1. By: Mr. Pankaj Sharma

2. QUALITY MANAGEMENT SYSTEM
(QMS)
 A quality management system (QMS) is a formalized
system that documents processes, procedures, and
responsibilities for achieving quality policies and
objectives.
 A QMS helps to coordinate and direct an organization’s
activities to meet customer and regulatory requirements
and improve its effectiveness and efficiency on a
continuous basis.

3. PURPOSE OF QMS
systems serve many purposes,
Quality management
including:
 Improving processes
 Facilitating and identifying training opportunities
 Engaging staff
 Setting organization-wide direction

4. BENEFITS OF QUALITY MANAGEMENT
SYSTEMS
 Implementing a quality management system affects every aspect of an
organization's performance.
 Two overarching benefits of quality management systems include:
Meeting the customer’s requirements, which helps to install confidence
in the organization, in turn leading to more customers, more sales, and
more repeat business.
Meeting the organization's requirements, which ensures compliance
with regulations and provision of products and services in the most cost-
and resource-efficient manner, creating room for expansion, growth, and
profit.

5. ELEMENTS AND REQUIREMENTS OF A
QUALITY MANAGEMENT SYSTEM
General elements of QMS includes:
The organization’s quality policy and quality objectives
Quality manual
Procedures, instructions, and records
Data management
Internal processes
Customer satisfaction from product quality
Improvement opportunities
Quality analysis
Each element of a quality management system serves a purpose toward the
overall goals of meeting the customers’ and organization’s requirements.
Ensuring each of the elements of a QMS is present ensures proper execution
and function of the QMS.

6. ESTABLISHING AND IMPLEMENTING QMS
Establishing a quality management system helps organizations run
effectively. Before establishing a quality management system, the
organization must identify and manage various connected, multi-
functional processes to ensure customer satisfaction is always the target
achieved.
The basic steps to implementing a quality management system are as
follows:
 Design
 Build
 Deploy
 Control
 Measure
 Review
 Improve

7. DESIGN AND BUILD
 The design and build portions serve to develop the
structure of a QMS, its processes, and plans for
implementation.
 Senior management must oversee this portion to ensure
the needs of the organization and the needs of its
customers are a driving force behind the systems
development.

8. DEPLOY
 Deployment is best served in a granular fashion i.e.
breaking each process down into sub processes, and
educating staff on documentation, education, training
tools, and metrics. Company intranets are increasingly
being used to assist in the deployment of quality
management systems.

9. CONTROL AND MEASURE
 Control and measurement are two areas of establishing a
QMS that are largely accomplished through routine,
systematic audits of the quality management system. The
specifics vary greatly from organization to organization
depending on size, potential risk, and environmental impact.

10. REVIEW AND IMPROVE
 Review and improvement deal with how the results of an
audit are handled.
 The goals are to determine the effectiveness and
efficiency of each process toward its objectives, to
communicate these findings to the employees, and to
develop new best practices and processes based on the
data collected during the audit.

11. What is ISO9001?
• It’s aquality management
system that canbe
adopted by any kind of
organization
• Thesystem is focused
towards the meetingof
customer requirements
and enhancing of
customer satisfaction
Keywords:
1. Quality
2. Management system
3. Customerrequirements
4. Customersatisfaction

12. What is ISO9001?
• Thissystem has5 components or elements and
they are applied within your business
management:
a) Leadership
b) Planning
c) Support and operation
d) Performance evaluation
e) Improvement
• Before we explore these elements, why isISO
9001 necessary for our organization?

13. What isquality….
Customers
provides
Organization
Products / services
requirements
supplies
Characteristics
How was it?
Satisfied? Not satisfied?
improve
1
2
3
4
5
“Degree to which a set of inherentcharacteristics
fulfils requirements”
(source – ISO 9001:2015)

14. “Quality Management System -Requirements”
ISO9001:2015….
International Standard published byISO
Prescribes set of requirements relatedto
aquality management system
Conformity can be assessedinternally as
well asby external parties
World’s first certifiable QMSstandard

15. Quality Policy….
Part of QualityManual
Published on Intranet
ExpressesT
opManagement’s
commitment towards quality
All employees MUSTunderstand and
apply the qualitypolicy

16. Why do we need ISO9001?
• T
obe effective in whatever we do, we need a
system of doing things to be consistent.Justlike
craftsmen, managers need agood management
tool to get the job done.
• There are too many activities in any organization.
Easy to lose track of things and focus. Easy to get
distracted. Managers need a good system to keep
things in order.
• Systemizing of activities is anatural
phenomenon. Wedo it all the time– privately,
publicly or commercially

17. Continue…..
• Abusiness faces great risks – big
investments, customer expectations, jobs,
credibility, etc. Thebusinessowner must
do all he canto ensure success,or he/she
will fail.
• Everymajor economy in the worldadopts
it! Governments give recognition to it.
Becauseit works.

18. Biggestbenefit
• TheISO9001:2015 Standard
provides managerswith a
tool that is designed to
continually improve their
businessperformance.
• ISO9001 requires youto:
– Plan what you want todo,
– Follow that plan,
– Monitor, measure and
analyze your executionof
the plan, and
– Improve the plan.
Planning
is the key
P D C A

19. • Awell-designed and well-implemented quality
management system canand shouldeliminate
• Ineffectiveness
• Inefficiencies
• Problems
• Errors
• Inconsistencies
• Malicious practices
• Uncertainties
• Bad culture

20. ISO 9001History
It all started when the USMilitary were getting sub-par products from their suppliers.
Thenit caughton.
YEAR STANDARDS TITLE
1959 MIL-Q-9858 QUALITYPROGRAMREQUIREMENTS
1969 AQAP NATOALLIEDQUALITYASSURANCEPUBLICATIONS
1974 BS5179 GUIDELINESFORQUALITYASSURANCE
1979 BS5750 SPECIFICATIONFORDESIGNDEVELOPMENT,PRODUCTION,
INSTALLATIONANDSERVICING
1987 ISO9001:1987 Model for quality assurance in design,development,
production, installation, and servicing
ISO9002:1987 Model for quality assurance in production, installation,and
servicing
ISO9003:1987 Model for quality assurance in final inspection andtest
1994 ISO9001:1994 QUALITYSYSTEMS– MODELFORQUALITYASSURANCE
2000 ISO9001:2000 QUALITYMANAGEMENTSYSTEMS-REQUIREMENTS
2008 ISO9001:2008 QUALITYMANAGEMENTSYSTEMS-REQUIREMENTS

21. 8Quality ManagementPrinciples
TheISO9001
Standard is based
on theseprinciples
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. Systemapproach to
management
6. Continual improvement
7. Factual approach to decision
making
8. Mutually beneficialsupplier
relationships

22. System and processapproach
• Quality must be managedby asystem
• Thesystem must be managedusing the
process approach becausethe system ismade
up of processes
• Theseprocessesare linked to eachother
• Aprocess hasinputs , resources, activities,
outputs and customers. Manage them all.

23. Systemapproach
• Quality must be managed by asystem to be
effective
• Thissystem is done for you, asrepresented by
the ISO9001:2015standard
• Recall:Asystem is aset of interrelated or
interacting elements
• Systemapproach is described in Clause4.1
• Combination of all Clause matches the PDCA
approach to process management - Plan, Do,
Check,Act

24. Processapproach
input Yourprocess output
Canbe applied to any
other process that you
manage
Or Service

25. Anatomy ofa
process
Process
Inputs
Activities
Outputs
Resources
Everyprocess
hasan owner

26. Processmanagement

27. YourQMS
Quality
management
system
General
requirements
Documentation
requirements
Leadership
Support and
operation
Performance
evaluation
Improvement

28. Typesof records/documented Informationtomaintain
• Gothrough the ISO9001 standard or your QualityManual
• Identify the following phraseswhere they appear:“Documented
Information …
…shall bemaintained”
• Most of the records requirements are readily available, such as
product planning records, product design records, purchasing
records, production records, monitoring records, analysisrecords,
employee performance appraisal and training records, job
descriptions, organization chart, infra maintenance records,
contract/sales records, marketing records, customer complaints
records, etc.
• Recordspertaining to the mandatory SOP’sand quality objectives
shall be created.

29. What todo
• Readquality policy and quality manual
• Establish aQuality Policy for your ownBusiness.
• Appoint aManagement Representative
• Establish aQMS Committee
• Establish your Quality Manual
• Establish the procedures Establish your QualityPlan
• Establish your Department/Process Control Plans
• Establish and document your quality objectives
• Establish your KPI’sand start collecting data
• Implement all theprocedures

30. KeyPerformanceIndicators
• Askthis question when
determining KPI’s:
• Asthe employee of this
organization, what data will
instantly giveme the ability to
assessoverall performance at any
given point of time?
• Thenlist all themdown and
select your desired KPI’s.
Balanced
scorecard
Financials
Processes
Customers
Human
capital

31. • Canbe used to benchmark
performance basedon input
requirements (customer wants100
units per month, sogive them 100
units per month)
• Canbe used to improve KPI
performance levels – decision must
be basedon past performance data
and existing capacity to berealistic
• Youcan useexisting performance
levels to establish your quality
objectives
Quality
objectives
• Usequality objectives to improveon
productivity levels, decreaseerrors,
improve speed, reduce costs, reduce
complaints etc..

32. Employeeresponsibility
• Know the QualityPolicy
• Aware of the relevance andimportance
of their activities and how they
contribute to the achievement of the
quality objectives
• Comply with the requirements of the
QMS,asstated in the Quality Manual,
procedures, Quality Plan,etc.
• Provide feedbacks or ideas aboutthe
QMS
• Report anynonconformities

33. Typesofresources
• Determine , provide and manage the following:
a) Competent human resources (competency
assessment, training needs analysis)
b) Suitable and well-maintained infrastructures
(maintenance of buildings, hardware, software,
transportation, utilities)
c) Suitable and well-maintained work environment (5S
program)
d) Consider including financial management in your
QMSto ensure product conformity

34. • Create asurvey form which containsthese
columns:
1. Employee’sname
2. Jobposition
3. List of routine activities
4. List of non-routineactivities
5. Keyperformance indicators
6. Skills required
7. Competency assessmentper skill (use score
ratings)
8. Recommendation for training
• Employees fill in columns 1 to4
• Manager fills in columns 5 to 8
• Benefits: Manager canidentify work
redundancies, activity gaps,competency gaps,
need for training and maybe the need to re-
engineer the work processes
• Output: ?
Sometimes, work
activities are not
defined. Sothere’s
alot of confusion
Defining staff
duties and
responsibilities
and analyzing
training needsto
ensure
competence is
essential

35. Why monitor andmeasure?
• If you cannot measure it, you
cannot improve it. LordKelvin
• Measurements provide you
with abaseline to improve
upon.

36. What do youmeasure?
1. Customer satisfaction (Survey, returns rate,
complaints, lost business,etc)
2. Processconformance and effectiveness
(internal audit)
3. Processperformance (KeyPerformance
Indicators and quality objectives)
4. Product characteristics (QCinspection before
release to customer) where nonconforming
products must becontrolled

37. Internal auditprocess
• Purpose is to verify whether yourQMS
a) Conforms to your QualityPlan,
b) Conforms to ISO9001 requirements,
c) Conforms to your QMSrequirements, and
d) is effectively implemented andmaintained.
Establish
annual
audit
schedule
Distribute
Audit Plan
Perform
audit
Report
findings
Follow-up
actions

38. Auditdefined
• Audit is asystematic and documented process for
gathering audit evidence and evaluating it against the
audit criteria to determine whether it hasbeen fulfilled
• Audit criteria is aset of policies, proceduresor
requirements
• Audit evidence is records, statements offact or other
information which are relevant to the audit criteria
and verifiable
• Audit conclusion is the outcome of an auditprovided
by the audit team after consideration of the audit
objectives and all audit findings

39. What do youanalyze?
• Analyzewhat youmeasured:
a) Customer satisfaction levels
b) Internal audit results
c) Product QCinspectionresults
d) KPIresults
e) Suppliers’performance.

40. What toimprove?
• Theorganization shall continually improve the
effectiveness of the qualitymanagement system
through the useof the quality policy, quality
objectives, audit results, analysis of data,
corrective and preventive actions and
management review.
• All nonconformities require correctiveactions
• All potential nonconformities requirepreventive
actions.

41. Correctiveactionprocess
Detect
nonconformity
Report
nonconformity
Review
nonconformity
against criteria
IssueCAR
Perform root
causeanalysis
Evaluateneed
for corrective
action
Implement
corrective
action
Record the
results of
actions taken
Verify
effectiveness of
actions taken

42. Preventive actionprocess
Detect
potential
nonconformity
Report
potential
nonconformity
Reviewagainst
criteria
IssueP
AR
Perform root
causeanalysis
Evaluateneed
for preventive
action
Implement
preventive
action
Recordthe
results of
actionstaken
Verify
effectivenessof
actions taken

43. Riskanalysis
Performing arisk analysis on your
business processescanhelp you
detect potentialnonconformities
• Describe the risk
• Describe the potential effects
• Quantify likelihood of occurrence
(consider frequency)
• Quantify severity of consequence
(consider harm or damage)
• Assignrisk rating (likelihoodx
severity)
• Riskrating >4 shall be controlled
(ALARP=aslow asreasonably
practicable)
Scoreratings
1 =very low
2 =low
3 –moderate
4 =high
5 =very high

44. Root causeanalysis
Rootcause Effect Effect Directcause Nonconformity
causes effect
Sourcesof direct causes:
1. Human error,
2. Material defect,
3. Equipment malfunction,
4. Ineffective methods of operation or control, or
5. Flawed management policies.

45. Quality by Design
A systematic approach to development that begins
with predefined objectives and emphasizes product
and process understanding and process control,
based on sound science and quality risk
management

46. Quality
The suitability of either a drug substance or a
drug product for its intended use. This term
includes such attributes as the identity,
strength, and purity .

47. Significance Of QbD
 Quality by Designmeans–designing and developing
formulations and manufacturing processesto ensure a
predefined quality
 Quality by Designrequires –understanding how
formulation and manufacturing process variables influence
product quality .
 Quality by Designensures–Product quality with effective
control strategy

48. Quality by Design approach can be
used for:
 Active pharmaceutical
ingredients
 Materials including
excipients
 Analytics
 Simple dosage forms
 Advanced drug delivery
systems
 Devices
 Combination products
(e.g. theranostics)

49. What arethe stepsin a Quality byDesign
approach?
2. CRITICAL
QUALITY
A
TTRIBUTES
3. LINK
MAsANDPPs
TOCQAS
4. EST
ABLISH
DESIGN
SP
ACE
1. T
ARGET
PRODUCT
PROFILE
5. EST
ABLISH
CONTROL
STRA
TEGY
6. Risk
Assessment

50. Target Product Quality Profile
• The target product profile (TPP) has been defined as a
“prospective and dynamic summary of the quality
characteristics of a drug product that ideally will be
achieved to ensure that the desired quality, and thus
the safety and efficacy , of adrug product isrealized”.

51. Critical Quality Attributes
ACQAis aphysical, chemical, biological, or
microbiological property or characteristic that
should be within an appropriate limit, range, or
distribution to ensure the desired product quality.
CQAsare generally associated withthe
• Drug substance,
• Excipients,
• Intermediates (in-process materials) and
• Drug product.

52. Material attribute
Material:
• Rawmaterials, starting materials, reagents, solvents, process aids,
intermediates, apis, and packagingand labelling materials, ICHQ7A
Attribute:
• Aphysical, chemical, biological or microbiological propertyor
characteristic
Material attribute:
• Canbe an excipient CQA,raw material CQA,starting material CQA,
drug substance CQAetc
• Amaterial attribute canbe quantified
• Typically fixed
• cansometimes be changed during further processing (e.G. PSD–
milling)
• Examplesof material attributes: PSD,impurity profile, porosity,
specific volume, moisture level,sterility.

53. Process Parameter
 Aprocess parameter whose variability hasan impact on a
critical quality attributeand therefore should be monitored or
controlled to ensure the process produces the desired quality
(Q8R2)
 CPPshave adirect impact on theCQAs
 Aprocess parameter (PP)canbe measured and controlled
(adjusted)
 Examplesof CPPsfor small molecule:Temperature,
addition rate, cooling rate, rotationspeed
 Examplesof CPPsfor large molecule: Temperature, pH,
Agitation, Dissolved oxygen, Medium constituents, Feedtype
and rate

54. Design Space
Definition
Themultidimensional combination and interaction ofinput
variables (e.g., material attributes) and process
parameters that havebeendemonstrated to provide
assuranceof quality
 Regulatory flexibility
Working within the design spaceis not consideredachange
 Important to note
Designspaceis proposed by the applicant and is subjectto
regulatory assessmentand approval

55. Design Space Determination
 First-principles approach
◦ Combination of experimental data and mechanistic knowledgeof
chemistry, physics, and engineering to model and predict
performance
 Non-mechanistic/empirical approach
◦ statistically designed experiments (does) ◦ linear andmultiple-linear
regression
 Scale-up correlations
◦ Translate operating conditions between different scalesor piecesof
equipment

56. Control Strategy
Aplanned set of controls,
o Derived from current product and processunderstanding,
o That assuresprocessperformance and product quality.
The controls can include
Parameters and attributes related to
o Drug substance
o Drug product materials
o Components, facility
o equipment operating conditions
o In-process controls
o Finished product specifications,and
o Theassociated methods and frequency of monitoring andcontrol
(ICH10)

57. Risk Assessment
• Risk assessment : Riskis defined asthe combination
of the probability of occurrence of harm and the
severity of that harm.
• RiskAssessment –Asystematic process of organizing
information to support arisk decision to be made
within arisk management process. It consists of the
identification of hazardsand the analysis and
evaluation of risks associated with exposure tothose
hazards.

59. What is Total Quality Management ?
TQM is an approach to improving the
effectiveness and flexibilities of business as a
whole. It is essentially a wayof organizing and
involving the whole organization,
department, every activity and every single
person at every level. TQM ensures that the
management adopts a strategic overview of the
quality and focuses on prevention
rather than inspection.

60. Objectives of TQM
• Meeting the customer's requirements is the primary
objective and the key to organizational survival and growth.
• The second objective of TQM is continuous
improvement of quality. The management should
stimulate the employees in becoming increasingly
competent and creative.
• Third, TQM aims at developing the relationship of
openness and trust among the employees at all levels in
the organisation.

61. Significance of TQM
The importance of TQM lies in the fact that
it encourages innovation, makes the
organization adaptable to change, motivates
people for better quality, and integrates the
business arising out of a common purpose and
all these provide the organization with a
valuable and distinctive competitive edge.

62. Elements of TQM
• Be customer focused
It requires the company to check customers'
attitudes regularly and includes the idea of
internal customers as well as external ones.
• Do it right the first time
This means avoiding rework, i.e., cutting the
amount of defective work.

63. • Constantly improve
allows the company
Continuous improvement
gradually to get better.
• Quality is an attitude
Every one has to be committed to quality. That means
changing the attitude of the entire workforce, and
altering the waythe companyoperates.
• Telling staff what is going on
This involves improved communication. Typically, it
includes team briefing.

64. • Educate and train people
An unskilled workforce makes mistakes. Giving more
skills to workers means they can do a wider range of
jobs, and do them better. It also means educating staff in
the principles of TQM, which is a whole new style of
working.
• Measure the work.
Measurement allows the company to make decisions
based on facts, not opinion. It helps to maintain
standards and keep processes within the agreed
tolerances.
• Top management must be involved
If senior management is not involved, the programme
will fail.

65. • Make it a good place to work
Many companies are full of fear. Staffs are afraid of the
sack, their boss and making mistakes. There is no point in
running a TQM program unless the company drives out
fear.
• Introduce team work
Team work boosts employees' morale. It reduces conflict
and solves problem by hitting them with a wider range of
skills. It pushes authority and responsibility downwards
and provides better, more balanced solutions.
• Organize by process, not by function
This element of TQM seeks to reduce the barriers that
exist between different departments, and concentrates on
getting the product to the customer.

66. TQM failsbecause:
• Top management sees no reason for change.
• Top management is not concerned for its staff.
• Top management is not committed to the TQM
programme.
• The company loses interest in the programme after six
months.
Reasons for
FAILURE

67. • The workforce and the management do not agree on
what needs to happen.
• Urgent problems intervene.
• TQM is imposed on the workforce, which does not
inwardly accept it.
• No performance measure or targets are set, so
progress cannot be measured.
• Processes are not analyzed, systems are weak and
procedures are not written down.

69. • Sixsigma is abusiness statistical Strategy.
• Isto identifying defects and removing them fromthe
process of products to improvequality.
• Adefect is defined asany process output that does
not meet customerspecifications.
• Statistical measure to objectively evaluateprocesses.

70. • TheSixsigma wasfounded by Motorola in the 1970s.
• Out of senior executiveArt Sundry's criticismof
Motorola’s bad quality.
• Theyfounded aconnection between increases in
quality and decreasesin costs of production.
• Bill Smith, “Father of six sigma” introduce thisquality
improvement Methodology to Motorola.

71. • Quality management program developedby
Motorola in the1980s.
• Management philosophy focused on business
processimprovements to:
Eliminate waste, rework, andmistakes
Increase customer satisfaction
Increase profitability and competitiveness

72. DMAIC DMADV
• Define
• Measure
• Analyze
• Improve
• Control
• Define
• Measure
• Analyze
• Design
• Verify

73. Define : company must identify the customer and which type
of aproduct and hope from it. Theseare analyze by using
flow cause/effect diagrams, check sheets, paretoanalysis.
Measure : company will collect the baseline data to
determine where the process stands ascompare to where it
needs to be.And also seethe critical to quality characteristics
an estimate current process capability. Then find out the
current sigma level according to those identified
characteristic that are mostly important to the customer

74. DMAIVcont….
Analyze : this shows the amount of improvement
necessary to make the Critical to quality characteristics
the best in the industry. For this phase company use
some descriptive statistical methods like mean, mode,
median…etc.
Improve : Implement the suggested improvements in
this phase And also test possible solutions to the
process problem. Collect data from the all possible
solutions and test them on a small scale and run a
cost/benefit analysis of implementing the solution.
Then choose the best solution and create a plan for
implement the solution.

75. 8
Improvementcycle
• PDCAcycle
Plan
Do
Check
Act

76. DMAIVcont….
Control : measuresareimplemented to ensure improvements
are maintained. Tomonitor the process improvements,
basicallyusetools like statistically process control charts.
Thesecharts havethree limits, thecenter line for the average.
Monitor the processto ensurethat the processisin the
controllimits.

77. This method is alsocalled DFSS (Design ForSix Sigma)
And have fivephases,
Define design goals that are consistent withcustomer
demands and the enterprisestrategy.
Measure and identify CTQs(characteristics that
are Critical ToQuality), product capabilities,production
process capability, andrisks.
Analyze to develop and design alternatives, createa
high-level design and evaluate design capability to
select the bestdesign.

78. • Design details, optimize the design, and plan for design
verification. Thisphase may require simulations.
• Verify the design, set up pilot runs, implement the production
process and hand itover to the process owner(s).
DMADVcont….

79. 68.3% (about two
thirds)
95.5% (about 95%)
Between -1 and +1
Standard Deviation
Between -2 and +2
Standard Deviation
Between -3 and +3
Standard Deviation
99.7%

80. •Executive Leadership (CEOand other top level
managers)
•Champions (act asthe leaders of black belts.And
also )
•Master Black Belts (chosen by champions, give
their full effort to six sigma. Help to champions
and guide the Black belts and greenbelts).
•Black belts (working under Master Black
Belts, they are applying six sigma tospecific
projects).
•Green Belts (Working under the blackbelts).

81. ImplementedMethodologies
TotalQuality
Management
Zerodefects QualityControl

83. Focusof SixSigma
• Accelerating fast breakthrough
performance
• Significant financial results in 4-8months
• Ensuring SixSigmais an extension of the
Corporate culture, not the program ofthe
month
• Results first, then culturechange!

84. Handling OOS
(Out of Specification)

85. The result obtained out of defined test limit is called
out of specification.
USFDA guideline “Investigating Out of Specification
(OOS) Test Results for Pharmaceutical Industry”
Published by CDER in Oct 2006.
Quality unit should have well define SOP for OOS
The scope of SOP should be well define

86. Event Year
USFDA audited Barr Laboratory, identified attempt
of “Test until pass “ and other abnormality,
Resulted in 483
1989/1991/
1992
FDA prosecuted Barr Laboratory, Court directed to
FDA to draft the OOS guidelines
Feb 1993
FDA generated draft OOS guideline Sept 1998
FDA published final OOS guideline Oct 2006

87. OOS Investigation
Laboratory Investigation
Must be
• Thorough
• Timely
• Unbiased
• Well documented
• Scientifically sound

88. OOS Investigation –(Phase I)
Laboratory Investigation
Check list to identify obvio.us Laboratory error
1. Analyst qualification and training on intended work
2. Correctness Test specification and Method
3. Instrument calibration or performance
4. Preparation test solutions and dilutions
5. Validity of Reagents and standards
6. Performance of system suitability
7. Correctness of calculation and etc….

89. OOS Investigation –(Phase I)
Laboratory Investigation
If Analyst Error identified,.it should be
• logical and appropriate
• not on hypothetical basis
Identify appropriate assignable cause for Laboratory error
Correct the error, and repeat the analysis to invalidate the
OOS.
Suggest the Corrective and Preventive actions e.g. training
to the Analyst, Requalification of Analyst etc. whatever the
scientifically appropriate.

90. OOS Investigation –(Phase II)
Extended Investigation
If No assignable cause fou.ndin phase I investigation,
Phase II investigation should be initiated
• Retesting of Material with other analyst (n≥ 3)
• Resampling and testing
• Investigation at Plant
• Further Extend investigation (upon rejection)

91. Tool for OOS Investigation &
Related Corrective and Preventive
action

92. 5M –Tool to Identify the Route cause
Man
Machine
Material
Method
Movement

93. Target the suspect
Use 5 why technique to reach at root cause
Ask Why, Why, Why, Why and Why five times and try to
reach at more probable reason
To check the reason scientifically sound - Process each
reason with six sigma technique -DMAIC

94. Six sigma technique (DMAIC)
Define
Measure
Analyze
Improve
Control

95. Draw appropriate root cause.
Root cause should be logical and scientific.
Collect the historical evidence if any with same process or any
other process in the plant.
Identify the need for extend the investigation to past or future
batches…
Provide corrective action with evidence
Suggest preventive action
( corrective action should be reviewed against similar process in
the plant for no impact)
Conclude the activity in timely manner.

96. NATIONAL ACCREDITATION BOARD
FORTESTINGAND CALIBRATION
LABORATORIES
(NABL)

97. What is
NABL ?
NABL specifies the general
requirements for t
h
e competence to
carry out tests and calibrations,
including sampling. It covers testing
and calibration performed using
standard methods, non-standard
methods, and laboratory-developed
methods.

98. Benefits of
Accreditation:
Potential increase in business due to enhanced
customer confidence and satisfaction.
Savings in terms of time and money due to
reduction or elimination of the need for re-testing .
Better control of laboratory operations and
feedback to laboratories as to whether they have
sound Quality Assurance System and are
technically competent.

99. Increase of confidence in Testing / Calibration data
and personnel performing work.
Customers can search and identify the laboratories
accredited by NABL for their specific requirements
from the directory of Accredited Laboratories.
Users of accredited laboratories will enjoy greater
access for their products, in both domestic and
international markets, when tested by accredited
laboratories.

100. Types of Laboratory can seek
Accreditation:
Laboratories undertaking any sort of testing
or calibration in the specified fields.
Private or government laboratories.
Small operations to large multi-field
laboratories.
Site facilities, temporary field
operations and mobile
laboratories.

101. TESTING LABORATORIES CALIBRATION LABORATORIES MEDICAL LABORATORIES
 Biological
 Chemical
 Electrical
 Electronics
 Fluid-Flow
 Mechanical
 Non-Destructive Testing
 Photometry
 Radiological
 Thermal
 Forensic
 Electro-Technical
 Mechanical
 Fluid Flow
 Thermal & Optical
 Radiological
 Clinical Biochemistry
 Clinical Pathology
 Haematology &
Immunohaematology
 Microbiology & Serology
 Histopathology
 Cytopathology
 Genetics
 Nuclear Medicine (in-vitro
tests only)
PROFICIENCY TESTING PROVIDERS REFERENCE MATERIAL
PRODUCERS
 Testing
 Calibration
 Medical
 Inspection
 Chemical Composition
 Biological & Clinical Properties
 Physical Properties
 Engineering Properties
 Miscellaneous Properties

102. 10Step Approach To
Accreditation
Awareness Training
Quality Policy & ObjectivesFinalization
Gap Analysis
Documentation / Process Design
Documentation / Process Implementation
Internal Audit
Management Review Meeting
Shadow Audit
Corrective –Preventive Actions
Final Certification Audit

103. Step 1:-Awareness
Training
Separate training sessions for top
management, middle management
and junior level management.
Creates a motivating environment
throughout t
h
eorganization for ISO
17025 implementation.

104. Step 2:-Quality Policy &
Objectives
Work shop with top management on
development of quality policy.
Work shop with top management
and middle l
e
v
e
l functional
management on development of
quality objectives.

105. Step 3:-Gap
Analysis
Understanding of all the
operations of the
organization.
Development of process map for the
activities of the organization.
Comparing existing operations with
requirements of ISO 17025:2005
standard.

106. Step 4:-Documentation
/ Process Design
Quality Manual
Functional Procedures
WorkInstructions
SystemProcedures
Formats

107. Step 5:-Documentation / Process Implementation
Work–shop on process / document
implementation as per ISO 17025 requirements.
Departmental / Individual assistance in
implementing the new processes /
documents.

108. Step 6:-Internal Audit
Internal Audit Training & Examination(Optional).
Successful employees / we carry out internal a
u
d
i
t
of the organization covering all the
departments and operations.
Suggest corrective and preventive actions for
improvements in each of the audited
departments.

109. Step 7:-Management Review Meeting
Quality Policy & Objectives
Results of internal audit
Results of supplier evaluation
Results of customercomplaints
Results of customer feedback etc.

110. Step 8:-Shadow Audit
A replica of final certificationaudit.
Finds degree of compliance with ISO
17025 standard.
Gives an idea to the employees about the
conduct of the final certification audit.

111. Step 9:-Corrective –Preventive Actions
On the basis of shadow audit conducted in
the last step, all the non-conformities will be
assigned corrective and preventive actions.
A check will ensure that all the NCs are closed
a
n
dthe organization is ready for the final
certification audit.

112. Step 10:-Final Certification Audit
Upon completion of various stages of
accreditation audit, the audit, your
organization will be awarded accreditation.

113. GOOD LABORATORY
PRACTICES

114. GLP: GOOD LABORATORY PRACTICE
• GLP is an FDA regulation.
• GLP is a formal regulation that was created
by the FDA (United states food and drug
administration) in 1978.

115. Definition of GLP
• GLP embodies a set of principles that
provides a frame work within which
laboratory studies are planned
performed, monitored, and archived
and reported.

116. WHY WAS GLP CREATED?
• In the early 70’s FDA became
aware of cases of poor
laboratory practice all over the
United States.
• They discovered a lot
fraudulent activities and a lot
of poor lab practices.
• Examples of some of these
poor lab practices found were
1. Equipment not been
calibrated to standard form ,
therefore giving wrong
measurements.
2. Incorrect/inaccurate accounts
of the actual lab study.
3. Inadequate test systems.

117. Purpose of GLPs:
• GLPis to certify that every step of the
analysis is valid or Not.
• Assure the quality &integrity of data
submitted to FDA in support of the
safety of regulatedproducts.
• GLPs have heavy emphasis on data
recording, record & specimen retention.

118. GOOD LABORATORY PRACTICES PRINCIPLES.
1. Test Facility Organisation and Personnel.
2. Quality Assurance Programme(QAP).
3. Facilities.
4. Apparatus, Material and Reagents.
5. Test systems.
6. Test and Reference Substances.
7. Standard Operating Procedures(SOP).
8. Performance of The Study.
9. Reporting of Study Results.
10. Storage and Retention of Records and materials.

119. 1.Test Facility Organizationand Personnel
Study Personnel Responsibilities
• Should have the Knowledge of the GLP
principles.
• Access to the study plan and appropriate
SOP’s.
• Comply with the instructions of the SOP’s.
• Record raw data.
• Study personnel are responsible for the quality
of theirdata.
• Exercise health precautions to minimize risk.
• Ensure the integrity of the study.

120. 2.Quality Assurance Program
Responsibilities of the QA Personnel
• Access to the updated study plans and SOP’s.
• Documented verification of the compliance of study
plan to the GLP principles.
• Inspections to determine compliance of the study with
GLPprinciples.
• Three types of inspection.
– Study-based inspections.
– Facility-based inspections.
– Process-based inspections.
• Inspection of the final reports for accurate and full
description.
• Report the inspection results to the management.
• Statements.

121. 3. Facilities
• Suitable size, construction and location.
• Adequate degree of separation of the
different activities.
• Isolation of test systems and individual
projects to protect from biological
hazards.
• Suitable rooms for the diagnosis,
treatment and control of diseases.
• Storage rooms.

122. 4. Apparatus, Materials and Reagents
• Apparatus of appropriate design and
adequate capacity.
• Documented Inspection, cleaning,
maintenance and calibration of apparatus.
• Apparatus and materials not to interfere
with the test systems.
• Chemicals, reagent and solutions should be
labeled to indicate identity, expiry and
specific storage instructions.

123. 5. Test Systems
• Physical and chemical test systems.
• Biological test systems.
• Records of source, date of arrival,
and arrival conditions of test systems.
• Proper identification of test systems in
their container or whenremoved.
• Cleaning and sanitization of containers.
• Pest control agents to be documented.

124. 6. Test and Reference Items
• Receipt, handling, sampling and storage
• Characterization.
• Known stability of test and reference
items.
• Stability of the test item in its vehicle
(container).
• Experiments to determine stability in
tank mixers used in the field studies.
• Samples for analytical purposes for
each batch.

125. 7.Standard Operating Procedures
(SOP)
Written procedures for a laboratories
program.
They define how to carry out protocol-
specified activities.
Most often written in a chronological
listing of action steps.
They are written to explain how the
procedures are suppose to work.

126. 7.SOP’
s
Routine inspection, cleaning,
maintenance, testing and calibration.
Actions to be taken in response to
equipment failure.
Keeping records, reporting, storage,
mixing, and retrieval of data.
Definition of raw data.
Analytical methods.

127. 8. Performance of the Study
• Prepare the Study plan.
• Content of the study plan.
› Identification of the study.
› Records.
› Dates.
› Reference to test methods.
› Information concerning the sponsor
and facility.
• Conduct of the study.

128. 9. Reporting of Study Results
• Information on sponsor and test facility.
• Experimental starting and completion
dates.
• AQualityAssurance Program Statement.
• Description of materials and test methods.
• Results.
• Storage (samples, reference items, raw
data, final reports) etc.

129. 10. Storage and Retention of Records
and Materials
– The study plan, raw data, samples.
– Inspection data and master
schedules.
– SOPs.
– Maintenance and calibrationdata.
– If any study material is disposed of
before expiry the reason to be
justified and documented.
– Indexof materials retained.

130. What GoodLaboratory Must Contain.?
• Area should be free from smoke, smell,
dust etc.
• Ensure good ventilation, proper
illumination and prefer natural light.
• Air conditioned the lab with humidity
control.
• Enough space for measuring and testing
instrument.

131. Cont…
• Proper arrangement of testing.
• Take care of all safety points including
proper earthing as well as fire safety.
• Avoid uncleanable spots in floors, walls,
ceiling.
• Establish proper areas for storage of incoming
samples as well as test–completed samples.
• Also provide sample collection place as
well as packing and disposal of tested
samples.

132. Do this for GLP
• Keep the things at its location after use.
• Store heavy things at bottom &if possible on
Trollies.
• Give name of location to everything.
• Follow “Everything has the place &Everything at
its place”principle.
• Prepare location list &display it.
• Put ladders for things stored on top.
• Identify everything with its name/ purpose.
• Follow “FIFO” to prevent old accumulation for
laboratory chemicals.

133. Benefits of good laboratory practices.
• It will give better image of company as a
Quality producer in Global market.
• Provide hot tips on analysis of data as
well as measure uncertainty and perfect
record keeping.
• Provide guideline for doing testing and
measurement in detail.
• Provide guidelines and bettercontrol
for maintenance of instruments,
environment control, preservation of
test records etc

134. Admire your Questions…
Thanks!!!