ISPE INDONESIA – WORKSHOP

PROCESS VALIDATION
INTRODUCTION

Pierre Winnepenninckx – No deviation Pte. Ltd.

Joon Ng Leong – No deviation Pte. Ltd

21 & 22 November 2018

PROCESS VALIDATION IN
AFTER EQUIPMENT
QUALIFICATION
Begin with the end in mind

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ICH Q10 – Pharmaceutical Quality System - Objectives

Achieve product realisation

Establish and Maintain a State of Control

Facilitate Continual Improvement

©2018

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What is Lean?

1. Creating value for the customer

2. Designing organisational processes to be as lean and smart as possible
3. Optimal utilisation of available resources
4. Lean consists of a set of principles, basic concepts, methods and
techniques that allow employees and managers to achieve significant
results

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The Five Core Principles according to Womack and Jones

Define the
value of a
product or
service from
the customer’s
perspective

Strive for Identify and

perfection visualise the
through value flow and
continuous eliminate
improvement wastage

Switch to a
demand based
Create a
system : “Pull
continuous flow
instead of
Push”

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1. Value definition

1. SAFETY

2. QUALITY

3. DELIVERY

4. COST

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2. Identify and visualise the value flow – Value Stream

A drawing that represents a value stream in a clear and understandable way

What are the flows in our CQV Process:

1. Process
2. Material
3. Personal
4. Information
5. Document
6. Start-up
7. Communication

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2. Identify and visualise the value flow – Value Stream

Value Stream: All activities we undertake to transform input into output

Transport Unnecessary conveyance of goods or information

Inventory Storing / keeping more stock than needed

Motion Making unnecessary movements

Waiting For information, goods or people

Overproduction Produce more than required by the customer

Overprocessing Performing more actions / Taking more steps than necessary

Defects Corrections, scrap, rework, defective products

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3. Create a continuous flow

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4. Pull instead of Push

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4. Pull instead of Push

Having ‘flow’ everywhere is ideal, but:

“where you can’t flow, you must pull”
A pull system works with controlled inventories
Pull avoids overproduction

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5. Strive for perfection through continuous improveme

Implement standard work

Build in quality at the source
Introduce Visual Management

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 THE LEAN FACTOR
Lean thinking and principles can be applied to the C&Q process to drive efficiency. Some lean principles
that are directly applicable to C&Q include:

Define value in the eyes of the customer

> Identify the C&Q activities that add value in terms of product quality assurance.

Understand the process, suppliers, inputs and outputs and the value stream

Identify and eliminate waste. Identify non-value added activities and work to eliminate them.

> First time right – test once, when possible, at the appropriate time and place and document the test properly

> Avoid non-value added reviews and approval signatures

Create Pull

> Define the C&Q deliverables needed from the design and construction process during the front end of the project.
Design activities should highlight critical aspects, specify how, where and when they will be tested and define
acceptance criteria. Specifications should include vendor testing and documentation deliverable requirements.

Continuous improvement

> Capture and share lessons learned and best practices during the project not only at the end. Promote knowledge
sharing

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 Define a clear CQV Strategy

A
Work on CQV fundamentals, how to implement efficiently the QRM approach and the “Plan
Do Check Act” strategy for CQV
Define Global documents associated supporting a clear CQV vision for investment projects
Refine R&R between functions

Lean the CQV Approach

B
Work on complexity reduction such as “nice to have”, unnecessary steps, reuse and recycle
Work on lean CQV project structures in particular the CQV integrated organization and mindset for
investment projects
Implement the “Right Test at the Right Time” mindset

Skills and Tools

C
Work on skills and tools required to efficiently execute CQV phases
Build Metrix to apply the “Plan Do Check Act “ for CQV
Instore trust between function in projects

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