2. UNIT-1.2
QUALITY IN ANALYTICAL CHEMISTRY:
Quality Systems In Chemical Laboratories,
Cost And Benefits Of A Quality System,
Types Of Quality Standards For Laboratories,
Total Quality Management,
Quality Audits And Quality Reviews,
Responsibility Of Laboratory Staff For Quality.
3. Questions Asked in Examination Sem-I
Q.1. What is an internal audit? Who is responsible for internal
audit? How is it done?
Q.2. What are responsibilities of an individual members of the
staff in maintaining and Improving the laboratory’ quality
system?
Q.3. What do you mean by quality system review?
What must be reviewed in annual quality system review meeting?
Q.4. Discuss in brief, the types of management standards for
laboratories
Q.5. What is an internal audit ? Who is responsible for an
internal audit? How is it done?
Q.6. What are responsibilities of quality manager in maintaining
and improving the laboratory’s quality system?
4. Quality Systems In Chemical Laboratories
• Concept OF Quality:
• Totality of the features and characteristics of a
product or service that bears on its ability to
satisfy the given needs.
• Quality Control: It refers to active measures
taken to ensure the accuracy and precision of
analytical results.
• Quality Control is based on a written standard
operating procedure that specifies exactly what
steps are followed from collection of sample all
the way to how to calculate results from raw data.
5. Quality Assurance
It refers to all procedures ,data, and documents
required to produce reliable analytical results
and to demonstrate that results are accurate
and precise.
For Ex. Calibration curve is linear, Appropriate
blanks give expected low signals and replicate
analysis are reproducible.
Documentation of the sample are preserved
properly.
6. Various Definition of Quality
Product
Based
• It implies the presences of ingredients and
properties as per the requirements.
User Based
• It implies capacity to satisfy costumer.
Manufactures
Based
• It implies the conformance to the requirements
Value based
• Degree of excellence as an acceptable price and the
control of variability at an acceptable cost.
7. Costumer based Defination of
Quality
1. It is the key attribute the costumers
use to evaluate product or services.
2.Quality is every thing that every one
does to satisfy the costumer.
3. Quality is achieving and exceeding
the expectation of the costumer to
provide business for the future.
8. Parameters that decides Quality
from the costumers angle
Features
Durability
Features
Performance:
Performance:
9. Parameters that
decides Quality
from the costumers
angle
Performance: Expected for the product and
service
Features : Supplementing the basic
function of the product
Reliability : Performance of the product or
the service for the stipulated period
Conformance : Degree of closeness between
the operating characteristics of the product
Durability : Measure of the product life
Serviceability : Speed, competence and
degree of satisfaction
Aesthetics : It is subjective parameter
10. Quality Assurance
QUALITY ASSURANCE (QA):
QA describes the overall measures
that a laboratory uses to ensure
the quality of its operations.
Typically this
include the following
parameters
11. Quality Assurance
1 • A quality system
2 • Suitable laboratory environment
3 • Educated, trained and skilled staff
4 • Training procedures and records
5 • Equipment suitably maintained and calibrated
6 • Quality control procedures
7 • Documented and validated methods
8 • Traceability and measurement uncertainty
13. Total Quality Management
The goal is costumers satisfaction
TQM is an Integration of all functions
and processes within the organization in order
to achieve continuous improvement of
the quality goods and services .
18. Cost and Benefit of Quality System
Cost of Quality System:
i) Initial cost of quality system will depend on how much work
the laboratory needs to do bring itself up to quality standard to
adopt.
ii) Once the Standard is adopted the operating cost is in the range
of 5-10 % of total cost.
iii) The initial resource requirement is efforts required to agree
the quality system and preparation of quality manual .
iv) The preparation of quality manual takes several months
accordingly number of staff involved and the salary expenses
incurred for the staff.
v) As part of the Quality System , Quality Manger should be
appointed and the cost increases because of appointment of
Manger .
19. vi) As part of the Quality System, the laboratory will need
to operate its own internal system of quality assurance.
vii) The quality assurance include following activities
such as
a) Quality assurance trials, b) Replicate testing, c) Control
charting, d) Validating methods,
e) Obtaining and using suitable reference materials and regular
analysis of blank and standards.
All the essential activities represent an additional cost to the
laboratory.
vii) Finally if Laboratory wishes to be accredited by an
external Organization (Like ISO) the various third party
organization bodies AND the fees of Third party
accreditation will increase the cost on quality system .
20. 1) Bigger is a laboratory more complex is its procedure
which makes misunderstanding and mistake, some time
absence of member of staff who is on holiday or ill can
cause confusion. But if operating system is established as
part of quality system mistakes can be reduced.
2) Any Laboratory / organization which develops its
reputation for producing reliable product has a major
advantage over rival Laboratory/ organization.
3) Reliability of Laboratory’s result
4) Quality system of Laboratory and its third party
accreditation can be used by laboratory for positive
advertisement for their services.
5) Any organization which develops its reputation for
producing reliable product has a major advantage over
rival organization.
Benefit of Quality System:
21. 5) Costumers satisfaction and increasing of business of Laboratory
6) Clarification of what services a client expects the practice to provide;
7) Reduction in loss of time due to re-work or ineffective and/or
inefficient practices;
8) Better communications structure;
9) Higher repeat business/referrals from a satisfied client base;
10) Problems are highlighted and resolved in an open manner;
11) Increased confidence that controls are in place and the risk of
error is reduced;
12) Training for staff in performing their roles;
13) Acceptance by government and the community of the concept of
self-regulation of the accounting profession and its effectiveness.
14) Benefits to the Clients and the Community are higher quality
service; and increased reliability of the end product.
22. Types of Laboratory
Standards For
Laboratories
Good Laboratory
Practices
International and
National standards of
Organization
ISO 9000
series
Europe EN 29000
series and
EN 45000
British Standard
Institution BS 5750
National
Accreditation Board
for Laboratory
NABL India
BIS
Bureau of Indian
Standard
Types of
Laboratory
Standards
For
Laboratories
23. AUDIT AND REVIEW
In practice quality audits take two forms.
An audit carried out by an independent external body
as part of the accreditation process is more usually
known as an assessment. (external audit.)
“Quality audits” carried out within the laboratory, are
sometimes subdivided into audit, often called ‘internal
audit’, (which checks that the quality procedures are in
place, and fully implemented) .(Internal Audit)
Review which checks to ensure that the quality system
is effective and achieves objectives.
The review is carried out by senior management with
responsibility for the quality policy and work of the
laboratory.
24. Quality Audits And Quality Reviews,
An important aspect of quality management is the
periodic re-examination of the quality system by the
laboratory's own management.
In general, all aspects of the quality system should be
examined at least once a year.
The system should be examined in two ways.
Firstly, it should be examined to ensure that it is
sufficiently well documented to enable adequate and
consistent implementation, and that staff are actually
following the system described.
This examination is commonly known as auditing (as
opposed to the external auditing or assessment carried
out by accreditation or certification bodies).
25. • Secondly, the system should be examined to see
whether it meets the requirements of the laboratory, its
customers and, if appropriate, the quality management
standard.
• Over a period of time the needs of the laboratory and its
customers will change and the quality system should
evolve to continue to fulfill its purpose.
• This second type of examination is commonly known
as review and should be carried out at least annually.
• It is carried out by the laboratory management and
draws on information from a number of sources,
including results from internal audits, external
assessments, proficiency testing scheme participation,
internal quality control studies, market trends,
customer complaints and compliments, etc.
26. • The programme of audits and review is
normally co-ordinated by the laboratory
quality manager, who is responsible for
ensuring that auditors have the correct training,
guidance and authority necessary for their
work.
27. A check list, detailing the aspects of a chemical laboratory
which should be examined during a quality audit .
1. Staff
i) Staff have the appropriate blend of background, academic
or vocational qualifications, experience and on-the job
training for the work they do.
ii) On-the-job training is carried out against established
criteria, which wherever possible are objective. Up-to-
date records of the training are maintained.
iii) Tests are only carried out by authorized analysts.
iv) The performance of staff carrying out analyses is
observed by the auditor.
28. 2. Environment
i) The laboratory environment is suitable for the work carried
out.
ii) The laboratory services and facilities are adequate for the
work carried out.
iii) There is adequate separation of potentially conflicting
work.
iv) The laboratory areas are sufficiently clean and tidy to
ensure the quality of the work carried out is not
compromised.
v) There is adequate separation of sample reception,
preparation, clean-up, and measurement areas, to ensure
the quality of the work carried out is not compromised.
vi) Adherence to safety regulations is consistent with the
requirements of the quality management standard.
29. 3. Equipment
i) The equipment in use is suited to its purpose.
ii) Major instruments are correctly maintained and records of this maintenance
are kept.
iii) Appropriate instructions for use of equipment are available.
iv) Critical equipment, e.g. balances, thermometers, glassware, timepieces,
pipettes etc. are uniquely identified, appropriately calibrated (with suitable
traceability), and the corresponding certificates or other records
demonstrating traceability to national measurement standards are available.
v) Calibrated equipment is appropriately labeled or otherwise identified to
ensure that it is not confused with uncalibrated equipment and to ensure
that its calibration status is clear to the user.
vi) Instrument calibration procedures and performance checks are documented
and available to users.
vii) Instrument performance checks and calibration procedures are carried out
at appropriate intervals and show that calibration is maintained and day-to-
day performance is acceptable. Appropriate corrective action is taken
where necessary.
viii) Records of calibration, performance checks and corrective action are
maintained
30. 4. Methods and Procedures
i) In-house methods are fully documented,
appropriately validated and authorised for use.
ii) Alterations to methods are appropriately
authorised.
iii) Copies of published and official methods are
available.
iv) The most up-to-date version of the method is
available to the analyst.
v) Analyses are (observed to be) following the
methods specified.
vi) Methods have an appropriate level of advice on
calibration and quality control.
31. Chemical and Physical Measurement Standards, Certified
Reference Materials and Reagents.
i) The measurement standards required for the tests are readily
available.
ii) The measurement standards are certified or are the "best" available.
iii) The preparation of working measurement standards and reagents is
documented.
iv) Measurement standards, reference materials and reagents are
properly labeled and correctly stored. Where appropriate
“opening” and “use-by” dates are used.
v) New batches of measurement standards, and reagents critical to the
performance of the method are compared against old batches
before use.
vi) The correct grade of materials is being used in the tests.
vii) Where measurement standards, or reference materials are
certified, copies of the certificate are available for inspection.
32. 6. Quality Control
• i) There is an appropriate level of quality control for each test.
• ii) Where control charts are used, performance has been maintained within
acceptable criteria.
• iii) QC checksamples are being tested by the defined procedures, at the
required frequency and there is an up-todate
• record of the results and actions taken where results have exceeded action
limits.
• iv) Results from the random re-analysis of samples show an acceptable
measure of agreement with the original
• analyses.
• v) Where appropriate, performance in proficiency testing schemes and/or
inter-laboratory comparisons is
• satisfactory and has not highlighted any problems or potential problems.
• vi) There is an effective system for linking proficiency testing performance
into day-to-day quality control.
33. • i) There is an effective documented system for
receiving samples, identifying samples against
requests for analysis, showing progress of
analysis, issue of report, and fate of sample.
• ii) Samples are properly labeled and stored.
7. Sample Management
34. 8. Records
i) Notebooks/worksheets or other records show the
date of test, analyst, analyte(s), sample details,
test observations, quality control, all rough
calculations, any relevant instrument traces, rough
data, and relevant calibration data.
ii) Notebooks/worksheets are indelible, mistakes are
crossed out rather than erased or obliterated, and
the records are signed by the analysts.
iii) Where a mistake is corrected the alteration is
traceable to the person making the correction.
iv) The laboratory has procedures for checking data
transfers and calculations and is using them.
35. • 9. Test Reports
• i) The information given in reports is
consistent with the requirements of the
standard, the customer and reflects any
provisions made in the documented method.
• 10. Miscellaneous
• i) Documented procedures are in operation to
handle queries and complaints and system
failures.
37. Responsibility Of Laboratory Staff
For Quality.
1.
Laboratory
Management
2.
Quality Manager
3.
Members of staff
Q. What are responsibilities of Laboratory
Management or Quality manager or Individual
members of staff in maintaining and improving the
laboratory’s quality system?
38. 1. Laboratory Management
1) The management of a laboratory has the initial responsibility
of deciding on the Laboratory’s Quality Policy and selecting
appropriate standards for Laboratory to adopt.
2) They should make available the resources that is necessary
to adopt standard into practice.
3) They should appoint qualified and experienced Quality
Control Manager.
4) The Laboratory quality system should be prepared in the
form of A Quality Manual and Management should approve
it as written details of how their quality policy is put into
practice.
5) The Laboratory management has to carried out perodic
examination of laboratory Quality system and Quality
system review Meeting
6) To supply the resources necessary to maintain the quality
system at the required level.
39. Responsibility Of Quality Manager For Quality.
Quality manager is the mainly responsible for quality issue.
Quality manager is therefore responsible for ensuring
laboratory staff are familiar with the requirement of laboratory
standard’s.
Quality manager is also responsible for drawing up and
maintaining the quality manual.
Quality manager has to organize laboratory system of quality
audit and quality review.
Quality manager prepares all the relevant material for
consideration at the quality system review meeting.
Quality manager also responsible for liaising with the
accreditation body and for making necessary arrangement for
periodic assessment visits to the laboratory
40. Responsibility Of Individual Members of staff For
Quality.
All members of staff are responsible for ensuring that
they are familiar with the quality system as set out in
quality Manual and any supporting documentation.
Members are expected to follow the procedures set
out in the quality Manual.
41. Types of Laboratory
Standards For
Laboratories
Good Laboratory
Practices
International and
National standards of
Organization
ISO 9000 series
Europe EN 29000
series and
EN 45000
British Standard
Institution BS 5750
National
Accreditation Board
for Laboratory NABL
India
BIS
Bureau of Indian
Standard
Types of
Laboratory
Standards
For
Laboratories
42. Good Laboratory Practices
• The organization of Economic Co-operation
and Development (OECD) which has
developed Good Laboratory Practices called
as GLP.
• International and National standards of
Organization
• Every country has its own standards relevant
to analytical Laboratory.
