Section No. 0.1 Release Authorization
This Quality Manual is released under the authority of
Dr. ------------------------------ (Director)
and is the property of
------------------------------.
Section No. 0.2 Amendment Record
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Section No./Clauses/Para /Line |
Date of Amendment |
Amendment made |
Reasons of Amendment |
Signature of person authorizing Amendment |
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Section |
Contents |
Page |
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00 |
Front Page |
01 |
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0.1 |
Quality Manual
Release Authorization |
01 |
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0.2 |
Amendment sheet |
01 |
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0.3 |
Contents |
01 |
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1 |
Scope |
01 |
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2 |
References |
01 |
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3 |
Terms and definitions |
05
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3.1 |
Abbreviations |
01 |
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3.2 |
Distribution List |
01 |
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3.3 |
Introduction |
02 |
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3.4 |
Quality Objectives |
01 |
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4 |
Management Requirement
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4.1 |
Organization |
02 |
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4.2 |
Management System |
02 |
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4.3 |
Document Control |
02 |
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4.4 |
Review of
requests, tenders and contracts |
01 |
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4.5 |
Subcontracting of
tests and calibrations |
01 |
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4.6 |
Purchasing,
Services and Supplies |
01 |
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4.7 |
Service to the
Customer |
02 |
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4.8 |
Complaints |
01 |
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4.9 |
Control of
nonconforming testing and/or calibration work |
02 |
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4.10 |
Improvements |
01 |
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4.11 |
Corrective Action |
01 |
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4.12 |
Preventive Action |
02 |
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4.13 |
Control of Records |
02 |
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4.14 |
Internal Audit |
01 |
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4.15 |
Management Review |
02 |
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5 |
Technical Requirements
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5.1 |
General |
01 |
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5.2 |
Personnel |
02 |
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5.3 |
Accommodation and
Environmental Conditions |
02 |
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5.4 |
Test Methods and
method validation |
04 |
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5.5 |
Equipment |
02 |
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5.6 |
Measurement
Traceability and Calibration |
02 |
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5.7 |
Sampling |
01 |
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5.8 |
Handling of test
and calibration items |
01 |
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5.9 |
Assuring the
Quality of Test |
01 |
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5.10 |
Reporting of
results |
03 |
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Annexure 1 |
Responsibility and
Authority |
02 |
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Annexure 2 |
Organization Chart |
01 |
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Annexure 3 |
Quality Policy |
01 |
DTL | Drug Testing Laboratory |
PTL | Pesticide Testing Laboratory |
NABL | National Accreditation Board for Testing and Calibration Laboratories |
NPL | National Physical Laboratory |
QM | Quality Manager |
TM | Technical Manager |
ICAR | Indian Council of Agricultural Research |
APEDA | Agricultural Processed Food Products Export Development Authority |
FAO | Food and Agriculture Organization |
WHO | World Health Organization |
MRM | Management Review Meeting |
ISO | International Organization for Standardization |
BIS | Bureau of Indian Standards |
NC | Non-conformity |
MSP | Management System Procedure |
STP | Standard Technical Procedure |
PT | Proficiency Testing |
ILC | Inter Laboratory Comparison |
IARI | Indian Agricultural Research Institute |
SOP | Standard Operating Procedure |
WI | Work Instruction |
APLAC | |
SI | System International |
FIFO | First in First out |
HOD | Head of Department |
HRD | Human Resource Development |
QA | Quality Assurance |
QM | Quality Manual |
QMS | Quality Management System |
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Controlled Copy No. |
Name /Designation
of the holder of controlled copy |
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Master Copy |
Quality Manager |
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01 |
Director/Chairman |
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02 |
Technical Manager |
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03 |
NABL Assessor |
Front Page : It includes Title of "Quality manual" of lab name "------------" Address" email, website, Issue No. and Issue Date:
(Lab name) incepted in the year (-------). It is engaged in providing highly reliable and cost-effective Laboratory Testing Services. In addition to this, it undertake ------------- at their advanced facility. Their services encompass Pesticide Testing, Chemical Testing, Microbiology Testing Services, -----------. Furthermore, we render ----------------- and Material Testing Services, among others. Being a government-approved DTL or PTL, we are known for responsibly carrying out testing of various materials.
We, Drug/Pesticides Testing Lab
of, ……………are committed to provide high quality of testing services by meeting
all customers' requirements; as per regulatory, statutory and relevant
national/international standards.
We ensure that our timely
services are carried out by qualified and trained personnel with high degree of
operational integrity and demonstrated skills of testing for pesticide residues
in foods and agricultural products. To attain excellence in all areas, we maintain an
effective ‘Quality Management System’,
conforming to the requirements of the ISO 17025:2017 standard, apply good
professional practices and committed for continual improvement of the
management system.
All personnel concerned with
testing activities within the laboratory familiarize themselves with the
quality documentation and implement the policies and procedures in their work.
Total customer satisfaction will be achieved
through implementation of the policies and procedures documented in the ‘Quality Management System’ by every
individual concerned.
|
Sr. No. |
Group
of products, materials or items tested |
Specific
test or types of test performed |
Specification,
standard (method) or technique used |
Range of
testing/ Limit
of detection |
MU (+/- ) |
·
Monitoring
of timely delivery of test results.
·
Monitoring
and measuring the data for the continual improvement.
·
Participation
in Proficiency Testing and/or Inter Laboratory Comparison Program to ensure the validity of test
results.
·
Continual
up gradation of skills and technologies through need based training of the identified personnel of
the laboratory.
· To extend accreditation to more products testing.
The
overall objectives are established and reviewed during the management review
meeting.
JOB
RESPONSIBILITIES AND AUTHORITIES
Director
a) To chair Management review meetings and
take policy decisions.
b) Nominate the Quality Manager and
Technical Manager of PTL/DTL.
c) Provide resources and required
infrastructural facilities to achieve the quality objectives set by the
laboratory.
d) Ensure the establishment of the System and to approve the apex document of the laboratory; Quality Manual.
e)
Review and approval of improvements in the
management system.
Quality Manager (QM)
a) QM is responsible for ensuring the
establishment, documentation implementation and maintenance of the management
system. He has direct access to the highest level of the management.
b) Prepare all the management system
documents and issue the latest revisions of all the documents to the personnel
concerned.
c)
Organize
internal audits to assess the degree of implementation of the management system
d) Interact with all the regulatory and
statutory bodies (WHO, FAO, FDA, MFPO, AOAC, BIS etc.)
e) Interact with the accreditation body and
serve as Management Representative of the Laboratory.
f) Co-ordination of in-house training
program requirements and maintaining their records.
g) Organize the management review meetings
and to give feedback on the performance of the laboratory with respect to the
management system implementation during the review meeting.
h) Ensure the availability of required
infrastructural facilities and resources to perform the testing activities
through the top management.
i) Ensure and maintain the confidentiality
j) Satisfactory resolution of customer
complaints.
k)
To
liaison with customers and suppliers.
l)
Discharge
all non-conforming testing works effectively.
m)
To
implement the corrective actions and to initiate preventive actions.
n) Resumption
of any halted job on completion of satisfactory corrective action and removal
of non conforming work.
o) Overall responsibility of the
implementation and maintenance of the management system within the laboratory.
p) He has access to the highest level of
the top management at which decisions are made for laboratory policy and
resources.
q) Halting any testing work on observation
of non conforming work
r) Sending monthly test reports to the
customers.
Technical Manager (TM)
a)
The
Technical Manager has overall responsibility of all the technical operations of
the laboratory.
b)
Selection
of the test methods
c)
To
authorize the relevant personnel to perform the tests and to monitor and
evaluate the tests performed.
d)
Provide
adequate supervision to the contractual employees/trainees
e)
Identify
the training needs and ensure the constant updating of the skills
f)
Evaluate
the effectiveness of the trainings imparted to the personnel
g)
Monitor
the sampling activity
h) To establish the quality control
program and evaluate the laboratory’s performance.
i)
Reviews
the technical procedures and test methods for their continuing suitability for
the purpose.
j)
Validation
of the methods and personnel (assessment of testing capabilities of the
personnel)
k)
Liaison
with quality manager in relation to management system matters affecting the
test results.
l)
One
of the authorized signatories to issue the test reports
m)
Assist
the Quality Manager in giving the opinions and interpretation of test results
if required.
n)
To
assist and report Quality Manager in all aspects.
o)
Member
of Management Review Committee.
p)
Halting
of any job on observation of nonconforming work
q)
Resumption
of any halted job on completion of satisfactory corrective action and removal
of non conforming work.
Laboratory Assistant
a)
To
maintain the stock register & make purchase orders as per the indent
b)
Provide
assistance for routine analytical work of the laboratory.
c)
Comply
with NABL and ISO/IEC 17025: 2017 standard requirements
d)
To
raise the purchase requirement depending upon stock availability of chemicals
and glassware.
Laboratory Attendants
a)
To
ensure that the laboratory and equipment are kept clean.
b)
To
clean glassware’s and other apparatus
c)
To dispose
off waste materials as directed.
d)
To
carry out any other work instruction given by the senior staff members of the
laboratory.
1.1 General
The Pesticides/Drug Testing
Laboratory of -------------------has adopted International Standard, ISO
17025:2017 which specifies the requirements for a Quality Management System in
order to specify the general requirements for the competence to carry out
tests, including sampling
The established system is
applicable to the activities of the organization having their Laboratory located
at ………... The scope of implementation of
this standard is as given below:
Laboratory: “Chemical
Testing”
1.2 Application
All Quality Management
System requirements laid down in International Standard ISO 17025:2017 are
applicable to the………………………………...
1. REFERENCES
The List of References
which include Standards, Manuals, Procedures and applicable product Regulatory
Requirements used in developing and implementing the systems are given below:
Standards :
NABL 100 : General information Brochure
NABL 103 : Guidelines and specific criteria for
Chemical testing laboratories
NABL 160 : Guide for prepare a Quality Manual
SANCO/10684/2009 – Method Validation and Quality Control Procedures
for Pesticide Residue Analysis in Food and Feed
Official Journal of the European Communities L221/8.
Commission decision of 12 August 2002, implementing Council Directive 96/23/EC
concerning the performance of analytical methods and the interpretation of
results. 2002/657/EC
Selection, use and interpretation
of proficiency testing (PT) schemes by laboratories - 2000
2. Regulatory
Requirements (Related to laboratory processes)
Nil
3. Procedures
QUALITY
SYSTEMS PROCEDURES
S.No. DOC NO. DETAILS
1. PTL/QSP/01 Procedure for Customer Confidential
Information and Proprietary Rights
2. PTL /QSP/02 Procedure for Document & Data Control
3. PTL /QSP/03 Procedure for Purchasing, Services and
Supplies
4. PTL /QSP/04 Procedure for Service to the Customer
5. PTL /QSP/05 Procedure for Customer Complaints
6. PTL QSP/06 Procedure for Control of Non-Conforming
Testing.
7. PTL /QSP/07 Procedure for Improvement
8. PTL /QSP/08 Procedure for Corrective Action
9. PTL /QSP/09 Procedure for Preventive Action
10. PTL /QSP/10 Procedure for Control of Records
11 PTL /QSP/11 Procedure for Internal Audit
12 PTL /QSP/12 Procedure for Management Review
13 PTL /QSP/13 Procedure for Training
14 PTL /QSP/14 Procedure for Housekeeping
15 PTL /QSP/15 Procedure for Estimation of Uncertainty of
measurement
16 PTL /QSP/16 Procedure for Equipment
17 PTL /QSP/17 Procedure for Measurement Traceability
and Calibration
18 PTL /QSP/18 Procedure for Sampling
19 PTL /QSP/19 Procedure for Handling of Test and
Calibration Items
20 PTL /QSP/20 Procedure for Assuring the Quality of Test
21 PTL /QSP/21 Procedure for Reporting of Results
22 PTL/QSP/22 Procedure for use of NABL Symbol
3.0 TERMS & DEFINITIONS
In this Quality System
Manual and related procedures / instructions, following terms / definitions and
abbreviations have been used:
3.1 Terms :
Laboratory : Laboratory
of Pesticide Residue
Supplier : The
vendors or contractors supplying the materials and / or services to company
Customer : The
Customer / end user who buys the
Services. It is also used for Internal
Customers
3.2
Definitions :
3.2.1 Accreditation body: A Governmental or non- governmental body
which conducts and administers a laboratory accreditation system and grants
accreditation.
3.2.2 Accredited laboratory: A laboratory to which accreditation
has been granted.
3.2.3 Accredited criteria: A set of requirements used by an
accreditation body which a testing /calibration laboratory must meet to be
accredited.
3.2.3 Assessor: An expert who carries out some or all functions
related to laboratory assessment.
3.2.4 Accredited laboratory test report: A test report which
includes a statement by the testing laboratory that it is accredited for the
test reported and that the test has been performed in accordance with the
conditions prescribed by the accreditation body.
3.2.5 Accepted Reference
Value:
a) A theoretical or established value based on
scientific principles.
b) An assigned value, based on experimental work of
some national or international organization.
c) A consensus value, based on collaborative
experimental work under the auspices of a scientific or engineering group.
3.2.6 Assigned
value: Estimate of true value used in the assessment of proficiency.
3.2.7 Accuracy:
The closeness of agreement between test/calibration results and the accepted reference value.
3.2.8 Auditee: An
organization to be audited.
3.2.9 Accepted reference value: A value that serves as an agreed
upon reference for comparison.
3.2.10 Accuracy of measurement: The closeness of agreement between
a test result and the accepted reference value.
3.2.11 Arithmetic mean: The sum of values divided by the number of
values.
3.2.12 Bias: The difference between the test results and an
accepted reference value.
3.2.13 Calibration: The set of operations which establish, under
specified conditions, the relationship between values indicated by a measuring
instrument or system or values of a measure.
3.2.14 Co-ordinator: Person or body which co-ordinates all the
activities associated with a proficiency testing program.
3.2.15 Certified Reference Material (CRM): Reference material (RM),
accompanied by a certificate, one or more of whose property values are
certified by a procedure which establishes its traceability to an accurate
realization of the unit in which the
property values are expressed , and for which each certified value is
accompanied by an uncertainty at a stated level of confidence.
3.2.16 Combined Standard uncertainty (uc): Standard
uncertainty of the result of a measurement when that result is obtained from
the values of a number of other quantities, equal to the positive square root
of a sum of terms, the terms being the variances or covariance’s of these other
quantities weighted according to how the measurement result varies with changes
in these quantities.
3.2.17 Conventional true value (of a quantity): A value of a
quantity which for a given purpose may be substitutes for the true value.
3.2.18 Correction: Value added algebraically to the uncorrected
result of a measurement to compensate for systematic error.
3.2.19 Correction factor: Numerical factor by which the uncorrected
result of a measurement is multiplied to compensate for a systematic error.
3.2.20 Correlation: The relation between two or several random
variables within a distribution of two or more random variables.
3.2.21 Correlation coefficient: The ratio of the covariance of two
random variables to the product of their standard deviations.
3.2.22 Coverage Factor {k}: Number factor used as a multiplier of
the combined standard uncertainty in order to obtain an expanded uncertainty.
3.2.23 Degrees of freedom
(v): The number of terms in a sum minus the number
3.2.24 Extreme results:
Outliers and other values which are grossly inconsistent with other members of
the data set.
3.2.25 Inter laboratory
comparison: Organisation, performance and evaluation of testing /calibration
(competence) on the same or similar items by two or more laboratories in
accordance with pre- determined conditions.
3.2.26 Laboratory accreditation: A formal recognition that a
testing/calibration laboratory is competent to carry out specific test or
specific types of tests or measurements.
3.2.27 Laboratory
assessment: Examination of a testing /calibration to evaluate its
compliance with specific laboratory accreditation criteria.
3.2.28 Laboratory
Co-ordinator: The individual who will be responsible to organize the
proficiency testing program from the approved nodal laboratory /organization.
3.2.29 Management System: The organizational structure,
responsibilities procedures, process and resources needed to implement quality
management.
3.2.30 Management Review: A formal evaluation by top management of
the status and adequacy of quality system in relation to quality policy and
objectives.
3.2.31 Nodal laboratory /body : The approved laboratory
/organization by NABL which may be responsible for organizing specific type of
proficiency testing programs on testing calibration.
3.2.32 Non-Conformity: The non-fulfillment of specified
requirement.
3.2.33 Outlier: Member of a set values which is inconsistent with
the other members of that set.
3.2.34 Observation: A
statement of fact made during an audit and substantiated by objective evidence.
3.2.35 Objective Evidence: Qualitative or quantitative information,
records or statement of fact pertaining to the quality of an item or service or
to the existence and implementation of a quality system element, which is based
on observation, measurement or test and which can be verified.
3.2.36 Proficiency Testing: Methods of checking laboratory
testing/calibration performance by means of inter laboratory comparison.
3.2.37 Precision: The closeness of agreement between independent
test /calibration results obtained under prescribed conditions
3.2.38 Quality Management: That aspect of the overall management
function that determines and implements the quality policy.
3.2.39 Quality Assurance: All those planned and systematic actions
necessary to provide adequate confidence that a product or service will satisfy
given requirements of quality.
3.2.40 Quality Audit: A systematic and independent examination to
determine whether quality activities and related results comply with planned
arrangements and whether these arrangements are implemented effectively and are
suitable to achieve objectives.
3.2.41 Quality Manager: A member of staff with defined responsibility
and authority for ensuring that the
management system is implemented and followed at all times and shall
have direct access to the highest level of management at which decisions are
made on laboratory policy or resources [ISO /IEC 17025, clause 4.1.5 (i)]
3.2.42 Quality Auditor: A person qualified to perform quality
audits.
3.2.43 Reference material (RM):
A material or substance one or more properties of which are sufficiently well
established to be used for the calibration of on apparatus, the assessment of
the measurement method, or for assigning the values to materials.
3.2.44 Reference Laboratory: Laboratory that provides reference
values on a test item with a known uncertainty (usually a National Calibration
Laboratory).
3.2.45 Robust statistical techniques: Techniques to minimize the
influence that extreme results can have on estimates of the mean and standard
deviation.
3.2.46 Test Method: Specified technical procedure for performing a
test.
3.2.47 Test Result: The value of a characteristic, obtained by completely
carrying out a specified measurement method.
3.2.48 Test item: Material or artificial presented to the
participating laboratory for the purpose of proficiency testing.
3.2.49 Testing /calibration Laboratory: A party seeking or holding
NABL accreditation for testing and calibration. This party may be an
individual, an organization or a part of an organization.
3.2.50 Test: Technical operation that consists of the determination
of one or more characteristics of a given product, process or services
according to specified procedure.
3.2.51 Trueness: The closeness of agreement between the average values
obtained from large series of test/calibration results and an accepted
reference value.
3.2.52 Traceability: Property of the result of a measurement or the
value of a standard whereby it can be related to stated references, usually
national or international standards, through an unbroken chain of comparisons
all having stated uncertainties.
3.2.53 Uncertainty of measurement: Parameter associated with the
results of a measurement that characterizes the dispersion of the values that could
reasonably be attributed to the measurement.
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