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In many industries, particularly the pharmaceuticals sector,

the strict regulatory requirements and the challenges of


staying competitive in a fast-changing environment are not
only increasing the pressure on sales, production and ad-
ministrative functions, but also on quality assurance depart-
ments. The QA team is now expected to keep control of
quality, costs, reliability and speed, while also complying
with regulations.

If this is to be achieved, quality assurance must become
a proactive process which ensures that product manu-
facture adheres to specific standards and strives to con-
tinuously improve results and eliminate errors. In a nutshell,
products should be fit for purpose and right first time.
By optimizing process reliability and efficiency, quality as-
surance can bring about speedy and effective operational
performance which still observes all statutory requirements.
To ensure the sustainability of this success over the med-
ium to long term, quality assurance also needs to lead quality
enhancement initiatives, eliminate activities which do not
add value, reduce the cycle time required to handle and re-
solve quality issues, and lessen reoccurrence of deviations.
Achieving this is no mean easy and it is crucial that the
right control system is clearly defined and closely enforced
for meeting the required standards and attaining quality
improvements along the way. In reality, many companies are
experiencing troubles with this challenge, finding that
support functions, such as quality assurance, are increasingly
tied up with administrative activities, reducing the time
they can spend on the shop floor preventing issues and
directly adding value to the end customer.
However, any trend such as this also provides us with
many opportunities for optimizing and better organizing QA
activities. We urge pharmaceutical companies to acknow-
ledge the need to streamline their operations, improve flow
and operational speed, while minimizing unnecessary
tasks in which time and money is wasted. Now is the time
for them to structure their organizations around the key
processes that add value to patients and users.
This article presents Tefens holistic approach as a method
of QA process optimization, aiming to help organizations
pursue business growth by becoming more proactive when
dealing with failures and/or risks, reducing fire fighting situ-
ations and attaining higher levels of customer satisfaction.
Moreover, with the use of lean methodologies and techniques,
Tefen can help companies to significantly increase resour-
ce efficiency and successfully manage high and fluctuating
workloads.
Implementing process optimization
The holistic approach from Tefen starts with a diagnostic
benchmarking stage, which assesses three key factors:
a sites strategic priorities, performance and practices. This
then allows us to formulate customized recommendations
for the specific objectives and constraints of each company,
Copyright 2012 Tefen Management Consulting. All rights reserved.
Optimizing Processes and Organization
Quality
Assurance
in the
Pharmaceuticals
Industry
By Pete Caldwell, Alex Sifniotis and Edite Laka
Copyright 2012 Tefen Management Consulting. All rights reserved.
giving valuable insight into what other organizations with
the same issues have done to improve their areas of low
performance.
1. Strategic priorities
Before any structural changes are made, it is crucial to
specify the priorities of each site. Conducting specially
designed interviews gives us an understanding of the
drivers, constraints and overall philosophy, with its principles
and trade-offs. This then enables us to define high-level
targets for cost, quality and delivery metrics. Once site
priorities have been set, a process/function matrix is used
to prioritize the key business processes within the scope.
Processes are prioritized according to their impact on
quality and drivers, such as workload per department,
cost, lead-time, customer value etc.
2. Current state: Performance and practices
An analysis of current practices at the site and their im-
pact on performance forms the foundation for any change
and is crucial to the success of the program. Workshops
are used to identify the process steps, inputs and outputs,
and to clarify accountabilities. These processes are map-
ped, focusing on the most critical 10-20 QA processes.
Customers, outputs, suppliers and inputs are specified for
each of the processes and subsequently, each of the
process steps is categorized as either value adding, non-
value adding or required for sustainable business. In
addition to process mapping, working practices should
be observed and analyzed. The aim of all this is to establish
the impact of practices on quality and to quantify the per-
formance in terms of lead-time, FTEs or other costs, before
benchmarking performance levels with other sites in the
industry. At this stage it is essential to invest time on site to
develop root causes and agree action plans with the teams.
3. Future state
For an organization to be successful it should have a
clear vision and processes designed to maximize value to
the customer. At this stage, each of the mapped proces-
ses is analyzed, in close cooperation with the teams per-
forming these activities, to determine the optimum measures
for process streamlining and removal of any waste and
NVA activities. Benchmarks and best practices are brought
in, assessed and incorporated where suitable to improve
QA activities. Once the processes have been streamlined,
the structure can be designed to enhance their output.
Roles, responsibilities, accountability and interfaces are re-
designed whilst taking into account existing knowledge
and skill levels. Roles and structures may also be bench-
marked, to provide a view of how other similar companies
are organised (see summary of Tefens 2012 QA organi-
sation benchmark, below). A training plan is designed to
enable speedy and effective transition. When the projec-
ted benefits of the improved processes have been quantified,
new performance targets are set and KPIs introduced
to monitor and promote the effectiveness and reliability
of each process.
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QA process benchmark: functions involved (in Management, and Execution, for each process)
Figure 01: Benchmark of life sciences QA organisations, highlighting the functions involved in each QA process (management on the left, execution on the right)
Copyright 2012 Tefen Management Consulting. All rights reserved.
4. Roadmap
The roadmap should translate all these recommendations
into a tangible and explicit work plan to enable a com-
plete, timely and successful implementation. This includes
detailed work streams, responsibilities, timescales, and re-
source requirements. The roadmap should clearly illustrate
the exact route to be followed by the organization, in order
to achieve the desired future state, while also assessing
the benefits of each work stream and prioritizing them
accordingly. It is imperative that the quality leadership and
management teams agree and sign off on the roadmap to
guarantee a successful implementation phase.
Case study
Introduction
A global pharmaceutical company had experienced
increased deviations and claims over the past year, which
alerted them to deterioration in product quality. Overload-
ed with administrative tasks, the support functions had a
low presence on the shop floor and were unable to pre-
vent quality issues. The company needed to focus more
on pursuing quality enhancement and strive to anticipate
issues in advance instead of just reacting to unexpected
events. In addition to the long term objective of corporate
growth within the network through major cost reductions,
the company had an initial target to reduce overall QA
administrative workload and decrease the workforce from
30 to 25 FTEs by optimizing 14 QA processes.
Tefen was asked to apply the above problem-solving meth-
odology and design a lean QA operation in order to improve
quality performance and reduce administrative costs.
Strategic Priorities
The priority ranking approach revealed that the key site
drivers were quality (non-negotiable and a top priority for
the site, especially bearing in mind recent quality issues)
and cost (playing a key role in bringing new products
to the site and satisfying clients). Meanwhile, the major
constraint was perceived to be infrastructural manage-
ment (the overwhelming QA workload and the organiza-
tional structure - sub-optimal knowledge, skills, roles and
responsibilities of personnel).
In light of the above, the strategic project objectives
were agreed to be:
Enabling anticipation of issues instead of fire-fighting
(quality)
Decreasing admin. activities to allow time for walkthroughs
on the shop floor to identify issues, confirm SOP etc.
and hence increase quality performance (quality)
Reducing overall QA workload and workforce from
30 to 25 FTEs (cost)
Current State: Performance
Focusing on the priority areas, key performance data was
collected from the site and assessed against relevant QA
departments at similar pharmaceutical sites, using Tefens
benchmarks, to identify areas for improvement.
CURRENT
2
PERFORMANCE
Costs
Delivery
Flexibility
Lead-time
Inventory
Quality
Productivity
Headcount
Layers, spans
PRACTICES
Strategic approach
Technology, systems
Facilities, layout
Org structure
Planning, scheduling
QA & QC processes
KPIs, mgt & routines
Culture, leadership

Root cause
analytics
VISION
3
PERFORMANCE
Costs
Delivery
Flexibility
Lead-time
Inventory
Quality
Productivity
Headcount
Layers, spans
PRACTICES
Strategic approach
Technology, systems
Facilities, layout
Org structure
Planning, scheduling
QA & QC processes
KPIs, mgt & routines
Culture, leadership

Impact
analysis
STRATEGIC PRIORITIES ROADMAP
COMPETETIVE
Price
Quality
Service
Uniqueness
Ethics
COST
Action plan, with
invenstment and
resources required
to achieve vision state
1 4
CONSTRAINTS
Facilities
People
Supply
Demand
Cash
BENEFIT
Gap between
current and
achievable
performance

TRADE-OFFS
Long-term vs short-term
Utilisation vs flexibility
Cost vs risk
Business
case
Tefen
Bench-
marks
Tefen
Bench-
marks
Copyright 2012 Tefen Management Consulting. All rights reserved.
Current State: Practices
The next step in the site analysis was a review of current
QA support practices. Detailed process mapping sessions
were used to identify areas of low performance and high
cost, establishing major root causes and classifying each
action as either value adding, non-value adding or sustain-
ing activity.
ARCHIVING
C
P

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p
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A


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A

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Release lot /
send document
Deliver
Documents to
Bldg 3
Remove plastic,
re-order pages
and staple (10 min)
Move case to
warehouse
Deliver
case
Print 2 copies for
all required COAs,
sign, scan & email
to QP (30 min)
Yes
No
Check COAs, prints,
signs, scans & email to
archive
Country
specific
COA?
Generate general COA
Provide case
number
COAs
already exist
in team site
Exel
format does
not match
archive`s
Print approved
Docs & staple to
lot record, scan to
Team site (15 min)
10-20 Min.
wait for each
COA
File Docs in folder
& write lot No.
outside (5 min)
Place all folders
from one bulk lot
in one box
File Docs in folder
& write lot No.
outside (5 min)
Store 5
boxes in
case & label it
(20 min)
Send Exel file
to Record
Manager (5 min)
When space fills
(~3y). order case
and case number
Assign case to
pallet & update
pallet list
DETAILED
PROCESS
MAPPING
IDENTIFICATION
OF
ISSUES
ARCHIVING
C
P

o
r

o
t
h
e
r


S
u
p
p
l
i
e
r
C
o
u
r
i
e
r
Q
A


A
r
c
h
i
v
e
Q
A

R
e
c
o
r
d

M
a
n
a
g
e
r
Deliver
Documents to
Building 2
Remove plastic,
re-orient pages
Bldg 1 only (5 min)
File Docs in folder
(~15) & write lot #
outside (5 min)
Update reference
Exel of Bulk & lot
numbers (5 min)
Store 5 boxes in
case & label it
(20 min)
Deliver case Move
case to
warehouse
Provide case number
When space fills
(~3y), order case
and case number
Send Exel file to
Record Manager
(5 min)
Assign case
to pallet
& update
pallet list
Yes
3,177 lots
(2011)
No
2,385 lots
(2011)
Product 1
Bldg 1 COA
created by Archive
(instead of the
building`s QA)
Manual Doc
searching since
other sites don`t
use team site
Physical
handling and
storage of
paperwork
Docs
arrive un-
organized
1
2
3
5
Send document
6.839 Docs / year
(2011)
General
COA
for Bldg 1
Yes = 792 lots (2011)
Search for COA
(7 min instead of 2)
Generate general
COA (5 min)
Documents for 1 Bulk lot
include 1 Preparation lot, 1
Production lot, 1 Fill lot, 1 CIP/
SIP + 10-20 packaging lots
RECOMMENDATIONS
1. Bldg 1- Ensure documents arrive organized and plastic-free to the archive 5 min each*3,177 docs (2011)
2. COA generation to be done as part of lot review to avoid delays in release as done for bldg 2
3. Work with other site to use the team site appropriately
4. Work with IT to speed up COA generation
5. Long-term: electronic batch records to eliminate handling of physical papers
4
10-20 Min
wait for
each COA
Place all folders
from one bulk lot
in one box
CATEGORISATION
OF
VA AND NVA STEPS
ACTION
ORIENTED
RECOMMENDATIONS
Current State
Current State with opportunities for improvement
Copyright 2012 Tefen Management Consulting. All rights reserved.
Future State
Tefen designed the future state in collaboration with the cli-
ent. All this stage, waste was eliminated from all steps within
each of the 14 QA processes that were chosen for analysis
and new streamlined processes specified that would enable
a more timely and efficient result for the internal / external
process customers. The benefits from each of the quality
improvements were quantified in terms of lead-time, FTEs or
other costs so that individual initiatives could be prioritized
accordingly.
Roadmap
An action plan was compiled with all recommendations
and process owners were assigned to be responsible
for the successful implementation. The roadmap was
comprehensive, including tasks for all 14 processes, and
distinguishing between quick wins, short, medium and
long term benefits.
Results
Direct process efficiencies
Potential for improvement through the reduction of waste
and elimination of non-value adding activities was found
in each and every one of the 14 process analyzed. The
total workload reduced by these improvements can be
translated into 4.32 FTEs savings which can be deployed
elsewhere.
Task-level efficiencies (reorganization of
process/people distribution)
Having mapped each of the 14 QA processes, a compari-
son was done between the workload shown from these
maps and the actual time being spent on these activities
in the current situation. This comparison revealed a sig-
nificant discrepancy between the two workloads, espe-
cially regarding processes that were performed on a full
or part time basis by a large number of individuals. In the
most extreme situations, processes were spread across
13-14 QA associates, despite the workload requiring no
more than 2-3 FTEs (according to process maps), lead-
ing to significant losses of efficiency, and time and effort
being wasted communicating and coordinating amongst
this large group of participants. By reassigning roles and
responsibilities and achieving a more balanced spread of
the workload amongst associates, an extra saving of 2.3
FTEs was achieved.
Error reduction benefits (quality improvement)
The high administrative workload of QA, together with its
misplaced focus and removal from the shop floor was to
a large extent responsible for the deterioration of product
quality. Further to the efficiencies attained above, pro-
cesses were redesigned to bring QA closer to the shop
floor and prevent future quality issues from occurring.
Some of the FTE savings above were reinvested in new
processes, including the introduction of Gemba walks in
order to optimize the quality system, ensure SOP compli-
ance, identify further improvement potential, and prevent
quality issues (by using risk assessment tools and moni-
toring). In addition, the knowledge obtained during the
Gemba walks was beneficial in ensuring that the SOPs
reflected the latest internal and external guidelines and
regulations.
Conclusion
A holistic approach of QA process optimization and orga-
nization can generate a quality culture across a pharma-
ceutical organization and help to overcome the challenges
faced. The purpose of process optimization is to focus on
value adding activities so that value and responsiveness
to the customer are maximized and waste and delays are
eliminated. Tefen shows how lean practices should be
applied in an organizations structure and processes to
encourage continuous improvement.
Pete Caldwell, Managing Director, Tefen UK
Alex Sifniotis, Senior Project Manager, Tefen UK
Edite Laka, Consultant, Tefen UK