quality thinking in other industries dominic parry · inspired pharma training 05/11/12 pqg...

Quality Thinking

in other

Industries

Dominic Parry Inspired Pharma Training

WEB www.inspiredpharma.com

GMP BLOG inspiredpharmablog.com

Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 2

Welcome

• The traditional focus on quality

• “Quality” in the eyes of GMP

• What does “Quality” mean today?

• “Quality” in other industries

• The evolution of GMP


The aim of GMP

• The aim of GMP is to get safe and effective

product of the right quality to the patient

• Important to have GMP because of the risks of

getting it wrong

• GMP has a fantastic track record when used

properly


What is GMP?

• Product quality standard

– Single customer – patient

• GMP and the inspection process

– Many positives too!

• Single agreed standard across Europe

• Inspection by one Regulatory Authority

• Similar principles adopted around the world

• In many ways still ahead of other sectors


Pharmaceutical quality thinking

• Whilst GMP has many positives – it is not without

its deficiencies!

• In some areas it stood still for many decades –

allowing many other sectors to catch-up and

overtake when it comes to modern QMS thinking


So what’s wrong with GMP?

• Let’s not forget – GMP has many positives!

– But it is not a Quality Management System (QMS)

– It is PART of your QMS, but not a QMS in its own right

– “Quality Assurance therefore incorporates Good

Manufacturing Practice plus other factors outside the

scope of this Guide” EU GMP Chapter 1

– Can encourage the status-quo

– Has little incentive to change and improve


GMP and “Quality”

• Early editions of GMP in the 1970s had a Quality

Control focus and a QC Department

– The 1970s and early 1980s was the QC era for all leading

industries

• QC is still defined in GMP as:

– Sample

– Test / Check / Inspect

– Pass or reject EU GMP Chapter 1


1980s and early 1990s

• The Qualified Person (QP) arrived in GMP

– QPs duties simply added to existing GMP

• The notion of Quality Assurance arrived

– It became a requirement of GMP to have a QA system

– No clear guidance on what the “system” should include

– No additional requirements added for the QA Department

or QA Manager

– Still no mention of QA Department or Manager in the 9

Chapters or Annexes of EU GMP

– At this time other leading sectors where introducing the

notion of QA, whilst GMP gave no formal requirement on

really what QA was


QA within GMP

• Whilst there is still no formal requirement for a QA

Department, there are many QA elements within

GMP

– Training

– Documentation and records

– Supplier approval

– Validation

– Planned preventative maintenance

– Internal audit / self-inspection

– Control of deviations, complaints and recalls


The Chapters of EU GMP

1. Quality Management

2. Personnel

3. Premises & Equipment

4. Documentation

5. Production

6. Quality Control

7. Contracting out

8. Complaints & Recall

9. Self Inspection

Plus Annexes


The pharmaceutical company

Site Head

Planning R&D IT Purchasing HR Engineers Finance QC Prod Sales



Site Head


DIRECTLY

covered

by

GMP


The Chapters of EU GMP

1. Quality Management

2. Personnel

3. Premises & Equipment

4. Documentation

5. Production

6. Quality Control

7. Contracting out

8. Complaints & Recall

9. Self Inspection

Core activities Support activities



Site Head


LIMITED

coverage

by

GMP



Site Head

Planning R&D IT Purchasing HR Finance QC Prod Sales

NO

coverage

by

GMP

Engineers



Site Head




Site Head


All of these departments can impact on

Product Quality and Level of Service

Organisation’s today needs a QMS that is

aligned with the needs of all parts of the business


Quality in the early 1990s

• In 1994 a new Quality Management Standard

arrived:

– ISO 9000 : 1994

– Generic standard for Quality Management

• Was looked at by pharma and was generally

disregarded

– Could be of value for suppliers

– Lacked the depth of product quality focus that already

existed within GMP

– Did focus on the whole of the organisation, rather than

part of the organisation


Late 1990s

• ISO 9000 was in real trouble

– People didn’t like its focus on simply having a procedure

for everything

– Industry didn’t think it reflected their current needs

• No real mention of:

– Processes

– Avoidance rather than checking

– Prevention rather than rejection

– The role of Top Management

– Considering the needs of all customers

– Continual improvement

– Being effective and efficient


Why was this important?

• Other industries were under increasing pressure to:

– Reduce waste and duplication

– Be more competitive

– Think beyond “just” product quality

• Reduce lead-times

• Deliver on time and in full

– Consider the needs of all stakeholders

– Be more ethical and consider environmental impacts

– Be able to react to changing circumstances

– Provide a product/ service that the consumer actually

wanted


Pharma?

• In may ways buffered from economic pressures

– It was only in the 1990s that large sites started to close

– Continued into 2000 and beyond

• With mergers of organisations AND the growth of

the emerging markets COMPETITION has arrived in

Pharma

– One site is compared to another in many ways

• Hence the need for sites to evolve

• Hence the need for our system to evolve


Our system (GMP)

• Traditionally we have focused on Product Quality

– GMP does this. Its focus is Production and QC

• But there are other importance factors to consider in

addition:

– Batches made on time and in full

– Are available where and when needed

– The needs of all customers (internal and external)

– Increased efficiency

– Continual improvement in all areas

• We ignore these factors at our peril if we are to be

competitive as an industry, organisation or site


2000 and beyond

• ISO 9000 evolved

– Much bigger role for Top Management

– QMS linked with business needs and goals

– QMS covering the whole business

– Focus on Continual Improvement and Customer Focus

– Focus on all processes within an organisation together

with their interaction


Processes – typical example

Sales and marketing

Planning

QC

Purchasing

Warehouse

Production

Despatch

Warehouse

QC

Finance

Premises and equipment

Training

Documentation

Engineering

QA

Communication

Validation

Engineering

Corrective action

Preventive action

Continual improvement Internal audit

Management review

SUPPORT PROCESSES SUPPORT PROCESSES CORE PROCESSES


Other industries - processes

• Processes

– Mapped all processes that can impact on product quality

and level of service

– Identified the supplier and customer of each process

– Established what the customer wanted

– Considered what the process needed to achieve

– Set objectives and key performance indicators for

these

– Not just production’s processes – but all processes in the

whole organisation

– Needs to be seen as part of the QMS


Processes

• Process performance is monitored and measured

– Displayed visually

• Notice boards / Visual Boards

• Data on processes analysed

– Opportunities for improvement highlighted, reviewed and

actioned

– Many data gathering techniques are available

• Processes reviewed to identify areas of risk

– Many risk management tools are available


Other industries - avoidance

• Avoidance rather than checking

– Having greater confidence in what is delivered to you in

the first place

– Remember – we have a heavy “QC mentality”

– QC in our world is flawed, as it relies on destructive

sampling

– Other industries have partner with suppliers (procurement

excellence) whereby materials are delivered and used

with no QC tests performed by the purchaser

• Unlikely to every be normal practice in pharma


Other industries - prevention

• Prevention rather than rejection

– Having mechanisms to deliver pro-active risk

assessments

– Programmes in place to perform risk assessments on all

lines, equipment, items and processes

• Focus is not just on risk to the patient. Considers:

– Risk to product quality

– Risk to operators

– Risk to the environment

– Risk to the business

– Looking for areas of waste, duplication and over-working


Other industries – Top Management

• The role of Top Management

– No longer is the QA system owned by the QA Manager

– The QA system is part of the business

– The QA system is the business

• Top Management – it’s YOUR system

– They have the money, the influence, the resources and

the responsibility to influence, change and improve

– Top Management need to demonstrate a clear vision and

strategy for the QMS and commitment necessary

resources to achieve its objectives


Other industries - Management Review

• Top Managers will regularly review their system

– Many times a year during Management Review

INPUTS

• Results of audits

• Customer feedback

• Process performance and product conformity

• Status of preventive and corrective actions

• Follow-up actions from previous reviews

• Changes

• Recommendations for improvement

OUTPUTS

• Improvement of the

effectiveness QMS and its

processes

• Improvement of product related

to customer requirements

• Resource needs – Designed to be a proactive fora

rather than a reactive one


Management review

• Plus – Top Management will visit all parts of the

organisation on some form of schedule

– Perhaps once a week or once a month

– Actively participating in departmental reviews around the

organisation


Other industries - Customers

• Other industries have recognised that there are a

range of customers with varying needs

– Most do want product of the right quality!

• NB – the only customer of GMP is the patient

• External customer

– Wants orders to be considered and evaluated before

acceptance

– Wants to be told if there is a problem

– Wants to be told if an order will be late

– May be worth asking for feedback before complaints

– Wants to see improvements

• Or may take business elsewhere!


• Other industries have recognised that we need to

think about the internal customer

– Organisations are full of internal customers

• NB – not mentioned in GMP

• Internal customer and the individual

– Wants good two-way communication to take place

– Wants their ideas listen to

– Need objectives and appraisals

– Wants to be told if something will not arrived as agreed

– Doesn’t want to send things back because there is

something wrong

– Doesn’t want to chase for things that haven’t arrive

Other industries - Customers


Other industries - Continual improvement

• Everyone says that they continually improve – but

when and how?

• GMP does provide a great focus on dealing with

problems to they don’t happen again

– GOOD – but reactive

– NOT SO GOOD – do we actually get to the root-cause of

the problem all of the time?

– Not helped by having a one-size-fits-all approach to

closing problems by a set day (say 30 days)


REAL Continual improvement

• Mechanisms that promote and drive continual

improvements need to be in place

– Will always need to deal with problems

– Need systems for:

• Encouraging and rewarding improvement ideas

– Teams that will be tasked with making improvements

• Training – 5S, Lean Sigma, Quality Circles, 7 wastes

• Need to be provided with objectives and measured against them

• Need to be actually making process improvements


Continual improvement of all processes


Other industries - Effective & efficient

• Most firms now have departmental boards

– Contains quality metrics on performance of key processes

– Daily meetings with key players occur

– Review recent events, successes, failures and plan for

next few days, weeks and months ahead

• Normal practice in leading industries and is a great

fora for dealing with corrections and corrective

actions as well as looking at process performance


So what for GMP?

• Aren’t we doing this already?

– Many of these ideas are in-place in organisations

– Many have been tried and not continued

– Organisations are now looking at these again and seeing

how they can be used to add value

– Need to be done as part of the QMS not as separate to

the QMS

• ICH Q10 and other quality documents have recently

tried to take elements of ISO and put in a GMP

context

– Looking at factors outside the scope of this guide

– ICH Q10 is not an easy to understand document


So what does this mean for “QA” today?

• Three strategies for change:

• ONE:

– Move from culture of checking and reaction to

prevention and continual improvement

– Easier said than done but:

• Ensure corrective action really is corrective action

• Gather data to ensure problems have been dealt with to the root

cause

• Look at data and suggest ideas for improvement

• Look at processes and design out areas of potential risk


So what does this mean for “QA” today?

• TWO

– Use your internal audit mechanism to look at all

processes of the business and not just the GMP areas

– Focus on compliance as well as identifying opportunities

for process and performance improvement

• THREE

– Don’t use Management Review as a regulatory necessity

– Use it as a driver of the QMS and the business

– Use it to regularly review process performance and take

action accordingly

– Use it to integrate quality initiatives


Why is this important?

• The evolution of QMS thinking started to occurred in other

sectors nearly 2 decade ago

• Regulatory pressure is encouraging a more holistic view of

quality

• Sites are under increasing pressure to be inspection ready

AND be more efficient

• There are many sites that have closed – often not because

of poor GMP practices

• It is in all of our interest for sites to stay open and make

quality medicines

– Better for jobs, the economy and is arguably a safer and shorter

supply chain

• We need to embrace these ideas from other sectors


Keep in touch with us ….

[email protected]

www.inspiredpharma.com

Blog: inspiredpharmablog.com

Twitter: @Inspiredpharma

LinkedIn: Dominic Parry

Facebook: Inspiredpharma

GMP, Pharmaceutical Lead Auditor, Quality

Management and Qualified Person (QP) training

Thank you for listening

quality thinking in other industries dominic parry · inspired pharma training 05/11/12 pqg...

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