Documente Academic
Documente Profesional
Documente Cultură
Learning Objectives
Gain integrated perspective of quality in the lab
Laboratory Quality environment.
Understand the application of key quality concepts
Control & Assurance and statistical tools in labs.
Learn critical quality control and quality assurance
Integrated Approach activities.
Understand difference between registration and
Dr. Tariq A. Aldowaisan accreditation in labs via ISO 9001 & ISO 17025
models.
Dr. Ashraf S. Youssef
uality
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Quality Dimensions
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Population
A large No. of N
Plan Do
Mean = µ
Standard Deviation = σ
Sample
A small No. of n
Sample Mean = X
Sample Standard
Act Check Deviation = s
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S=
D X − X2
= 1 S=
∑D 2
n 2 2k
Where K = the number of sets of
duplicates
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Sp = i i
∑ν i
• Calculate S, and Sp
Where vi = the number of sets of
duplicates
Aldowaisan & Youssef Aldowaisan & Youssef
Sp =
n1 + n2 − 2
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Th simplest
The i l t regressioni analysis
l i ffor a straight
t i ht
a
line is called the least squares method of.
X
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Before Testing
MANAGEMENT
Receive Prepare Perform Analyze Prepare Give
Order Sample Test Results Report Report
QA
D i
During T
Testing
ti QMS
QC
Accuracy Checks
Results Monitoring
TECHNICAL
System & Performance Audit
Corrective Actions
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3 3
Rule 2: The last digit in a number is
assumed to be uncertain by +/- 1
unless otherwise specified. Which measurement is more precise?
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decimal point, and which also lies to Rule 2: When more than one digit is
the right of the first non-zero digit, to be dropped, Rule 1 is applied only
counts as a significant figure. one time to the first digit following
the last retained digit.
Significant figure is the number
0.0054070 Round two digits 1.047 =
are _________
8.35 - 0.365 =
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controlled conditions.
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www.iso.org
Aldowaisan & Youssef Aldowaisan & Youssef
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LRRC
UIREMENTS
UIREMENTS
SFACTION
SFACTION
info. flow management
responsibility QMS
CUSTOMER SATIS
CUSTOMER SATIS
CUSTOMER REQU
CUSTOMER REQU
Order Sample Test Results Report Report
resource meas., analysis info. flow
management improvement
Certify Administer
Auditors Audit
(Register)
NRB Standards
UKAS BSI
Employ
Train &
•DIT = Department of
Satisffy
Accredit
E
Register
i
Industry and Trade
ANSI Standards Accredit Certify Employ (Government)
RAB Registrars Organization Auditors Registrars
ASQ (Register) •UKAS = United
Kingdom Accreditation
Certify Service
(Register) •BSI = British
•ANSI = American National Standard Institute Standards Institute
•ASQ = American Society for Quality Audit Organization Satisfy •NRB = National
•RAB = Registrar Accreditation Board Registration Board
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GEOTECHNICAL
Valid To : December 31, 2005 Certificate Number: R-045 Valid To: March 31, 1999 CertificateNumber: 0036-02
In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to
this laboratory to perform the following tests under the ASTM recommended practice D3740:
This quality system meets the requirements of the ISO 9001:2000 standard for
mechanical and chemical testing (SIC 8734) on cold rolled and hot rolled steels. Soils:
ASTM: D420 D421 D422 D448 D558 D5 59 D560 D698 D854
D1140 D1452 D1556 D1557 D1587 D1883 D2166 D2167 D2216
D2217 D2419 D2434 D2435 D2487 D2488 D2850 D2922 D3017
D3282 D3668 D4219 D4221 D4318 D4429 D4546
Main Clause 5
Technical Competency Requirements
10 clauses • Testing & Accreditation Labs
ISO 17025 • Tests/Type of Tests
• Management + Technical
• Accreditation
• Assessor is field expert
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Requirements
JAB ISRAC
(Japan) (???) Proficiency Testing
www.ILAC.org
Receive Prepare Perform Analyze Prepare Give Receive Prepare Perform Analyze Prepare Give
Order Sample Test Results Report Report Order Sample Test Results Report Report
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________________
shall
shall
shall
shall
QM I
Work Instructions
Level
III
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Performance indices
authority
th it for
f issue.
i D fi iti
Definitions
Document change; i.e. revision date, rev. Forms/Records
no., total no. of pages, hand amendments,
computerized sys.
Supporting documents
Obsolete documents removal Flowcharts (Optional)
Obsolete documents retention policy
Documents access & availability
Sample: CETC SOP 150, 1 of 3
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The property charts monitor the process The precision charts monitor the process
mean. The basic two types of the Variability. There are three types:
property charts are: ¾ Individual charts ( MR-Chart )
¾ Individual charts ( X
X-chart
chart ) ¾ R
Range Ch
Chartt (R
(R-Chart)
Ch t)
¾ X-bar chart ¾ Standard deviation chart (S-Chart)
For the control chart for individual For the control chart for individual
measurements, the parameters measurements, the parameters for
are: − MR
−
MR are:
UCL = X + 3 −
d2 UCL = D 4 MR
−
−
CL = X CL = MR
−
− −
MR
LCL = X − 3 LCL = D 3 MR
d2
If Moving range of n=2, d2=1.128 D4=3.267, D3=0 for n = 2
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Teacher
Lab Performance Le
Nurse
Surgeon
Time
2nd Party
Corrective Office
Customer Surveillance
action audit
3rd Party audit
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OK
Review CAs
•Verify CA Implement
•Close NCR CA
Close-out
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Receive Prepare Perform Analyze Prepare Give Receive Prepare Perform Analyze Prepare Give
Order Sample Test Results Report Report Order Sample Test Results Report Report
Items Methods & Results Reporting Items Methods & Results Reporting
Sampling Sampling
Handling Validation QA Results Handling Validation QA Results
Training
•decreased competency in
•weak lab
the long run
run.
T
WEAK
K
•deteriorating lab.
WEAK EFFECTIVE
LOW HIGH L
E Selection
A
D
Competency E
R
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Competency assessment
Prior to developing a training plan
Time After completing the training program
4 Levels training assessment
Develop
Job-related
Train. Plan
Know your job (high detail)
Execute
Career-development-related
Personal skills
Assess Related subjects and skills
Plan
Writing Skills
Training
Verbal Skills
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To pioneer
Case Study For market advantage
To improve performance
ISO 17025 in CETC T anticipate
To ti i t future
f t
opportunities
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Receive application Review the Give Awareness Seminars 17 & 18 Nov. 2002
Screen 1
package application package Receive Application Packages 1 March 2003
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