Pharmaceuticals

Qual i t y Management

by
Ravi n Paw ar

Pr oduc t Management Gr oup, 3i I nf ot ec h Lt d.

Or i on t ow ar ds Robust Qual i t y Syst em
Qual i t y i s our Passi on


This white paper covers quality management in the process manufacturing industry. The main focus of
this paper is on how to improve quality of the manufacturing process, total quality management and
quality inspection. Finally, a brief description of how quality is handled through the ORION product suite is
given.









T TQ QM MT TE EC CH HN NI IQ QU UE E
Globalization and increasing competition have brought a sense of urgency in
inducting highly successful total quality management techniques.
By employing quality principles in controlling process waste, it was realized that
quality could no longer be restricted to a designated quality department; it
needed to spread across the company. This led to the concept of Total Quality
Management or TQM. TQM marks the beginning of a new era, in which
managers focus on customer values, cross-functional systems and continuous
improvement.

This paper presents the basic ideas and components of quality management in
ORION.
A AB BS ST TR RA AC CT T


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Quality is never an
accident. It is always the
result of high intentions,
sincere efforts, intelligent
direction and skillful
execution.

















Quality awareness
must begin at
conception of the
product and continue
through various stages of
development and
manufacture.











Quality is never an accident. It is always the result of high intentions, sincere
efforts, intelligent direction and skillful execution. It is an attribute or a
characteristic factor whose dictionary meaning is the degree of goodness or
worth of a person, place or thing. In determining the quality of a product, the
customer's expectations about the product are given top priority. In the present
scenario, customer delight is the need of the hour to survive the cutthroat
competition.
There are different approaches through which the concept of quality can be
understood. According to the product based approach, quality is an attribute
that can be measured quantitatively. The manufacturing based approach, on
the other hand, uses the universal definition of conformance to requirements.
The value based approach says that the consumer purchase decision is based
on consistent quality at an affordable price.
T TQ QM M C CO ON NC CE EP PT T
In the current market environment, the quality of the products has become a
major concern for manufacturing industries. To be competitive, any industry
needs to provide a product/service, into which quality is designed, built,
marketed and maintained at the most economical cost that brings customer
delight instead of mere customer satisfaction. This need for bringing in the
competitive edge drives process manufacturing industries to adopt the Total
Quality Management approach.
The job of quality management is not just advising a sampling plan for the
acceptance/ rejection of incoming materials or products, and controlling the
manufacturing process conditions. It is, in fact, a job at every stage of the
company's activities.
Quality Management is a company-wide activity, involving the combined efforts
of various departments such as R&D, engineering, logistics, production and
human resources, in different phases with a view to achieve the desired quality
of end product.
Quality awareness must begin at conception of the product and continue
through various stages of development and manufacture. Feedback from the
users during its use is essential for continuous product improvement.
T TQ QM MV VI IS SI IO ON N
The quality cycle begins and ends with the user. It starts when the user's need
is analyzed to design a product. During the development and manufacture of
the product, various departments and sections of the company contribute in
building quality into it. The cycle ends with the user, because the final proof of
product quality is during its use by the user. The delight of the user is the
ultimate aim of this concept. Quality is no longer the exclusive domain of the
inspectors, manufacturers and the government agencies. Even sales personnel
have their role to play in the achievement of the primary objective of quality.
Quality Management has, as does any management process, three main
components:
Quality Planning - Designing the desired & deliverable
quality standards.
Quality Implementation.
Quality Monitoring and control.


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Quality is no longer
the exclusive domain of
the inspectors,
manufacturers and the
government agencies. To
improve a process, it is
important to look at the
socio-cultural issues of
the organization
















The benchmarking
approach not only
provides a comparative
profile, but also helps the
management to identify
innovative products and
services.






It is imperative that TQM efforts are properly organized to co-ordinate the
various contributing aspects of quality. Organizations are made up of a complex
system of customers and suppliers. People pay attention to who supplies them;
with what they need to do their job and who the customer is for their product.
Quality is certain when everyone becomes concerned about meeting their
customers' requirements.
In meeting the customers expectations, the focus must be on the process and
not just on the results. To improve a process, it is important to look at the socio-
cultural issues of the organization. This is to create a healthy and open
atmosphere, in which people are willing to open themselves up for introspection
on their processes. This is something the management must be able to
facilitate.
In contrast to the traditionally managed organization, TQ managed
organizations believe that there is always scope for improvement, despite the
absence of complaints from the customers, Everyone in the organization is
trained to plan & participate in group meetings, brainstorming sessions and
become primary vehicles for planning and creative problem solving. Each
member in the team is recognized & rewarded. Errors and problems are viewed
as opportunities for learning, rather than blunders to be punished.
In the recent past, TQM received formal recognition by way of ISO 9000. In
order that organizations may successfully compete with world-class leaders, it is
imperative to be prepared for quality even beyond the popular ISO 9000.

T TQ QM MT TE EC CH HN NI IQ QU UE ES S
B Be en nc ch hm ma ar rk ki in ng g
For many companies benchmarking has become a significant component of
their TQM Program.
In most developing countries, until recently, a majority of the industries had a
few products and services, which differed markedly in their utilitarian
characteristics. However, such a situation is hardly sustainable with increasing
competition from foreign goods and services. In such a situation, competing
firms have to improve continually. The benchmarking approach not only
provides a comparative profile, but also helps the management to identify
innovative products and services. Benchmarking is a continuous process of
measuring one's products, services & practices against the toughest
competitors. With the growing emphasis on quality, it is of great significance in
the present competitive world. It involves identifying the best practices in the
industry and adopting the suitable ones to ensure superior quality goods, and
consequently, increased profitability.
B Bu us si in ne es ss s P Pr ro oc ce es ss s R Re ee en ng gi in ne ee er ri in ng g
Business Process Reengineering generally redesigns the processes of an
organization. It is used to reduce the number of boundaries crossed by the
manufacturing process. Each time a process crosses an organizational
boundary, opportunities for errors arise. Business Process Reengineering is the
rethinking on fundamental issues. Radical redesign of business processes is to
achieve dramatic improvements in performance, such as cost, quality, service
and speed.



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To retain their
competitive edge,
companies need to
change their traditional
ways of working, to learn
more about their
customers.























For example, in a process manufacturing industry, this can be achieved
through process validation, analytical method validation and equipment
qualification. Validation standardizes the process, testing method and
equipment performance. Specifications can be created from this.
P Pr re ec ca au ut ti io on ns s
Wherever the responsibility of quality management is to be delegated to
different departments, it needs to be done with many precautionary measures,
thereby ensuring that monitoring and control is in the hands of quality
management people. The hierarchy structure of quality management should be
kept as small as possible, and the span of control, as broad as possible. As the
traditional organizations are unable to meet the present challenges, there is
every need for new techniques and philosophies with which organizations can
survive and thrive under grueling competition. To retain their competitive edge,
companies need to change their traditional ways of working, to learn more
about their customers. No organization can afford to overlook the customer,
competition and then the changing needs; the three vital forces of today's
competitive environment. TQM is an important milestone in the ongoing
evolution of the management field.
When it comes to the level of quality that is acceptable in todays manufacturing
marketplace, one fact stands out. State-of-the-art customers are not willing to
accept less than state-of-the-art products from their suppliers. The requirements
of these customers can be met only through advanced manufacturing
operations. This is achieved by making 100% perfect parts and products at
constantly reduced cost and increased productivity.
Quality control should ideally offer automation in process calculations, and
generate the certificate of analysis for the necessary approvals. Option for
selection of sampling plan, sampling size and assurance issues are also
required.
The principles of quality control are considered under the following heads:
Raw material control
Process control
Finished product inspection
ORION supports all three principles of quality control through inspection.



















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Figure 1 Flow for Raw material and packaging material inspection:





















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Figure 2 Flow for finished goods inspection


Figure 3 In-process Online inspection







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The following activities with respect to quality are necessary for any
manufacturing set up:
Releasing or rejecting of raw materials
Establishing a system to release or reject raw materials,
intermediates, packaging and labeling materials
Making sure that critical deviations are investigated and
resolved
Approving all the specifications and master production
instructions
Approving all the procedures potentially impacting the
quality of intermediates and finished goods
S ST TA AB BI IL LI IT TY Y S ST TU UD DY Y
The purpose of stability testing is to provide evidence on how the quality of a
drug substance or the drug product varies with time under the influence of a
variety of environmental factors such as temperature, humidity and light. It
enables recommended storage conditions; re-test periods and shelf lives to be
established.
Certificate of analysis and Out of specification report can be generated in
ORION.
CAPA (Corrective action and preventive action): CAPA is a well-known concept
that focuses on investigating and correcting discrepancies and attempting to
prevent recurrence. Quality system models discuss CAPA as three concepts, all
of which are used in this guidance.
Remedial corrections
Root cause analysis with corrective action to prevent
recurrence
Preventive action to stop the initial occurrence
Q QU UA AL LI IT TY Y I IS S A AL LS SO O C CO OS ST T R RE ED DU UC CI IN NG G F FA AC CT TO OR R
The first step to reducing the Cost of Quality for new products is designing for
quality and reliability. Quality inspection is the best way to reduce the cost of
finished goods items. Some examples are given below:
C Co os st t o of f q qu ua al li it ty y f fa ai il lu ur re e
Rework
Diagnostics (the cost of discovering what is wrong)
Re-inspection of rework
Scrap, that is the value up to that point of whatever cannot
be reworked
Value of replacement materials and parts
Purchasing actions to procure replacement materials/parts
Analysis of quality problems
Cost of planning and corrective actions


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Supplier corrective actions and change-induced quality
costs
Setup change scrap/rework until first good part
Sorting/screening out sub-optimal merchandise
Inventory carrying costs for extra inventory caused by
quality problems
Discounting sub-optimal merchandise
Change orders to the correction of design
Change-induced quality costs
F Fa ai il lu ur re e i in n t th he e F Fi ie el ld d
Dealing with customer complaints
Refund/compensation/allowance costs
Returned goods
Warranty costs
Recall, retrofit and patch costs
Penalties
Liability costs
Goodwill, reputation degradation
Damage control costs
Lost sales
M Mi it ti ig ga at ti io on n
Quality can not be compromised in the competitive market.
I In ns sp pe ec ct ti io on n/ /T Te es st ti in ng g
Incoming inspection
In-process testing
Diagnostic tests, including the cost of testers and test
procedure development
Final testing
Internal quality audits
Field quality audits
Corrective actions on all of the above
Equipment test and calibration
P Pr re ev ve en nt ti io on n
Quality planning and programs
Training
Designing in quality and reliability
Process controls


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Quality audits
Qualifying suppliers
Preventive maintenance

Figure 4 The Complete Quality Management System


Understanding the customers expectations and translating
them into quantifiable measurements.
Using data to understand if the current process
performance is capable of meeting the customers
expectations. First, the customers are identified and their
expectations defined. Then it is ascertained if the current
process is capable of meeting these expectations.
Validating the root causes that hinder a process from
performing as expected. After those root causes have been
identified, either current process data or the historical data
is collected and analyzed to determine the true (root)
causes.
Implementing solutions and establishing the control
measurements. Customers do not experience the average,
they only feel the variation. Therefore, after validating
actual root causes, solutions need to be identified and
implemented that reduces or eliminates the process
variation.





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Figure 4 The Process of Quality Management System



G GL LO OS SS SA AR RY Y F FO OR R Q QU UA AL LI IT TY Y
Accuracy/Precision Accuracy refers to how closely the
data value agrees with the correct or true value. Precision
is the ability of a measurement or analytical results to be
consistently reproduced, or the number of significant digits
to which a value has been measured or calculated.
Completeness Completeness measures the presence or
absence of data.
Reliability Reliability is the relative measure of how much
confidence one can place in the data values.
Availability Availability is the ratio of the amount of time
data is available to the amount of time data is needed for
access.
Timeliness/Freshness Data almost always has an
associated timing or freshness attribute or component
for it to be relevant.
Consistency Consistency is the common definition,
understanding, interpretation and calculation of a data
element.
Uniqueness Data must have a unique identity and
definition to calculate the lifetime value of large customers.






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C CO ON NC CL LU US SI IO ON N

ORION provides solutions for quality testing of incoming and outgoing material,
as well as quality certification to the utmost satisfaction of the customer. It offers
automation in process calculations and generates the certificate of analysis for
necessary approvals. ORION has the option for selection of sampling size and
sampling plan. It enables the user to define QC criteria with stage-wise
requirements, sampling plans and accepted quality levels. Validation is
available against defined inspection criteria, as also lot-wise test results. Stage-
wise QC during production process enables reporting on quality with trend
analysis. The aim to provide a total quality solution.