SlideShare une entreprise Scribd logo
1  sur  83
Laboratory Quality
Management System
Dr Deljo Davis
PMC JJM J&K
Organization Personnel Equipment
Purchasing
and inventory
Process
control
Information
management
Documents
and records
Occurrence
management
Assessment
Process
improvement
Customer
service
Facilities and
safety
•Laboratory quality can be defined as accuracy,
reliability and timeliness of reported test results
•Complexity of Lab
•the laboratory environment
•quality control procedures
•communications
•record keeping
•competent and knowledgeable staff
•good-quality reagents and equipment.
•Volume I - Manual of Quality Policies (ISO
17025 )Requirements
•Volume IIA - Management System Policies and
Procedures
•Volume II B- Technical Policies and Procedures
•Volume III - Laboratory Operations, Applications
and Programs
•Volume IV - Laboratory Training
Volume I - Manual of Quality Policies (ISO
17025 )Requirements
Scope
Normative references
Terms and definitions
General requirements
Impartiality
Confidentiality
5. Structural requirements
6. Resource requirements
6.1 General
6.2 Personnel
6.3 Facilities and environmental condition
6.4 Equipment
6.5 Metrological traceability
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.8.1 General
7.8.2 Common requirements for test reports
7.8.3 Specific requirements for test reports
7.8.4 Specific requirements for calibration certificates
7.8.5 Reporting sampling-specific requirements
7.8.6 Reporting statements of conformity
7.8.7 Reporting opinions and interpretations
7.8.8 Amendments to reports
7.9 Complaints
7.10 Nonconforming work
7. Process requirements
7.1 Review of requests, tenders
and contracts
7.2 Selection, verification and
validation of methods
7.2.1 Selection and verification of
methods
7.2.2 Validation of methods
7.3 Sampling
7.4 Handling of test items
7.5 Technical records
Cont..
8. Management system requirements
8.1 Options
8.1.1 General
8.1.2 Option A
8.1.3 Option B
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option
A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective actions (Option A)
ANNEXURES
I Organization chart
II Laboratory structure
III Layout of Laboratory
IV Scope of Testing for Accreditation
V Level of Documentation
VI List of Management System
Procedure
VII List of Forms and Formats
VIII Quality Objectives
IX Quality Policy
SOP #IIA- 1:- Procedure for review of tenders,
reviews & contracts
• PURPOSE:
• SCOPE:
• DEFINITIONS AND ACRONYMS
• RESPONSIBILITY
• PROCEDURE:
Standard Operating Procedures: management
system and procedure
1 SOP IIA- 1-
Procedure for
Review of Request
2 SOP IIA- 2-
Procedure for
Handling of
Complaints
3 SOP IIA- 3-
Procedure for
Nonconforming
work
4 SOP IIA- 4-
Procedure for
Document Control
5 SOP IIA- 5-
Procedure for
Control of Records
6 SOP IIA- 6-
Procedure for
Management
Review
7 SOP IIA- 7-
Procedure for
Confidentiality
8 SOP IIA- 8-
Procedure for
Independence,
Integrity and
Impartiality
9 SOP IIA- 9-
Procedure for
Internal Audit
10 SOP IIA-
10- Procedure for
Corrective action
Volume IIB - Technical Policies and Procedures
1 SOP IIB- 1-
PROCEDURE FOR
PERSONNEL &
TRAINING -
2 SOP IIB- 2-
PROCEDURE FOR
EQUIPMENT
3 SOP IIB- 3-
PROCEDURE FOR
INTERMEDIATE
CHECKS
4 SOP IIB- 4-
PROCEDURE FOR
HANDLING OF
EQUIPMENT & TEST
ITEMS
5 SOP IIB- 5-
PROCEDURE FOR
ENSURING THE
VALIDITY OF RESULTS
6 SOP IIB- 6-
PROCEDURE FOR
ACCOMMODATION
AND
ENVIRONMENTAL
CONDITIONS
7 SOP IIB- 7-
PROCEDURE FOR
REPORTING OF TEST
RESULTS
8 SOP IIB- 8-
PROCEDURE FOR
UNCERTAINTY OF
MEASUREMENT
Volume III - Laboratory Operations,
Applications and Programs
1 SOP III-
1- Procedure for
Externally
Provided
Services
2 SOP III-
2- Procedure for
Risk &
Opportunity
3 SOP III-
3- Procedure for
Corrective
action
4 SOP III-
4- Procedure for
Use of NABL
Logo
Volume IV - Laboratory Forms and Formats
Volume IV - Laboratory Training
• Section 1 Laboratory Orientation
• Section II Hydro chemistry – IS3025
01-QF-4.1.4 & 4.1.5-Impartiality Risk Assessment
1
Laboratory Management forms close relationship with a client and influences laboratory personnel to
sway Testing results and/or interpretations favorable to the customer.
2
Laboratory Personnel forms close relationship with a client and influences Testing activities to sway
Testing results and/or interpretations favorable to the client.
3
Laboratory is part of a larger organization and incentives from the larger organization influence the
laboratory personnel to sway Testing results favorable to the larger organization.
4
Laboratory personnel are stressed by workload and hide mistakes to avoid rework.
5
Laboratory personnel are not adequately trained to be objective and impartial in their activities.
6
Instructions provided to laboratory personnel are ambiguous and rely on the personal judgement of the
individual performing the activity.
7
Laboratory personnel are affiliated with organizations affected by the outcome of the Testing s and sway
results in favor of that organization.
8
Laboratory personnel are frustrated with the laboratory operation and retaliate against the lab by
reporting erroneous results.
9
Laboratory personnel are offered gifts by the client upon completing the Testing activities.
10
Laboratory personnel or management dislike or disagree with the client on social or political issues and
sway Testing results unfavorably to the client.
11
Laboratory management underestimated the expenses or resources required to complete the work and
influences laboratory personnel to take shortcut to save expenses.
12
Laboratory management underestimated the time required to complete the work and influences
laboratory personnel to take shortcut to save time.
13
Testing items are damaged prior to Testing due to mishandling. The item proceeds to Testing and the
results are reported without regard to the damage prior to Testing .
14
Testing items are damaged during Testing due to machine malfunctions and/or improper execution of
the method. The Testing results are reported without considering the errors.
15
The laboratory uses temporary personnel to perform tests who are not adequately supervised to ensure
impartial execution of the activities and recording of results.
02 -
CONFIDENTIALITY
AGREEMENT
03-QF-5.1-List of Applicable Legal Register
Applicable Legal/
Statutory
Requirements or
License Name
Responsible
Employee for
maintenance of
license
Issuing Governing
Body
Renewal
Frequency
Last Renewal Renewal Due
Date.
04-QF-5.3(a)-Scope of Accreditation- Chemical
pH Colour Taste Odour TDS
Turbudity Calcium Maganisum
Total
hardnes
Chloride
Total
alkalinity
Flouride Iron Nitrate Sulphate
05- QF-5.5(a)-
Laboratory
structure
Chief Chemist/
Corporate Quality
Manager
Assistant
Engineer/ Quality
Manager
Junior Engineer/
Deputy
QualityManager
Chemist/
Technical
Manager
Lab Attendant
Laboratory
Assistant/
Deputy Technical
Manager
Sample Collector
06-QF-5.5(a-
1)-
Organization
structure
Superintending
Engineer
Executive Engineer
Chief Chemist/
Corporate Quality
Manager
Assistant
Engineer/ Quality
Manager
Junior Engineer/
Deputy Quality
Manager
Chemist/
Technical Manager
Lab Attendant
Laboratory
Assistant/ Deputy
Technical Manager
Sample Collector
07- QF-6-2-1-List of employees
Sr No Name Designation Education
Qualification
Experience
08 QF-6-2-5(c)-Training need identification
TRAINING NEED IDENTIFICATION
Specific
area
Elaborate the
requirement
Targeted
Group
Urgency Scale*
Trainer Deadline
4 3 2 1
09- QF-6-2-5(c-1)-Training Calendar
Sr
No
Training
Topic
Planned
Date of
Training
Type of Training
External/Internal
Trainer Trainee(s)/
Targeted group
Actual
Date of
Training
10- QF-6-2-5(c-2)-Training attendance form
11- QF-6-2-
5(c-3)-Training
feedback form
12- QF-6-2-5(c-
4)-Training
evaluation form
13- QF-5.5(b)-
CURRICULUM VITE AND
JOB DESCRIPTION
• And job description
14- QF-6-2-5(a)-Competence Evaluation Form
15- QF-6-2-6-Lab Authorization
Sr
No
Name of
Person
Qualification Experience Training Authorization
for
Authorization
date
Authorized
Signatory
16- QF-6-3-2-Daily temperature monitoring record
17- QF-6-3-4(b)-Housekeeping record
Date Time Cleaning time Disinfectant
used
Cleaning
done by
Checked
by
Remark
Floor Table Office Washroom
18- QF-6-4-13(a & b)-List of Equipment
Sr.
No.
Description Make Model
no./
Serial
No.
Range Accuracy/
Resolution
Lab
ID.
no.
Cal.
Date
Cal.
Due
date
Location
19- QF-6-4-13(e)-Calibration calendar
Sr.
No
Name of
Instruments
Instrument Lab
No.
Calibration
Frequency
Mode of
Calibration
(Internal/
External)
Calibration Program for the Year______
Feb
’21
Mar
’21
Apr
’21
May
’21
Jun
’21
Jul
’21
Aug
’21
Sep
’21
Oct
’21
Nov
’21
Dec
‘21
Jan
‘22
20- QF-6-4-13(e-1)-Calibration status of
equipment
Sr.
No.
Name of
Equipment
Model /
Type
year of
make
Date of
Receipt
/
Date
Placed
in
services
Range
And
Required
Accuracy
Date of
Last
Calibration
Calibration
Due Date
Frequency
of
Calibration
Calibration
agency
Status of
Accuracy
Fit for
Use
Remarks
21- QF-6-4-13(f)-List of reference material
Sr. No.
Name of reference
material / strain /
culture
Source
Date of expiry /
Calibration Validity*
Traceability**
22- QF-6-4-13(g)-Equipment Maintenance Plan
Sr.
No
Name of
Instrumen
t
Instrume
nt ID
Maintenan
ce
Frequency
Mode of
Maintenan
ce
Maintenance Program for the Year: _________(1 year Plan)
Feb
‘21
Mar
‘21
Apr
‘21
May
‘21
June
‘21
July
‘21
Aug
‘21
Sept
‘21
Oct
‘21
Nov
‘21
Dec
‘21
Jan
‘22
15 days Internal √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √
√
√ √ √
1 month Internal √ √ √ √ √ √ √ √ √ √ √ √
23-QF-6-4-13(g-1)-Equipment Maintenance Record
Name of Equipment:
Lab I.D.: Maintenance Frequency (if any) 15 days
Make: Model:
Special Instructions: Reference Standards:
Date Type of Maintenance Date of completion Performed by Remark
24-QF-6-4-13(h)-Equipment History Card
Equipment Name: Location / Area
Equipment No.:
Model / Make:
Sr. No. Date Break down Details Nature of Breakdown Repaired Details Breakdown Time Spare / Parts consumed
25- QF-6-6-List of subcontracting register
SR.
NO.
NAME AND
ADDRESS
ACTIVITY
SUBCONTRACTED
SPECIFICATIONS
(IF ANY)
DATE OF
APPROVAL
DUE DATE
OF
APPROVAL
REMARK
26- QF-6-6-2(a)-External
Product and Service list
District Water Testing Laboratory-
Document Name: External Products and Services List
Document No.: PHEC/WQC/LBM/QF-6.6.2(a)
Issue Date: 2/22/2021
Issue No: 01
Rev. No.: 00
Rev. Date: -
Prepared By: Technical Manager
Reviewed & Issued By Quality Manager
Approved By: Corporate Quality Manager
27- QF-6-6-2-b
Suppliers
Registration
Form
28- QF-6-6-1-List of Approved suppliers
Sr No Supplier Name Contact Person Contact Details Scope of Supply Date of purchase indent
29- QF-6-6-2-b- suppliers Evaluation form
Supplier Evaluation Form
Supplier Name Supplier ID
Business Title Date
Review period Manger
Evaluation
Job Knowledge 1 - poor 2- fair 3satisfactory 4 - Good 5- Excellent
comments
work Quality
comments
imitative
comments
communication
comments
Dependability
comments
overall rating
Evaluation Report
Final Comment
Supplier's Goal
Revivers Signature
30- QF-6-6-2(c)-Incoming Inspection report
Sr.
No.
Date P.O
Number
& Date
Materials/
Items
Accepted /
Rejected
Checked
By
Approved
By
Remarks
31-QF-6-6-2(c-1)-List of Critical consumables
Sr.
No.
Name of critical
consumables
Make Parameter Specifications Observed
Results
Remark Done
by
32- QF-7-4-2-Sample receive register
Sr
No
Date of
Receipt
Customer
Name
Test
Items
Detail
Lab
ID
No
Type of
test
Testing
Parameters
Test Items
Received by
Date of test
Completion
Test
Report
No.
33- QF-7-1-1(a)-Test requisition form
Test Item Name: Lab ID No.
Date of Receipt: Quantity:
Sample Details:
Will be Performed by:
Sample Approved? Yes/ No
Reason for if not approved:
Test Request Communication by: By courier with Letter Head, Verbal, Telephone or by mail
Start Date: Completion Date:
Sr. No. Type of test Parameters
34- QF-7-1-8-
Review of
requests, tenders
& contracts
35- QF-6-2-2-Test Methods
Specific tests / parameters
performed
* Test Method / Standard / Technique against which tests are performed/ Check Availability of latest
version of standard copy
Range of Testing / Limits of
detection
Turbidity IS 3025 (Part 10) 1NTU
pH IS 3025 (Part 11) 6.5- 8.5
Total Hardness IS 3025 (Part 21) 200 mg/l
Total dissolved solids IS 3025 (Part 16) 500 mg/l
Iron IS 3025 (Part 53) 0.3 mg/l
Chloride IS 3025 (Part 32) 250 mg/l
Fluoride IS 3025 (Part 60) 1 mg/l
Nitrate IS 3025 (Part 34) 45 mg/l
Total alkalinity IS 3025 (Part 23) 200 mg/l
Total Arsenic IS 3025 (Part 37) 0.01 mg/l
Sulphate IS 3025 (Part 24) 200 mg/l
Calcium IS 3025 (Part 40) 75.0mg/L
Magnesium IS 3025 (Part 46) 30.0mg/L
Phosphate
Residual free chlorine IS 3025 (Part 26) 0.2
Aluminum IS 3025 (Part 55) 0.03
Copper IS 3025 (Part 42) 0.05
Manganese IS 3025 (Part 59) 0.1
36- QF-7-4-4-Sample retention and disposal register
Sr.
No
Date Time Sample
Description
Sample ID Storage-
Environmental
Condition
Retention
Period
Disposal
Date
Disposed
by
Remark
37. QF-7-5-1-
Raw data
register
38-QF-7-6-Measurement of Uncertainty
Cont..
39- QF-7-7-1-IQC Plan (Individualized Quality Control)
40- QF-7-7-1(e)-Intermediate Check of Instrument
41- QF-7-7-1(f)-Replicate testing
42- QF-7-7-
1(g)-
Retesting of
retained
sample
43- QF-7-7-1(j)-ILC
Plan
44 - QF-7-7-
2(a)-PT Plan
45 – QF
7.8-Test
Report
46 - QF-7-9
(a)-Customer
complaint
Register
47 - QF-7-10-
Non-
conforming
testing
report
Sr.
No.
Date Report
No./
Sample
No.
NC
details
Corrective
action
Root
cause
Changes
made in
samples/
report no.
48 - QF-8-2-
1-Quality
Objectives &
Tracking
INTERESTED PARTIES
SR.
NO.
INTERESTED
PARTY
INTERNAL
OR
EXTERNAL
REASON FOR INTEREST
(REQUIREMENTS/NEEDS/EXPECTATI
ONS)
Impact on
the
organizati
on
Approving
authority
Review
Frequency
Reviewed By
49 -QF-8-2-Context of Organization
Category
Context /
Process /
Interested
Party
Issues
Type of
Issue
(Internal or
External)
Bias
(Positive /
Negative)
Potential
Effect
Review
Frequency
Reviewed
By
12
7
0
10
20
Positive Negative
RESULT
50 - QF-8-3-1-List of External documents
Sr
No
Doc
Name
Doc
No
Ref
Amend
No &
Year
Issue
Date
File
No
Received
by
51 - QF-8-3-2
(a)-Issue and
Approve
control
52 - QF-8-4-2-Master List of Documents
Sr.
No
Docum
ent No
Docum
ent
Title
Docum
ent
Type
Issu
e
No
Issue
Date
Revisi
on
Date
Revisi
on No
Owner
/
Custodi
an
Retenti
on
Period
Storag
e
Locatio
n
Disposa
l
Method
Disposal
Authority
Obsole
te
Copy
Locatio
n
1 QM-
Lab-
ASR-01
Quality
Manual
Manual 1 #####
###
- 0 Quality
Manag
er
3 Years Directo
rs
Cabin/
Cupbo
ard No.
1
Shreddi
ng
ISO
Representa
tive
Cupbo
ard
no.2
53 - QF-8-3-
2(c)-
Document
change
control
54 - QF-8-4-Records matrix
Sr
No
Record
No
Record
Title
Retention
Period
Disposal
Authority
Method of
Disposal
Storage
Location
55 - QF-8-5-Risks & Opportunity register
XXXXX DISTRICT WATER TESTING LABORATORY - JAMMU
RISK & OPPORTUNITY ASSESSMENT
Sr.
No.
Process /
Dept.
Risk
Description
Risk
Severity
(S)
Risk
Probability
(P)
Risk Index
(S X P = I)
Risk
Assessment
Low (1-8),
Medium (9-16),
High (17-25)
Mitigation
Action
Mitigation
Action
Type
Opportunities Proposed
Review
Period
1 Personnel Lack of
supervision
or poor
supervision
3 2 6 Low Already all
available
person's are
comptent
3 All the staff
would be made
competent
enough to
handle lab
activities
themselves
without
supervision
Yearly
56 - QF-8-6-
2-Customer
feedback
form
57 - QF-8-7-
Corrective
action form
58 - QF-8-8-2(a)-Internal Audit schedule
ACTIVITY TO BE
AUDITED FEB’21
MAR
’21
APR
’21
MAY
’21
JUN
’21
JUL
’21
AUG
’21
SEPT
’21
OCT
’21
NOV
’21
DEC
’21
JAN
’22
General Requirements
Structural
Requirements
Resource
Requirements
Process Requirements
Management System
Requirements
59 -QF-8-8-2(b)-Internal Audit plan
Sr.
No.
Date Time Dept Auditee Auditor
60 - QF-8-8-2(b-1)-Internal Audit checklist
Clause Requirement
Observations /
Findings / Evidence
C/NC/PC
4 General requirements
4.1 Impartiality
61 - QF-
8-8-2(d)-
Internal
Audit N.C
report
62 - QF-8-8-2(e)-Internal audit report
63 - QF-8-8-2(e-1)-Internal audit
Summary
64 - QF-8-9-
2-MRM
Agenda
65 - QF-8-9-Attendance for MRM
66- QF-8-9-3-
MRM Action
plan
thanks

Contenu connexe

Tendances

Total Quality Management (TQM) by Dr Anurag Yadav
Total Quality Management (TQM) by Dr Anurag YadavTotal Quality Management (TQM) by Dr Anurag Yadav
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
 
Six Sigma in clinical laboratory
Six Sigma in clinical laboratorySix Sigma in clinical laboratory
Six Sigma in clinical laboratoryAhmed Al-Abadlah
 
Quality control lecture CPath master 2014 Ain Shams
Quality control lecture CPath master 2014 Ain ShamsQuality control lecture CPath master 2014 Ain Shams
Quality control lecture CPath master 2014 Ain ShamsAdel Elazab Elged
 
Internal quality control
Internal quality controlInternal quality control
Internal quality controlSyed Basheer
 
Pre analytic and postanalytic test management
Pre analytic and postanalytic test managementPre analytic and postanalytic test management
Pre analytic and postanalytic test managementVarsha Shahane
 
Designing an appropriate QC procedure for your laboratory
Designing an appropriate QC procedure for your laboratoryDesigning an appropriate QC procedure for your laboratory
Designing an appropriate QC procedure for your laboratoryRandox
 
Quality Control in Pathological Laboratory
Quality Control in Pathological LaboratoryQuality Control in Pathological Laboratory
Quality Control in Pathological Laboratorysanarehman8159
 
Quality Assurance Qual Indicators.ppt
Quality Assurance Qual Indicators.pptQuality Assurance Qual Indicators.ppt
Quality Assurance Qual Indicators.pptSUNILDhatwalia1
 
Dr. negi quality assurance
Dr. negi quality assuranceDr. negi quality assurance
Dr. negi quality assurancesanjay negi
 
Laboratory Internal Quality Control presentation master revision, 2014
Laboratory Internal Quality Control presentation master revision, 2014Laboratory Internal Quality Control presentation master revision, 2014
Laboratory Internal Quality Control presentation master revision, 2014Adel Elazab Elged
 
Laboratory accreditation
Laboratory accreditationLaboratory accreditation
Laboratory accreditationGift Sam
 
Quality assurance in medical laboratory
Quality assurance in medical laboratoryQuality assurance in medical laboratory
Quality assurance in medical laboratoryFaiz Alkhawlani
 
Harmonization of Laboratory Indicators, 09 03-2017
Harmonization of Laboratory Indicators, 09 03-2017Harmonization of Laboratory Indicators, 09 03-2017
Harmonization of Laboratory Indicators, 09 03-2017Ola Elgaddar
 
Presentation on ISO 15189 documentation
Presentation on ISO 15189 documentationPresentation on ISO 15189 documentation
Presentation on ISO 15189 documentationGlobal Manager Group
 
Troubleshooting QC Problems: Your QC has failed, what do you do next?
Troubleshooting QC Problems: Your QC has failed, what do you do next?Troubleshooting QC Problems: Your QC has failed, what do you do next?
Troubleshooting QC Problems: Your QC has failed, what do you do next?Randox
 
Risk based methodology in Laboratory Management System
Risk based methodology in Laboratory Management SystemRisk based methodology in Laboratory Management System
Risk based methodology in Laboratory Management SystemPECB
 
Total Quality Management for Medical Labs - Ravi Kumudesh
Total Quality Management for Medical Labs - Ravi KumudeshTotal Quality Management for Medical Labs - Ravi Kumudesh
Total Quality Management for Medical Labs - Ravi KumudeshRavi Kumudesh
 

Tendances (20)

Total Quality Management (TQM) by Dr Anurag Yadav
Total Quality Management (TQM) by Dr Anurag YadavTotal Quality Management (TQM) by Dr Anurag Yadav
Total Quality Management (TQM) by Dr Anurag Yadav
 
Six Sigma in clinical laboratory
Six Sigma in clinical laboratorySix Sigma in clinical laboratory
Six Sigma in clinical laboratory
 
Quality control lecture CPath master 2014 Ain Shams
Quality control lecture CPath master 2014 Ain ShamsQuality control lecture CPath master 2014 Ain Shams
Quality control lecture CPath master 2014 Ain Shams
 
Internal quality control
Internal quality controlInternal quality control
Internal quality control
 
Pre analytic and postanalytic test management
Pre analytic and postanalytic test managementPre analytic and postanalytic test management
Pre analytic and postanalytic test management
 
quality control in pathology
quality control in pathologyquality control in pathology
quality control in pathology
 
Laboratory accreditation by iso 15189
Laboratory accreditation by iso 15189Laboratory accreditation by iso 15189
Laboratory accreditation by iso 15189
 
Designing an appropriate QC procedure for your laboratory
Designing an appropriate QC procedure for your laboratoryDesigning an appropriate QC procedure for your laboratory
Designing an appropriate QC procedure for your laboratory
 
Quality Control in Pathological Laboratory
Quality Control in Pathological LaboratoryQuality Control in Pathological Laboratory
Quality Control in Pathological Laboratory
 
Quality Assurance Qual Indicators.ppt
Quality Assurance Qual Indicators.pptQuality Assurance Qual Indicators.ppt
Quality Assurance Qual Indicators.ppt
 
Dr. negi quality assurance
Dr. negi quality assuranceDr. negi quality assurance
Dr. negi quality assurance
 
Laboratory Internal Quality Control presentation master revision, 2014
Laboratory Internal Quality Control presentation master revision, 2014Laboratory Internal Quality Control presentation master revision, 2014
Laboratory Internal Quality Control presentation master revision, 2014
 
Laboratory accreditation
Laboratory accreditationLaboratory accreditation
Laboratory accreditation
 
Quality control
Quality controlQuality control
Quality control
 
Quality assurance in medical laboratory
Quality assurance in medical laboratoryQuality assurance in medical laboratory
Quality assurance in medical laboratory
 
Harmonization of Laboratory Indicators, 09 03-2017
Harmonization of Laboratory Indicators, 09 03-2017Harmonization of Laboratory Indicators, 09 03-2017
Harmonization of Laboratory Indicators, 09 03-2017
 
Presentation on ISO 15189 documentation
Presentation on ISO 15189 documentationPresentation on ISO 15189 documentation
Presentation on ISO 15189 documentation
 
Troubleshooting QC Problems: Your QC has failed, what do you do next?
Troubleshooting QC Problems: Your QC has failed, what do you do next?Troubleshooting QC Problems: Your QC has failed, what do you do next?
Troubleshooting QC Problems: Your QC has failed, what do you do next?
 
Risk based methodology in Laboratory Management System
Risk based methodology in Laboratory Management SystemRisk based methodology in Laboratory Management System
Risk based methodology in Laboratory Management System
 
Total Quality Management for Medical Labs - Ravi Kumudesh
Total Quality Management for Medical Labs - Ravi KumudeshTotal Quality Management for Medical Labs - Ravi Kumudesh
Total Quality Management for Medical Labs - Ravi Kumudesh
 

Similaire à Laboratory quality management system

ISO 17025 Accreditation Detail Review
ISO 17025 Accreditation Detail Review ISO 17025 Accreditation Detail Review
ISO 17025 Accreditation Detail Review Abdul Rahman
 
Nabl guidlines part 1
Nabl guidlines part 1Nabl guidlines part 1
Nabl guidlines part 1sukanya patel
 
Nabl guidlines part 2
Nabl guidlines part 2Nabl guidlines part 2
Nabl guidlines part 2sukanya patel
 
General requirements for the competence of testing and calibration laboratories
General requirements for the competence of testing and calibration laboratories General requirements for the competence of testing and calibration laboratories
General requirements for the competence of testing and calibration laboratories Hadi Akbar
 
Introduction to Quality Management System .pdf
Introduction to Quality Management System .pdfIntroduction to Quality Management System .pdf
Introduction to Quality Management System .pdfBALASUNDARESAN M
 
ISO 17025
ISO 17025 ISO 17025
ISO 17025 Akma Ija
 
Good clinical laboratory practices
Good clinical laboratory practicesGood clinical laboratory practices
Good clinical laboratory practicesVamsi kumar
 
Quality management systems: Good Laboratory Practice (QMS GLP)
Quality management systems: Good Laboratory Practice (QMS GLP)Quality management systems: Good Laboratory Practice (QMS GLP)
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
 
ISO 15189 Awareness.pptx
ISO 15189 Awareness.pptxISO 15189 Awareness.pptx
ISO 15189 Awareness.pptxNorAhmad24
 
Good laboratory practices in a pharmaceutical lab 1
Good laboratory practices in a pharmaceutical lab 1Good laboratory practices in a pharmaceutical lab 1
Good laboratory practices in a pharmaceutical lab 1Sabahat Ali
 
Quality assurance in blood banking
Quality assurance in blood bankingQuality assurance in blood banking
Quality assurance in blood bankingDr Shahida Baloch
 
ISO/IEC 17025
ISO/IEC 17025 ISO/IEC 17025
ISO/IEC 17025 Akma Ija
 

Similaire à Laboratory quality management system (20)

ISO 17025 Accreditation Detail Review
ISO 17025 Accreditation Detail Review ISO 17025 Accreditation Detail Review
ISO 17025 Accreditation Detail Review
 
Nabl guidlines part 1
Nabl guidlines part 1Nabl guidlines part 1
Nabl guidlines part 1
 
Nabl guidlines part 2
Nabl guidlines part 2Nabl guidlines part 2
Nabl guidlines part 2
 
Item 13
Item 13Item 13
Item 13
 
General requirements for the competence of testing and calibration laboratories
General requirements for the competence of testing and calibration laboratories General requirements for the competence of testing and calibration laboratories
General requirements for the competence of testing and calibration laboratories
 
Introduction to Quality Management System .pdf
Introduction to Quality Management System .pdfIntroduction to Quality Management System .pdf
Introduction to Quality Management System .pdf
 
IP 2 Unit 4 NABL, OOS, GLP.pdf
IP 2 Unit 4 NABL, OOS, GLP.pdfIP 2 Unit 4 NABL, OOS, GLP.pdf
IP 2 Unit 4 NABL, OOS, GLP.pdf
 
The ISO 17025 standard: principles and management requirements
The ISO 17025 standard: principles and management requirementsThe ISO 17025 standard: principles and management requirements
The ISO 17025 standard: principles and management requirements
 
Face.ppt
Face.pptFace.ppt
Face.ppt
 
ISO 17025
ISO 17025 ISO 17025
ISO 17025
 
Good clinical laboratory practices
Good clinical laboratory practicesGood clinical laboratory practices
Good clinical laboratory practices
 
Quality tip 18
Quality tip 18Quality tip 18
Quality tip 18
 
Practical auditing
Practical auditingPractical auditing
Practical auditing
 
Iso 15189 white paper
Iso   15189 white paperIso   15189 white paper
Iso 15189 white paper
 
GLP FINAL.pptx
GLP FINAL.pptxGLP FINAL.pptx
GLP FINAL.pptx
 
Quality management systems: Good Laboratory Practice (QMS GLP)
Quality management systems: Good Laboratory Practice (QMS GLP)Quality management systems: Good Laboratory Practice (QMS GLP)
Quality management systems: Good Laboratory Practice (QMS GLP)
 
ISO 15189 Awareness.pptx
ISO 15189 Awareness.pptxISO 15189 Awareness.pptx
ISO 15189 Awareness.pptx
 
Good laboratory practices in a pharmaceutical lab 1
Good laboratory practices in a pharmaceutical lab 1Good laboratory practices in a pharmaceutical lab 1
Good laboratory practices in a pharmaceutical lab 1
 
Quality assurance in blood banking
Quality assurance in blood bankingQuality assurance in blood banking
Quality assurance in blood banking
 
ISO/IEC 17025
ISO/IEC 17025 ISO/IEC 17025
ISO/IEC 17025
 

Dernier

Joka \ Call Girls Service Kolkata - 450+ Call Girl Cash Payment 8005736733 Ne...
Joka \ Call Girls Service Kolkata - 450+ Call Girl Cash Payment 8005736733 Ne...Joka \ Call Girls Service Kolkata - 450+ Call Girl Cash Payment 8005736733 Ne...
Joka \ Call Girls Service Kolkata - 450+ Call Girl Cash Payment 8005736733 Ne...HyderabadDolls
 
Mira Road Reasonable Call Girls ,09167354423,Kashimira Call Girls Service
Mira Road Reasonable Call Girls ,09167354423,Kashimira Call Girls ServiceMira Road Reasonable Call Girls ,09167354423,Kashimira Call Girls Service
Mira Road Reasonable Call Girls ,09167354423,Kashimira Call Girls ServicePriya Reddy
 
Yil Me Hu Spring 2024 - Nisqually Salmon Recovery Newsletter
Yil Me Hu Spring 2024 - Nisqually Salmon Recovery NewsletterYil Me Hu Spring 2024 - Nisqually Salmon Recovery Newsletter
Yil Me Hu Spring 2024 - Nisqually Salmon Recovery NewsletterNisqually River Council
 
Russian Escort Dubai 0503464457 Dubai Escorts
Russian Escort Dubai 0503464457 Dubai EscortsRussian Escort Dubai 0503464457 Dubai Escorts
Russian Escort Dubai 0503464457 Dubai EscortsMonica Sydney
 
Call Girl in Faridabad ₹7.5k Pick Up & Drop With Cash Payment #8168257667
Call Girl in Faridabad ₹7.5k Pick Up & Drop With Cash Payment #8168257667Call Girl in Faridabad ₹7.5k Pick Up & Drop With Cash Payment #8168257667
Call Girl in Faridabad ₹7.5k Pick Up & Drop With Cash Payment #8168257667Hyderabad Escorts Agency
 
Fuel Cells and Hydrogen in Transportation - An Introduction
Fuel Cells and Hydrogen in Transportation - An IntroductionFuel Cells and Hydrogen in Transportation - An Introduction
Fuel Cells and Hydrogen in Transportation - An IntroductionGlenn Rambach
 
Call Girls in Gachibowli / 8250092165 Genuine Call girls with real Photos and...
Call Girls in Gachibowli / 8250092165 Genuine Call girls with real Photos and...Call Girls in Gachibowli / 8250092165 Genuine Call girls with real Photos and...
Call Girls in Gachibowli / 8250092165 Genuine Call girls with real Photos and...kumargunjan9515
 
Book Call Girls in Kathua { 9332606886 } VVIP NISHA Call Girls Near 5 Star Hotel
Book Call Girls in Kathua { 9332606886 } VVIP NISHA Call Girls Near 5 Star HotelBook Call Girls in Kathua { 9332606886 } VVIP NISHA Call Girls Near 5 Star Hotel
Book Call Girls in Kathua { 9332606886 } VVIP NISHA Call Girls Near 5 Star Hotelkumargunjan9515
 
Yil Me Hu Summer 2023 Edition - Nisqually Salmon Recovery Newsletter
Yil Me Hu Summer 2023 Edition - Nisqually Salmon Recovery NewsletterYil Me Hu Summer 2023 Edition - Nisqually Salmon Recovery Newsletter
Yil Me Hu Summer 2023 Edition - Nisqually Salmon Recovery NewsletterNisqually River Council
 
Hook Up Call Girls Rajgir 9332606886 High Profile Call Girls You Can Get T...
Hook Up Call Girls Rajgir   9332606886  High Profile Call Girls You Can Get T...Hook Up Call Girls Rajgir   9332606886  High Profile Call Girls You Can Get T...
Hook Up Call Girls Rajgir 9332606886 High Profile Call Girls You Can Get T...Sareena Khatun
 
Corporate_Science-based_Target_Setting.pptx
Corporate_Science-based_Target_Setting.pptxCorporate_Science-based_Target_Setting.pptx
Corporate_Science-based_Target_Setting.pptxarnab132
 
case-study-marcopper-disaster in the philippines.pdf
case-study-marcopper-disaster in the philippines.pdfcase-study-marcopper-disaster in the philippines.pdf
case-study-marcopper-disaster in the philippines.pdfgarthraymundo123
 
Russian Call girls in Dubai 0508644382 Dubai Call girls
Russian Call girls in Dubai 0508644382 Dubai Call girlsRussian Call girls in Dubai 0508644382 Dubai Call girls
Russian Call girls in Dubai 0508644382 Dubai Call girlsMonica Sydney
 
Test bank for beckmann and ling s obstetrics and gynecology 8th edition by ro...
Test bank for beckmann and ling s obstetrics and gynecology 8th edition by ro...Test bank for beckmann and ling s obstetrics and gynecology 8th edition by ro...
Test bank for beckmann and ling s obstetrics and gynecology 8th edition by ro...robinsonayot
 
High Profile Call Girls Service in Udhampur 9332606886 High Profile Call G...
High Profile Call Girls Service in Udhampur   9332606886  High Profile Call G...High Profile Call Girls Service in Udhampur   9332606886  High Profile Call G...
High Profile Call Girls Service in Udhampur 9332606886 High Profile Call G...kumargunjan9515
 
A Review on Integrated River Basin Management and Development Master Plan of ...
A Review on Integrated River Basin Management and Development Master Plan of ...A Review on Integrated River Basin Management and Development Master Plan of ...
A Review on Integrated River Basin Management and Development Master Plan of ...Mark Jaeno P. Duyan
 
Call Girls in Dattatreya Nagar / 8250092165 Genuine Call girls with real Phot...
Call Girls in Dattatreya Nagar / 8250092165 Genuine Call girls with real Phot...Call Girls in Dattatreya Nagar / 8250092165 Genuine Call girls with real Phot...
Call Girls in Dattatreya Nagar / 8250092165 Genuine Call girls with real Phot...kumargunjan9515
 

Dernier (20)

Joka \ Call Girls Service Kolkata - 450+ Call Girl Cash Payment 8005736733 Ne...
Joka \ Call Girls Service Kolkata - 450+ Call Girl Cash Payment 8005736733 Ne...Joka \ Call Girls Service Kolkata - 450+ Call Girl Cash Payment 8005736733 Ne...
Joka \ Call Girls Service Kolkata - 450+ Call Girl Cash Payment 8005736733 Ne...
 
Mira Road Reasonable Call Girls ,09167354423,Kashimira Call Girls Service
Mira Road Reasonable Call Girls ,09167354423,Kashimira Call Girls ServiceMira Road Reasonable Call Girls ,09167354423,Kashimira Call Girls Service
Mira Road Reasonable Call Girls ,09167354423,Kashimira Call Girls Service
 
Yil Me Hu Spring 2024 - Nisqually Salmon Recovery Newsletter
Yil Me Hu Spring 2024 - Nisqually Salmon Recovery NewsletterYil Me Hu Spring 2024 - Nisqually Salmon Recovery Newsletter
Yil Me Hu Spring 2024 - Nisqually Salmon Recovery Newsletter
 
Russian Escort Dubai 0503464457 Dubai Escorts
Russian Escort Dubai 0503464457 Dubai EscortsRussian Escort Dubai 0503464457 Dubai Escorts
Russian Escort Dubai 0503464457 Dubai Escorts
 
Call Girl in Faridabad ₹7.5k Pick Up & Drop With Cash Payment #8168257667
Call Girl in Faridabad ₹7.5k Pick Up & Drop With Cash Payment #8168257667Call Girl in Faridabad ₹7.5k Pick Up & Drop With Cash Payment #8168257667
Call Girl in Faridabad ₹7.5k Pick Up & Drop With Cash Payment #8168257667
 
Fuel Cells and Hydrogen in Transportation - An Introduction
Fuel Cells and Hydrogen in Transportation - An IntroductionFuel Cells and Hydrogen in Transportation - An Introduction
Fuel Cells and Hydrogen in Transportation - An Introduction
 
Call Girls in Gachibowli / 8250092165 Genuine Call girls with real Photos and...
Call Girls in Gachibowli / 8250092165 Genuine Call girls with real Photos and...Call Girls in Gachibowli / 8250092165 Genuine Call girls with real Photos and...
Call Girls in Gachibowli / 8250092165 Genuine Call girls with real Photos and...
 
Book Call Girls in Kathua { 9332606886 } VVIP NISHA Call Girls Near 5 Star Hotel
Book Call Girls in Kathua { 9332606886 } VVIP NISHA Call Girls Near 5 Star HotelBook Call Girls in Kathua { 9332606886 } VVIP NISHA Call Girls Near 5 Star Hotel
Book Call Girls in Kathua { 9332606886 } VVIP NISHA Call Girls Near 5 Star Hotel
 
Yil Me Hu Summer 2023 Edition - Nisqually Salmon Recovery Newsletter
Yil Me Hu Summer 2023 Edition - Nisqually Salmon Recovery NewsletterYil Me Hu Summer 2023 Edition - Nisqually Salmon Recovery Newsletter
Yil Me Hu Summer 2023 Edition - Nisqually Salmon Recovery Newsletter
 
Jumping Scales and Producing peripheries.pptx
Jumping Scales and Producing peripheries.pptxJumping Scales and Producing peripheries.pptx
Jumping Scales and Producing peripheries.pptx
 
Hook Up Call Girls Rajgir 9332606886 High Profile Call Girls You Can Get T...
Hook Up Call Girls Rajgir   9332606886  High Profile Call Girls You Can Get T...Hook Up Call Girls Rajgir   9332606886  High Profile Call Girls You Can Get T...
Hook Up Call Girls Rajgir 9332606886 High Profile Call Girls You Can Get T...
 
Deforestation
DeforestationDeforestation
Deforestation
 
Corporate_Science-based_Target_Setting.pptx
Corporate_Science-based_Target_Setting.pptxCorporate_Science-based_Target_Setting.pptx
Corporate_Science-based_Target_Setting.pptx
 
Water Pollution
Water Pollution Water Pollution
Water Pollution
 
case-study-marcopper-disaster in the philippines.pdf
case-study-marcopper-disaster in the philippines.pdfcase-study-marcopper-disaster in the philippines.pdf
case-study-marcopper-disaster in the philippines.pdf
 
Russian Call girls in Dubai 0508644382 Dubai Call girls
Russian Call girls in Dubai 0508644382 Dubai Call girlsRussian Call girls in Dubai 0508644382 Dubai Call girls
Russian Call girls in Dubai 0508644382 Dubai Call girls
 
Test bank for beckmann and ling s obstetrics and gynecology 8th edition by ro...
Test bank for beckmann and ling s obstetrics and gynecology 8th edition by ro...Test bank for beckmann and ling s obstetrics and gynecology 8th edition by ro...
Test bank for beckmann and ling s obstetrics and gynecology 8th edition by ro...
 
High Profile Call Girls Service in Udhampur 9332606886 High Profile Call G...
High Profile Call Girls Service in Udhampur   9332606886  High Profile Call G...High Profile Call Girls Service in Udhampur   9332606886  High Profile Call G...
High Profile Call Girls Service in Udhampur 9332606886 High Profile Call G...
 
A Review on Integrated River Basin Management and Development Master Plan of ...
A Review on Integrated River Basin Management and Development Master Plan of ...A Review on Integrated River Basin Management and Development Master Plan of ...
A Review on Integrated River Basin Management and Development Master Plan of ...
 
Call Girls in Dattatreya Nagar / 8250092165 Genuine Call girls with real Phot...
Call Girls in Dattatreya Nagar / 8250092165 Genuine Call girls with real Phot...Call Girls in Dattatreya Nagar / 8250092165 Genuine Call girls with real Phot...
Call Girls in Dattatreya Nagar / 8250092165 Genuine Call girls with real Phot...
 

Laboratory quality management system

  • 1. Laboratory Quality Management System Dr Deljo Davis PMC JJM J&K
  • 2. Organization Personnel Equipment Purchasing and inventory Process control Information management Documents and records Occurrence management Assessment Process improvement Customer service Facilities and safety
  • 3. •Laboratory quality can be defined as accuracy, reliability and timeliness of reported test results •Complexity of Lab •the laboratory environment •quality control procedures •communications •record keeping •competent and knowledgeable staff •good-quality reagents and equipment.
  • 4. •Volume I - Manual of Quality Policies (ISO 17025 )Requirements •Volume IIA - Management System Policies and Procedures •Volume II B- Technical Policies and Procedures •Volume III - Laboratory Operations, Applications and Programs •Volume IV - Laboratory Training
  • 5. Volume I - Manual of Quality Policies (ISO 17025 )Requirements Scope Normative references Terms and definitions General requirements Impartiality Confidentiality
  • 6. 5. Structural requirements 6. Resource requirements 6.1 General 6.2 Personnel 6.3 Facilities and environmental condition 6.4 Equipment 6.5 Metrological traceability
  • 7. 7.6 Evaluation of measurement uncertainty 7.7 Ensuring the validity of results 7.8 Reporting of results 7.8.1 General 7.8.2 Common requirements for test reports 7.8.3 Specific requirements for test reports 7.8.4 Specific requirements for calibration certificates 7.8.5 Reporting sampling-specific requirements 7.8.6 Reporting statements of conformity 7.8.7 Reporting opinions and interpretations 7.8.8 Amendments to reports 7.9 Complaints 7.10 Nonconforming work 7. Process requirements 7.1 Review of requests, tenders and contracts 7.2 Selection, verification and validation of methods 7.2.1 Selection and verification of methods 7.2.2 Validation of methods 7.3 Sampling 7.4 Handling of test items 7.5 Technical records
  • 8. Cont.. 8. Management system requirements 8.1 Options 8.1.1 General 8.1.2 Option A 8.1.3 Option B 8.2 Management system documentation (Option A) 8.3 Control of management system documents (Option A) 8.4 Control of records (Option A) 8.5 Actions to address risks and opportunities (Option A) 8.6 Improvement (Option A) 8.7 Corrective actions (Option A)
  • 9. ANNEXURES I Organization chart II Laboratory structure III Layout of Laboratory IV Scope of Testing for Accreditation V Level of Documentation VI List of Management System Procedure VII List of Forms and Formats VIII Quality Objectives IX Quality Policy
  • 10. SOP #IIA- 1:- Procedure for review of tenders, reviews & contracts • PURPOSE: • SCOPE: • DEFINITIONS AND ACRONYMS • RESPONSIBILITY • PROCEDURE:
  • 11. Standard Operating Procedures: management system and procedure 1 SOP IIA- 1- Procedure for Review of Request 2 SOP IIA- 2- Procedure for Handling of Complaints 3 SOP IIA- 3- Procedure for Nonconforming work 4 SOP IIA- 4- Procedure for Document Control 5 SOP IIA- 5- Procedure for Control of Records 6 SOP IIA- 6- Procedure for Management Review 7 SOP IIA- 7- Procedure for Confidentiality 8 SOP IIA- 8- Procedure for Independence, Integrity and Impartiality 9 SOP IIA- 9- Procedure for Internal Audit 10 SOP IIA- 10- Procedure for Corrective action
  • 12. Volume IIB - Technical Policies and Procedures 1 SOP IIB- 1- PROCEDURE FOR PERSONNEL & TRAINING - 2 SOP IIB- 2- PROCEDURE FOR EQUIPMENT 3 SOP IIB- 3- PROCEDURE FOR INTERMEDIATE CHECKS 4 SOP IIB- 4- PROCEDURE FOR HANDLING OF EQUIPMENT & TEST ITEMS 5 SOP IIB- 5- PROCEDURE FOR ENSURING THE VALIDITY OF RESULTS 6 SOP IIB- 6- PROCEDURE FOR ACCOMMODATION AND ENVIRONMENTAL CONDITIONS 7 SOP IIB- 7- PROCEDURE FOR REPORTING OF TEST RESULTS 8 SOP IIB- 8- PROCEDURE FOR UNCERTAINTY OF MEASUREMENT
  • 13. Volume III - Laboratory Operations, Applications and Programs 1 SOP III- 1- Procedure for Externally Provided Services 2 SOP III- 2- Procedure for Risk & Opportunity 3 SOP III- 3- Procedure for Corrective action 4 SOP III- 4- Procedure for Use of NABL Logo
  • 14. Volume IV - Laboratory Forms and Formats Volume IV - Laboratory Training • Section 1 Laboratory Orientation • Section II Hydro chemistry – IS3025
  • 15. 01-QF-4.1.4 & 4.1.5-Impartiality Risk Assessment 1 Laboratory Management forms close relationship with a client and influences laboratory personnel to sway Testing results and/or interpretations favorable to the customer. 2 Laboratory Personnel forms close relationship with a client and influences Testing activities to sway Testing results and/or interpretations favorable to the client. 3 Laboratory is part of a larger organization and incentives from the larger organization influence the laboratory personnel to sway Testing results favorable to the larger organization. 4 Laboratory personnel are stressed by workload and hide mistakes to avoid rework. 5 Laboratory personnel are not adequately trained to be objective and impartial in their activities. 6 Instructions provided to laboratory personnel are ambiguous and rely on the personal judgement of the individual performing the activity. 7 Laboratory personnel are affiliated with organizations affected by the outcome of the Testing s and sway results in favor of that organization. 8 Laboratory personnel are frustrated with the laboratory operation and retaliate against the lab by reporting erroneous results.
  • 16. 9 Laboratory personnel are offered gifts by the client upon completing the Testing activities. 10 Laboratory personnel or management dislike or disagree with the client on social or political issues and sway Testing results unfavorably to the client. 11 Laboratory management underestimated the expenses or resources required to complete the work and influences laboratory personnel to take shortcut to save expenses. 12 Laboratory management underestimated the time required to complete the work and influences laboratory personnel to take shortcut to save time. 13 Testing items are damaged prior to Testing due to mishandling. The item proceeds to Testing and the results are reported without regard to the damage prior to Testing . 14 Testing items are damaged during Testing due to machine malfunctions and/or improper execution of the method. The Testing results are reported without considering the errors. 15 The laboratory uses temporary personnel to perform tests who are not adequately supervised to ensure impartial execution of the activities and recording of results.
  • 18. 03-QF-5.1-List of Applicable Legal Register Applicable Legal/ Statutory Requirements or License Name Responsible Employee for maintenance of license Issuing Governing Body Renewal Frequency Last Renewal Renewal Due Date.
  • 19. 04-QF-5.3(a)-Scope of Accreditation- Chemical pH Colour Taste Odour TDS Turbudity Calcium Maganisum Total hardnes Chloride Total alkalinity Flouride Iron Nitrate Sulphate
  • 20. 05- QF-5.5(a)- Laboratory structure Chief Chemist/ Corporate Quality Manager Assistant Engineer/ Quality Manager Junior Engineer/ Deputy QualityManager Chemist/ Technical Manager Lab Attendant Laboratory Assistant/ Deputy Technical Manager Sample Collector
  • 21. 06-QF-5.5(a- 1)- Organization structure Superintending Engineer Executive Engineer Chief Chemist/ Corporate Quality Manager Assistant Engineer/ Quality Manager Junior Engineer/ Deputy Quality Manager Chemist/ Technical Manager Lab Attendant Laboratory Assistant/ Deputy Technical Manager Sample Collector
  • 22. 07- QF-6-2-1-List of employees Sr No Name Designation Education Qualification Experience
  • 23. 08 QF-6-2-5(c)-Training need identification TRAINING NEED IDENTIFICATION Specific area Elaborate the requirement Targeted Group Urgency Scale* Trainer Deadline 4 3 2 1
  • 24. 09- QF-6-2-5(c-1)-Training Calendar Sr No Training Topic Planned Date of Training Type of Training External/Internal Trainer Trainee(s)/ Targeted group Actual Date of Training
  • 28. 13- QF-5.5(b)- CURRICULUM VITE AND JOB DESCRIPTION • And job description
  • 30. 15- QF-6-2-6-Lab Authorization Sr No Name of Person Qualification Experience Training Authorization for Authorization date Authorized Signatory
  • 31. 16- QF-6-3-2-Daily temperature monitoring record
  • 32. 17- QF-6-3-4(b)-Housekeeping record Date Time Cleaning time Disinfectant used Cleaning done by Checked by Remark Floor Table Office Washroom
  • 33. 18- QF-6-4-13(a & b)-List of Equipment Sr. No. Description Make Model no./ Serial No. Range Accuracy/ Resolution Lab ID. no. Cal. Date Cal. Due date Location
  • 34. 19- QF-6-4-13(e)-Calibration calendar Sr. No Name of Instruments Instrument Lab No. Calibration Frequency Mode of Calibration (Internal/ External) Calibration Program for the Year______ Feb ’21 Mar ’21 Apr ’21 May ’21 Jun ’21 Jul ’21 Aug ’21 Sep ’21 Oct ’21 Nov ’21 Dec ‘21 Jan ‘22
  • 35. 20- QF-6-4-13(e-1)-Calibration status of equipment Sr. No. Name of Equipment Model / Type year of make Date of Receipt / Date Placed in services Range And Required Accuracy Date of Last Calibration Calibration Due Date Frequency of Calibration Calibration agency Status of Accuracy Fit for Use Remarks
  • 36. 21- QF-6-4-13(f)-List of reference material Sr. No. Name of reference material / strain / culture Source Date of expiry / Calibration Validity* Traceability**
  • 37. 22- QF-6-4-13(g)-Equipment Maintenance Plan Sr. No Name of Instrumen t Instrume nt ID Maintenan ce Frequency Mode of Maintenan ce Maintenance Program for the Year: _________(1 year Plan) Feb ‘21 Mar ‘21 Apr ‘21 May ‘21 June ‘21 July ‘21 Aug ‘21 Sept ‘21 Oct ‘21 Nov ‘21 Dec ‘21 Jan ‘22 15 days Internal √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 1 month Internal √ √ √ √ √ √ √ √ √ √ √ √
  • 38. 23-QF-6-4-13(g-1)-Equipment Maintenance Record Name of Equipment: Lab I.D.: Maintenance Frequency (if any) 15 days Make: Model: Special Instructions: Reference Standards: Date Type of Maintenance Date of completion Performed by Remark
  • 39. 24-QF-6-4-13(h)-Equipment History Card Equipment Name: Location / Area Equipment No.: Model / Make: Sr. No. Date Break down Details Nature of Breakdown Repaired Details Breakdown Time Spare / Parts consumed
  • 40. 25- QF-6-6-List of subcontracting register SR. NO. NAME AND ADDRESS ACTIVITY SUBCONTRACTED SPECIFICATIONS (IF ANY) DATE OF APPROVAL DUE DATE OF APPROVAL REMARK
  • 41. 26- QF-6-6-2(a)-External Product and Service list District Water Testing Laboratory- Document Name: External Products and Services List Document No.: PHEC/WQC/LBM/QF-6.6.2(a) Issue Date: 2/22/2021 Issue No: 01 Rev. No.: 00 Rev. Date: - Prepared By: Technical Manager Reviewed & Issued By Quality Manager Approved By: Corporate Quality Manager
  • 43. 28- QF-6-6-1-List of Approved suppliers Sr No Supplier Name Contact Person Contact Details Scope of Supply Date of purchase indent
  • 44. 29- QF-6-6-2-b- suppliers Evaluation form Supplier Evaluation Form Supplier Name Supplier ID Business Title Date Review period Manger Evaluation Job Knowledge 1 - poor 2- fair 3satisfactory 4 - Good 5- Excellent comments work Quality comments imitative comments communication comments Dependability comments overall rating Evaluation Report Final Comment Supplier's Goal Revivers Signature
  • 45. 30- QF-6-6-2(c)-Incoming Inspection report Sr. No. Date P.O Number & Date Materials/ Items Accepted / Rejected Checked By Approved By Remarks
  • 46. 31-QF-6-6-2(c-1)-List of Critical consumables Sr. No. Name of critical consumables Make Parameter Specifications Observed Results Remark Done by
  • 47. 32- QF-7-4-2-Sample receive register Sr No Date of Receipt Customer Name Test Items Detail Lab ID No Type of test Testing Parameters Test Items Received by Date of test Completion Test Report No.
  • 48. 33- QF-7-1-1(a)-Test requisition form Test Item Name: Lab ID No. Date of Receipt: Quantity: Sample Details: Will be Performed by: Sample Approved? Yes/ No Reason for if not approved: Test Request Communication by: By courier with Letter Head, Verbal, Telephone or by mail Start Date: Completion Date: Sr. No. Type of test Parameters
  • 49. 34- QF-7-1-8- Review of requests, tenders & contracts
  • 50. 35- QF-6-2-2-Test Methods Specific tests / parameters performed * Test Method / Standard / Technique against which tests are performed/ Check Availability of latest version of standard copy Range of Testing / Limits of detection Turbidity IS 3025 (Part 10) 1NTU pH IS 3025 (Part 11) 6.5- 8.5 Total Hardness IS 3025 (Part 21) 200 mg/l Total dissolved solids IS 3025 (Part 16) 500 mg/l Iron IS 3025 (Part 53) 0.3 mg/l Chloride IS 3025 (Part 32) 250 mg/l Fluoride IS 3025 (Part 60) 1 mg/l Nitrate IS 3025 (Part 34) 45 mg/l Total alkalinity IS 3025 (Part 23) 200 mg/l Total Arsenic IS 3025 (Part 37) 0.01 mg/l Sulphate IS 3025 (Part 24) 200 mg/l Calcium IS 3025 (Part 40) 75.0mg/L Magnesium IS 3025 (Part 46) 30.0mg/L Phosphate Residual free chlorine IS 3025 (Part 26) 0.2 Aluminum IS 3025 (Part 55) 0.03 Copper IS 3025 (Part 42) 0.05 Manganese IS 3025 (Part 59) 0.1
  • 51. 36- QF-7-4-4-Sample retention and disposal register Sr. No Date Time Sample Description Sample ID Storage- Environmental Condition Retention Period Disposal Date Disposed by Remark
  • 55. 39- QF-7-7-1-IQC Plan (Individualized Quality Control)
  • 63. 47 - QF-7-10- Non- conforming testing report Sr. No. Date Report No./ Sample No. NC details Corrective action Root cause Changes made in samples/ report no.
  • 65. INTERESTED PARTIES SR. NO. INTERESTED PARTY INTERNAL OR EXTERNAL REASON FOR INTEREST (REQUIREMENTS/NEEDS/EXPECTATI ONS) Impact on the organizati on Approving authority Review Frequency Reviewed By 49 -QF-8-2-Context of Organization Category Context / Process / Interested Party Issues Type of Issue (Internal or External) Bias (Positive / Negative) Potential Effect Review Frequency Reviewed By 12 7 0 10 20 Positive Negative RESULT
  • 66. 50 - QF-8-3-1-List of External documents Sr No Doc Name Doc No Ref Amend No & Year Issue Date File No Received by
  • 67. 51 - QF-8-3-2 (a)-Issue and Approve control
  • 68. 52 - QF-8-4-2-Master List of Documents Sr. No Docum ent No Docum ent Title Docum ent Type Issu e No Issue Date Revisi on Date Revisi on No Owner / Custodi an Retenti on Period Storag e Locatio n Disposa l Method Disposal Authority Obsole te Copy Locatio n 1 QM- Lab- ASR-01 Quality Manual Manual 1 ##### ### - 0 Quality Manag er 3 Years Directo rs Cabin/ Cupbo ard No. 1 Shreddi ng ISO Representa tive Cupbo ard no.2
  • 70. 54 - QF-8-4-Records matrix Sr No Record No Record Title Retention Period Disposal Authority Method of Disposal Storage Location
  • 71. 55 - QF-8-5-Risks & Opportunity register XXXXX DISTRICT WATER TESTING LABORATORY - JAMMU RISK & OPPORTUNITY ASSESSMENT Sr. No. Process / Dept. Risk Description Risk Severity (S) Risk Probability (P) Risk Index (S X P = I) Risk Assessment Low (1-8), Medium (9-16), High (17-25) Mitigation Action Mitigation Action Type Opportunities Proposed Review Period 1 Personnel Lack of supervision or poor supervision 3 2 6 Low Already all available person's are comptent 3 All the staff would be made competent enough to handle lab activities themselves without supervision Yearly
  • 74. 58 - QF-8-8-2(a)-Internal Audit schedule ACTIVITY TO BE AUDITED FEB’21 MAR ’21 APR ’21 MAY ’21 JUN ’21 JUL ’21 AUG ’21 SEPT ’21 OCT ’21 NOV ’21 DEC ’21 JAN ’22 General Requirements Structural Requirements Resource Requirements Process Requirements Management System Requirements
  • 75. 59 -QF-8-8-2(b)-Internal Audit plan Sr. No. Date Time Dept Auditee Auditor
  • 76. 60 - QF-8-8-2(b-1)-Internal Audit checklist Clause Requirement Observations / Findings / Evidence C/NC/PC 4 General requirements 4.1 Impartiality