufacturing Industry has implemented GMP certification schemes to
developed and implement quality and safety management systems, incl:
o Hazard analysis and critical control points (HACCP)
o ISO 9000/9001 Quality Management (including ISO 22000 Food Safety System
Certification derived for the Food Industry)
o Safe Quality Food certification (SQF)
Customer Specific Standards
The Austin Company
GOOD MANUFACTURING PRACTISE (GMP)
The Austin Company
LEAN DESIGN PRINCIPLES
Lean Design Principles are becoming more common place as part of the overall facility Design
and Management process.
Lean Six Sigma is a managerial
concept combining Lean and Six Sigma.
o Lean - a production practice that
considers the expenditure of
resources for any goal other than
the creation of value for the end
customer, to be wasteful, and thus
a target for elimination
o Six Sigma - (further development
of 5 Sigma originally developed in
the 1990`s) is a set of techniques
and tools for process improvement
– (Sort, Stabilise, Shine, Standardise,
Sustain, Safety)
Lean Six Sigma - Combines Lean
design principles with Six Sigma
techniques ( first developed in 2002 )
aims to eliminate eight kinds of waste:
o Defects, Over-production, Waiting,
Non-Utilised Talent, Transportation,
Inventory, Motion, Extra-Processing
The Austin Company
LEAN DESIGN – TYPICAL PROCESS
VISION
Business
Customer
Productivity
PROCESS
Batches
Sequencing
Testing
MODULE
Opt size / No off
Flexibility
Technology
FLOWS
People
Material
Waste
ENVIRONMENT
Interactive
Transparency
Ergonomics
OPERATION
6 Sigma
Storage / JIT
Maintainability
The Austin Company
FUTURE PROOFING
When developing requirements (and then the design), of any new facility, the future needs of
the Business should be considered where ever possible. Such design considerations should
include:
Varying Business Demands (Through-put / Products)
Future Expansion
Flexibility v. Adaptability
Product Development
Developments in Equipment / Technology
Automation
Innovation
The Austin Company
FUTURE PROOFING
The Austin Company
HOW THIS BENEFITS FOOD RELATED PROJECTS:
Examples of how our experience has benefitted recent Food related projects:
Cadbury - Innovation Kitchen, GMP Module and QC Facility
British Bakels – Manufacturing Facility
Barry Callebaut – Food Academy and Demonstration Kitchens
2 Sisters Food Group – QC Facility
The Austin Company
CADBURY – INNOVATION KITCHEN, GMP MODULE & QC FACILITY
Material and Equipment IN
People IN/OUT
Waste OUT
Fire Exits
The Austin Company
CADBURY - INNOVATION KITCHEN, GMP MODULE & QC FACILITY
The Austin Company
BRITISH BAKELS MANUFACTURING FACILITY
PHASE 4
PHASE 1
PHASE 3
PHASE 2
Future proofing
The Austin Company
BRITISH BAKELS MANUFACTURING FACILITY
New wet factory
The Austin Company
BARRY CALLEBAUT FOOD ACADEMY
Academy visitor Academy
employee
Factory visitor Factory
employee
The Austin Company
BARRY CALLEBAUT FOOD ACADEMY
The Austin Company
2 SISTERS FOOD GROUP – QC FACILITY
Equipment Flow
Material Flow
People Flow
The Austin Company
2 SISTERS FOOD GROUP – QC FACILITY
The Austin Company
SUCCESSFUL PROJECT APPROACH AND DELIVERY
Concept Design
RIBA stages 1 – 2 (A –C)
Step 1A
• Receive or assist in
developing Brief
• Analyse Data
• Apply Standards
• Identify Options
• Review Pre-Construction
Information
• Establish Parameters
(TCQ)
• Prepare Concept Design
• Prepare Programme
• Prepare Budget (±25%)
• Present Report
Preliminary Design
RIBA stage 3 (D)
Step 1B
Detailed Design and Management of Construction
RIBA stages 3 – 7 (E to L)
Step 2
• Review Concept Design
• Review Parameters
• Consult with Authorities
• Develop Design on Agreed
Option
• Develop Specification
• Develop Programme
• Develop Quality Plan
• CDM / Pre-Construction
information
• Develop Cost Plan (±10%)
• Prepare Planning Application
• Prepare Preliminary Design
• Present Report
• Review Preliminary Design
• CDM Coordination including Construction Phase Plan
• Finalise Detailed Design
• Issue Building Regulations Application
• Finalise Work Packages
• Obtain Agreement
• Procure Work Packages
• Implement Construction
• Manage Site Works
• Record Progress
• Provide Design and Engineering Support
• Value Subcontractors Payments
• Commissioning
• Record Documentation
• Validation of Processes (DQ. IQ & OQ)
• Prepare H&S File / O&M Manuals
• Training
• Handover Facility
four to six weeks eight to ten weeks
The Austin Company
VALUE GAINED BY THE PROCESS
A Robust & Structured design approach as developed for the Pharma Industry can bring
Added Value to the Food and other Industries, but not at Additional Cost!
At the start of the design process, clear objectives are set covering Budgets, Time Scales,
Quality, as well as Business and Operational requirements. A robust design approach brings
additional benefits, often when meeting agreed minimum criteria – these can include:
Reduced “design & site time” and
thereby minimising disruption &
inconvenience to on-going operations
Operational Efficiencies on many levels
(i.e. lean Six Sigma approach)
Improved Regulatory Compliance
Reduced Wastage (e.g. through
reduced risk from cross-
contamination)
Reduced Risk to Health & Safety (and
therefore productivity)
Future Proofing allows easier &
quicker response to changing business
needs
Designing with Maintenance in mind
reduces downtime & maximises
productivity
Quicker delivery
The Austin Company
RESULTS - CLIENT FEEDBACK / COMMENTS
Cadbury - QC facility
“Austin`s process allowed Cadbury to obtain buy-in from all stakeholders and project budgets
approved quicker. The facility was delivered 95% to the original agreed concept, minimising
variations and associated impact to time & cost. Delivered on time & to budget, with all
stakeholders fully satisfied” – Quality Adviser, Cadbury
British Bakels Manufacturing Facility
“Expansion made much easier as the 1st phase considered the future 8 phases over 15 – 20
years. Although this was at a high level future phases have progressed pretty close to plans
developed during Phase 1 in the 1980`s” – Managing Director, British Bakels
The Austin Company
RESULTS - CLIENT FEEDBACK / COMMENTS
Barry Callebaut Food Academy and Demonstration Kitchens
“Approach to design undertaken by Austin created rigour, concluding with the best available
solution. Far more robust & rigorous than any other similar academy around the world” – Director
Gourmet UK & Ireland.
2 Sisters Food Group – QC Facility
1. “From initial concept to final design and execution, we found Austins the key to the delivery of a
successful project in every respect” – MD, Amber Real Estate Investments Ltd
2. “I am pleased that we selected Austins for the work. Their multi-disciplinary team ensured the
resolution of difficult challenges and completion of all targets on time” – Senior Microbiologist/Project
User representative, 2SFG.
3.”The finished product has created so much efficiency in flows, i.e. product in / product out, that
were not envisaged” –Laboratory Services Manager, 2 Sisters Technical Services.
