QC Failure (in Arabic) By Dr. Tamer Soliman What is Quality Control? How to deal with Cases of Quality Control Failure

1. QC Failure‫ﺳﻠﻴﻤﺎن‬‫ﺗﺎﻣﺮ‬

2. ‫اﻷﺧﻄﺎء‬‫ﺑﺘﺤﺼﻞ‬‫ﰲ‬‫ﲨﻴﻊ‬‫ﻣﻌﺎﻣﻞ‬‫اﻟﻌﺎﱂ‬...
‫ﻣﺶ‬‫إﻧﺖ‬‫ﺑﺲ‬‫ﻳﻌﲏ‬...
...‫ﻫﱰﺗﺎح‬‫و‬‫ﺗﺮﻳﺢ‬‫اﻟﻠﻲ‬‫ﺷﻐﺎﻟﲔ‬‫ﻣﻌﺎﻫﺎ‬‫واﻟﻠﻲ‬‫ﺑﻴﻌﻤﻠﻮا‬‫ﲢﺎﻟ‬‫ﻴﻞ‬‫ﻋﻨﺪﻫﺎ‬
...‫ﻣﺶ‬‫ﻫﺘﺴﺒﺐ‬‫ﻣﺸﺎﻛﻞ‬‫ﻟﻠﻤﺮﺿﻰ‬
...‫وﻫﺘﻮﻓﺮ‬‫ﰲ‬‫وﻗﺘﻬﺎ‬‫و‬‫ﺟﻬﺪﻫﺎ‬‫و‬‫ﻓﻠﻮﺳﻬﺎ‬
‫واﳌﻌﺎﻣﻞ‬‫اﻟﻠﻲ‬‫ﻋﻨﺪﻫﺎ‬‫إﺟﺮاءات‬‫ﳏﺪدة‬‫ﻟﻠﺘﻌﺎﻣﻞ‬‫ﻣﻊ‬‫اﳌﺸﺎﻛﻞ‬‫اﻟﻠﻲ‬‫زي‬‫دي‬‫وﺗﺼﺤﻴﺤﻬﺎ‬

3. ‫اﳉﻮدة؟‬‫ﺿﺒﻂ‬‫ﻫﻮ‬‫إﻳﻪ‬
‫ﺑﺈﺧﺘﺼﺎر‬‫اﻟﻄﺒﻴﺔ‬‫اﳌﻌﺎﻣﻞ‬‫ﰲ‬‫اﳉﻮدة‬‫ﺿﺒﻂ‬...‫ﻋﻤﻠﻴﺔ‬‫ﻫﻲ‬‫إﺣﺼﺎﺋﻴﺔ‬
‫ﳌ‬‫ﺗﺴﺘﺨﺪم‬‫ﺮاﻗﺒﺔ‬‫و‬‫ﺗﻘﻴﻴﻢ‬‫اﻟﺘﺤﺎﻟﻴﻞ‬‫إﺟﺮاء‬‫ﻋﻤﻠﻴﺔ‬‫اﻵ‬‫ﰲ‬‫ﺑﺘﺪﻳﻨﺎ‬‫اﻟﱵ‬‫اﳌﺮﺿﻰ‬‫ﻧﺘﺎﺋﺞ‬ ‫ﺧﺮ‬.
‫اﳉﻮدة‬‫ﺿﺒﻂ‬‫ﻋﻤﻠﻴﺔ‬‫ﻣﺘﻄﻠﺒﺎت‬
‫اﻟﻜﻨﱰوﻻت‬‫إدﺧﺎل‬
‫ﻣﻨﺘﻈ‬‫دورﻳﺔ‬‫ﺑﻄﺮﻳﻘﺔ‬‫ﻤﺔ‬
‫اﳌﺮﺿ‬‫ﻋﻴﻨﺎت‬‫ﻗﺒﻞ‬‫ﻰ‬
‫اﻟﻜﻨﱰوﻻت‬‫ﻣﻘﺎرﻧﺔ‬
‫ﺑﻪ‬‫اﳌﺴﻤﻮح‬‫اﻹﺣﺼﺎﺋﻲ‬‫ﺑﺎﳌﺪى‬

4. ‫ﻣﻘﺪﻣﺔ‬
Actual Concentration
Measuredvalue
50
50
10
10
0
0
Regression Line
‫اﻹﳓﺪار‬‫ﺧﻂ‬
403020
30
20
40

5. Affects Precision
Analytical
Errors
‫ﻣﻘﺪﻣﺔ‬
Random
Error
Systematic
Error
Affects Accuracy
‫ﻧﻈﺎﻣﻲ‬‫ﻋﺸﻮاﺋﻲ‬
Constant
Systematic
Error
Proportional
Systematic
Error
(Repeatability) (Trueness)
‫ﺗﺮﻛﻴﺰ‬‫ﻣﻊ‬‫ﻋﻦ‬‫اﻟﻨﻈﺮ‬‫ﺑﻐﺾ‬
Analytical
Errors
‫ﺛﺎﺑﺖ‬
‫ال‬‫ﺗﺮﻛﻴﺰ‬analytes
‫ﻣﺘﻨﺎﺳﺐ‬
‫ال‬analytes
Analytical
Errors
Pre
Analytical
Errors
Post
Laboratory Errors

6. ‫ﺛﺎﺑﺖ‬‫ﳕﻂ‬‫ﻣﺎﳍﻮش‬
= imprecision
= Lack of reproducibility
= Lack of repeatability
Random error has no inherent pattern
and refer to the random dispersion of
results or measurements around some
point of central tendency
Random Error
Measuredvalue
50
10
0
30
20
40
Actual Concentration
50100 403020
Analytical
Errors
‫ﻣﻘﺪﻣﺔ‬
Random
Error
Causes: 1. Instability of the instrument
2. Variations in temperature
3. Variability in handling techniques such as pipetting, mixing and timing
4. Variability in operators

7. Actual Concentration
Measuredvalue
50
50
10
0
403020
30
20
40
y
x
+10
-10
‫ال‬‫ﳏﻮر‬‫ﻗﻄﻊ‬)y(
Analytical
Errors
‫ﻣﻘﺪﻣﺔ‬
‫ﲟﻘﺪار‬‫ﻣﻨﺨﻔﺾ‬‫أو‬‫ﻣﺮﺗﻔﻊ‬‫إﻣﺎ‬‫اﳋﻄﺄ‬‫ﺛﺎﺑ‬‫ﺖ‬ ‫اﻟﱰﻛﻴﺰ‬‫ﻋﻦ‬‫اﻟﻨﻈﺮ‬‫ﺑﻐﺾ‬
The error is either high or low by the
same amount (magnitude) regardless
of the concentration
The y-intercept has increased or decreased
whereas the slope has remained the same.
Constant
Systematic
Error

8. Actual Concentration
Measuredvalue
50
50
10
0
403020
30
20
40
y
x
1. An interfering substance that gives rise to a false signal. This may be due to
lack of specificity of the method used.
2. Improper blanking of the sample or the reagents.
‫ﲟﻘﺪار‬‫ﻣﻨﺨﻔﺾ‬‫أو‬‫ﻣﺮﺗﻔﻊ‬‫إﻣﺎ‬‫اﳋﻄﺄ‬‫ﺛﺎﺑ‬‫ﺖ‬ ‫اﻟﱰﻛﻴﺰ‬‫ﻋﻦ‬‫اﻟﻨﻈﺮ‬‫ﺑﻐﺾ‬
The y-intercept has increased or decreased
whereas the slope has remained the same.
Analytical
Errors
‫ﻣﻘﺪﻣﺔ‬
Causes:
The error is either high or low by the
same amount (magnitude) regardless
of the concentration
Constant
Systematic
Error

9. 1. Problems with the calibrator
2. Side reaction of the analyte
‫ﻣﻨﺨﻔﺾ‬‫أو‬‫ﻣﺮﺗﻔﻊ‬‫إﻣﺎ‬‫اﳋﻄﺄ‬
‫ﲟﻘﺪار‬‫ﻳﻨﺘﺎﺳﺐ‬‫اﻟﱰ‬‫ﻣﻊ‬‫ﻛﻴﺰ‬
The error is either high or low by an
amount (magnitude) proportional to
the analyte concentration.
Slope ≠ 1.0
Analytical
Errors
‫ﻣﻘﺪﻣﺔ‬
Proportional
Systematic
Error
Causes: (Erroneous calibration is the most frequent cause)
Actual Concentration
5010 403020
x
Measuredvalue
50
0
30
20
40
y
10

10. Analytical
Errors
‫ﻣﻘﺪﻣﺔ‬
Combined Systematic Error
= both constant and proportional
Actual Concentration
5010 403020
x
Measuredvalue
50
0
30
20
40
y
10

11. Observed
value
Target (True)
value
μX Values
(Results)
Patients
Random Error
Systematic Error (Bias)
X – μ
Total Error
(Mean)
Total Error = Random Error (ER) + Systematic Error (SE)
‫اﻟﻜﻠﻲ‬‫اﳋﻄﺄ‬
(Bias)
Affect Precision
Affect Accuracy
‫ﻣﻘﺪﻣﺔ‬
Total Analytic Error (TAE)

12. Measuredvalue
50
10
0
30
20
40
Actual Concentration
50100 403020
Error Grid
‫اﻹﻛﻠﻴﻨﻴﻜﻲ‬‫اﻟﺘﺄﺛﲑ‬‫ﻧﻔﺲ‬‫ﳍﺎ‬‫اﻟﻘﻴﺎس‬‫أﺧﻄﺎء‬‫ﻛﻞ‬‫ﻟﻴﺲ‬.
...‫اﻷﺧﻄﺎء‬‫اﻟﺼﻐﲑة‬‫ﹰ‬‫ﻧﺎدرا‬‫ﻣﺎ‬‫ﲤﺜﻞ‬‫ا‬
‫ﹰ‬
‫ﺿﺮر‬‫ﺑﺎﳌﻘﺎرﻧﺔ‬‫ﺑﺎﻷﺧﻄﺎء‬‫اﻟ‬‫ﻜﺒﲑة‬
...‫وﺣﱴ‬‫ﻟﻮ‬‫وﻗﻊ‬‫ﺿﺮر‬‫ﻧﺎﺟﻢ‬‫ﻋﻦ‬‫اﻷﺧﻄﺎء‬‫اﻟﺼﻐﲑة‬‫ﻏﺎﻟﺒﺎ‬‫ﻣﺎﻳﺒﻘﻰ‬‫ﺿ‬‫ﺮر‬‫أﻗﻞ‬
‫ﺧﻄﻮرة‬.
measurement
errors
‫اﻷﺧﻄﺎء‬‫ﺷﺒﻜﺔ‬
Y
X
‫ﻟﺘﻤﺜﻴﻞ‬‫ﻫﺬا‬،‫اﻻﺧﺘﻼف‬‫ﰎ‬‫ﺗﺼﻤﻴﻢ‬‫ال‬Error Grid‫اﻟﻠﻲ‬‫ﺑﺘﺸﺘﻤﻞ‬
‫ﻋﻠﻰ‬‫أﻛﱰ‬‫ﻣﻦ‬‫ﻣﻨﻄﻘﺔ‬
‫اﻟﻘﻴﺎس‬‫ﳋﻄﺄ‬‫اﻹﻛﻠﻴﻨﻴﻜﻲ‬‫اﻟﺘﺄﺛﲑ‬
Clinical impact of measuring error
‫أﺧﻄﺎء‬
‫ﻗﻴﺎس‬‫ﰲ‬
‫اﻟﻨﺘﻴﺠﺔ‬
‫ﳐﺘﻠﻒ‬
‫ﻟﻠﻤﺮﻳﺾ‬
‫ﺿﺮر‬ ‫ﻗﺮار‬
‫ﻃﱯ‬
‫ﳐﺘﻠﻒ‬
ErrorDecisionHarm
C
C
B
B A

13. Measuredvalue
50
10
0
30
20
40
Actual Concentration
50100 403020
C
C
B
B
Error Grid
Y
X
A
‫اﻷﺧﻄﺎء‬‫ﺷﺒﻜﺔ‬
Zone A: ATE or TEa (Allowable Total Error) zone.
• The innermost zone containing the Y = X line
• Should contain a high percentage of results (≥ 95%).
• Zone A is defined as the region where:
… Differences are small enough to be considered
clinically acceptable (measurements lead to the
same treatment decision).
… May also include small differences that
sometimes result in slightly altered treatment
decisions but without the likelihood of potential
patient harm.
Examples of Allowable total errors TEa
ATE

14. Measuredvalue
50
10
0
30
20
40
Actual Concentration
50100 403020
Zone B:
• Intermediate zone between Zones A and C.
• It represents errors of moderate magnitude that
could result in altered clinical response, with the
likelihood of minor potential harm to the patient.
• Ideally, this zone should contain < 5% of the data.
Error Grid
Y
X
‫اﻷﺧﻄﺎء‬‫ﺷﺒﻜﺔ‬
C
C
B
B A

15. Measuredvalue
50
10
0
30
20
40
Actual Concentration
50100 403020
Zone C: LER (Limits of Erroneous Results) zone.
• This is the outer zone
• Should ideally contain no data.
• Zone C is defined as the region where:
… The magnitude of the error is so large
… it could lead to erroneous treatment decisions
… Potential to cause significant patient harm.
LER
LER
Error Grid
Y
X
Zone C will include regions both above (overestimation) and
below (underestimation) the Y = X line.
The overestimation and underestimation zones generally have
different implications for the patient as they lead to different
kinds of treatment error.
Sometimes, it may be appropriate to divide the LER zone into
3 or more zones corresponding to degrees of patient harm.
The zones are then labeled as Zone C, D, etc. (higher letters
= more severe potential patient harm).
C
C
B
B A

16. Clinical sensitivity is different from analytical sensitivity.
Analytical sensitivity is defined as the ability of the assay
to detect the presence of the target substance
Clinical sensitivity refers to the association of the target
substance, once detected, with actual disease state.

17. Controls (Control Material)
Definition: Specimens that are analyzed for QC purpose.
• Similar in composition to the patient’s whole blood or plasma.
• The value of a control specimen is known.
• A control specimen must be carried through the entire test procedure
= treated in exactly the same way as any unknown specimen;
= must be affected by all the variables that affect the unknown specimen.
• Control specimens are tested daily or in conjunction with the unknown patient specimen.
• Controls are the best measurements of precision.
(noun)

18. Suitable Control Criteria
1. Safe
2. Stable
3. Have a matrix similar to that of the test specimens,
e.g., a protein matrix is best when serum is the test material.
4. Available in aliquots or vials of suitable size
5. With little vial-to-vial variability
6. Can be analyzed periodically over a long time
(at least one year, in order to decrease the cost of recalculation of the mean and
standard deviation with new lots).
7. Analyte concentration should be in the normal and abnormal ranges, corresponding
to those met in critical medical situations.
Controls (Control Material)
(noun)

19. Available preparations of Control Materials
Controls (Control Material)
(noun)
Source of Control Materials (Matrix)
• Human-based: Better, carry the Risk of hepatitis and Expensive
• Animal-Based (Bovine): More available, Safer and Cheaper
• Either lyophilized (reconstituted with water or diluent) or liquid (ready for use).
Finally, control materials are either assayed or unassayed.
Lyophilized Materials Low-Temperature Liquid Material
Less Expensive
Human Matrix
More Expensive
Human / Bovine Matrix
Short stability after reconstitution Long stability (No reconstitution)
(cheaper price)

20. Quality Assurance Quality Control
Management system
to guarantee integrity of data.
Measurement system
Used to check quality of analytical data.
Everybody’s business Restricted to a specific area
Performed by authorized staff
Goal is value addition Goal is error prevention
Management strategy Error detection methodology
‫اﻟﺒﻴﺎﻧﺎت‬‫ﺳﻼﻣﺔ‬

21. ‫ذ‬
‫إﻟﻴﻚ‬‫ﺑﻌﺾ‬‫اﻟﻨﺼﺎﺋﺢ‬‫اﳌﻔﻴﺪة‬‫اﻟﻠﻲ‬‫ﳑﻜﻦ‬‫ﺗﺴﺘﺨﺪﻣﻬﺎ‬‫ﰲ‬‫اﳌﻌ‬‫ﻤﻞ‬‫ﺑﺘﺎﻋﻚ‬‫ﻋﺸﺎن‬
‫ﺗﻀﻤﻦ‬‫إن‬‫اﻹﺟﺮاءات‬‫اﱄ‬‫ﻫﺘﺘﺨﺬﻫﺎ‬‫ﺳﻠﻴﻤﺔ‬‫وﻓﻌﺎﻟﺔ‬‫ﰲ‬‫ﻧﻔﺲ‬‫ذات‬‫اﻟﻮﻗﺖ‬.
‫اﻟﺼﺤﻴﺢ‬‫وﺿﻌﻬﺎ‬‫ﰲ‬‫اﳌﺸﻜﻠﺔ‬‫ﺿﻊ‬
‫ﺗﺼﺤﻴﺤﻪ‬‫ﰲ‬‫اﻟﺒﺪء‬‫و‬‫اﻟﺴﺒﺐ‬‫اﺳﺘﻜﺸﺎف‬‫ﻗﺒﻞ‬
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings
‫ﺗﻔﻬﻢ‬‫ﻋﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺑﺈﺧﺘﺼﺎر‬
‫ارﺑﻂ‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﻟﻴﻪ‬‫اﶈﺘﻤﻠﺔ‬‫ﺑﺎﻷﺳﺒﺎب‬
‫اﻟﺘﺼﺤﻴﺤﻴﺔ‬‫اﻹﺟﺮاءات‬‫ﺗﻨﻔﻴﺬ‬
‫ﻓﺎﻋﻠﻴﺘﻬﺎ‬‫واﻟﺘﺤﻘﻖ‬...‫اﳊﻞ‬‫ﺗﻮﺛﻴﻖ‬‫و‬
‫ﹰ‬‫أوﻻ‬
‫ﺛﺎﻧﻴﺎ‬
‫ﺛﺎﻟﺜﺎ‬
‫راﺑﻌﺎ‬‫ﻛﺪه‬‫ﺑﻌﺪ‬‫ﺗﺮﺟﻌﻠﻪ‬‫ﺣﺒﻴﺖ‬‫ﻟﻮ‬‫ﻋﺸﺎن‬

22. Put the problem into perspective
before you begin troubleshooting
‫ﺗﺼﺤﻴﺤﻪ‬‫ﰲ‬‫اﻟﺒﺪء‬‫و‬‫اﻟﺴﺒﺐ‬‫اﺳﺘﻜﺸﺎف‬‫ﻗﺒﻞ‬‫اﻟﺼﺤﻴﺢ‬‫ﻣﻜﺎﻧﻬﺎ‬‫ﰲ‬‫اﳌﺸﻜﻠﺔ‬‫وﺿﻌﻬﺎ‬
‫ﻻ‬‫أم‬‫ﻓﻌﻼ‬‫ﺧﻄﺄ‬‫ﻫﻲ‬‫ﻫﻞ‬
‫ﻻ‬‫أم‬‫أﻫﻤﻴﺔ‬‫ذا‬‫ﺧﻄﺄ‬‫ﻫﻲ‬‫ﻫﻞ‬
1

23. Error or NOT
‫اﻟﺼﺤﻴﺢ‬‫وﺿﻌﻬﺎ‬‫ﰲ‬‫اﳌﺸﻜﻠﺔ‬‫ﺿﻊ‬...
‫ﺗﺼﺤﻴﺤﻪ‬‫ﰲ‬‫اﻟﺒﺪء‬‫و‬‫اﻟﺴﺒﺐ‬‫اﺳﺘﻜﺸﺎف‬‫ﻗﺒﻞ‬
‫أوﻻ‬

24. ‫ﻫﻞ‬‫ده‬‫ﻳﺴﺘﺪﻋﻲ‬‫ﻣﻨﻨﺎ‬‫ﻧﺮﻓﺾ‬‫ال‬RUN‫ﻋﻠﻰ‬‫اﳉﻬﺎز‬
...‫وﻧﺮﻓﺾ‬‫ﻛﻞ‬‫ﻧﺘﺎﺋﺞ‬‫اﳌﺮﺿﻰ‬‫اﻟﻠﻲ‬‫ﻃﻠﻌﺖ‬
...‫وﻧﺼﺤﺢ‬‫اﳌﺸﻜﻠﺔ‬‫دي‬‫ﻗﺒﻞ‬‫أي‬‫ﺷﻲء‬
‫اﻟﺼﺤﻴﺢ‬‫وﺿﻌﻬﺎ‬‫ﰲ‬‫اﳌﺸﻜﻠﺔ‬‫ﺿﻊ‬...
‫ﺗﺼﺤﻴﺤﻪ‬‫ﰲ‬‫اﻟﺒﺪء‬‫و‬‫اﻟﺴﺒﺐ‬‫اﺳﺘﻜﺸﺎف‬‫ﻗﺒﻞ‬
‫إﺣﻨﺎ‬‫ﳔﺎف‬‫ﻧﻮﻗﻒ‬‫ال‬RUN‫ﻋﻠﻰ‬‫اﳉﻬﺎز‬‫و‬‫ﻧﺮﻓﺾ‬‫اﻟﻨﺘﺎﺋﺞ‬
...‫وﻣﻨﻼﻗﻴﺶ‬‫ﻣﺸﻜﻠﺔ‬‫ﰲ‬‫اﻵﺧﺮ‬
...‫ودي‬‫ﺑﻴﺴﻤﻮﻫﺎ‬‫اﻟﺮﻓﺾ‬‫اﳋﺎﻃﻲء‬)False Rejection(
...‫وﻫﺘﺒﻘﺎ‬‫وﻗﺘﻬﺎ‬‫ﺿﻴﻌﻨﺎ‬‫وﻗﺖ‬‫و‬‫ﺟﻬﺪ‬‫وﻓﻠﻮس‬‫ع‬‫اﻟﻔﺎﺿﻲ‬
)‫اﳌﻮﺿﻮع‬‫أﺻﺒﺢ‬‫ﻣﻜﻠﻒ‬‫ﺟﺪا‬‫ﺧﺎﺻﺔ‬‫ﺑﻌﺪ‬‫ﺗﻌﻮﱘ‬‫اﳉﻨﻴﻪ‬(
‫ﺑﺈﺧﺘﺼﺎر‬‫ﻳﻌﲏ‬...‫ال‬‫ﻇﻬﻮر‬‫ﺑﻌﺪ‬FLAG‫ﻣﻀﺒﻮﻃﺔ‬‫ﻣﺶ‬‫اﻟﻜﻨﱰول‬‫ﻗﺮاءة‬‫إن‬‫ﺑﻴﻘﻮﻟﻚ‬‫اﻟﻠﻲ‬
‫ﺑﺲ‬‫ﳔﺎف‬‫وإﺣﻨﺎ‬‫ﺑﻨﺘﺎﺑﻊ‬
...‫ﻧﻼﻗﻲ‬‫ﻇﻬﺮ‬‫ﻟﻨﺎ‬‫ﻣﺸﻜﻠﺔ‬‫ﻛﺒﲑة‬‫ﻣﻜﻨﺎش‬‫واﺧﺪﻳﻦ‬‫ﺑﺎﻟﻨﺎ‬‫ﻣ‬‫ﻨﻬﺎ‬
...‫وأن‬‫ﻛﻞ‬‫اﻟﻨﺘﺎﺋﺞ‬‫ﻃﻠﻌﺖ‬‫ﻓﻴﻬﺎ‬‫ﻧﺴﺒﺔ‬‫أﺧﻄﺎء‬
...‫وﳑﻜﻦ‬‫ده‬‫ﻳﻀﺮ‬‫ﺑﺎﳌﺮﺿﻲ‬
...‫وﻧﻨﺪم‬‫وﻗﺖ‬‫ﻻ‬‫ﻳﻨﻔﻊ‬‫اﻟﻨﺪم‬
‫وﻻ‬‫ﳔﻠﻲ‬‫اﻟﺪﻧﻴﺎ‬‫ﲤﺸﻲ‬‫ﻋﺎدي‬
...‫وﻧﻘﺒﻞ‬‫اﻟﻨﺘﺎﺋﺞ‬
...‫و‬‫ﻧﻜﺘﻔﻲ‬‫ﺑﺲ‬‫ﺑﺎﳌﺘﺎﺑﻌﺔ‬‫واﳌﻼ‬‫ﺣﻈﺔ‬
‫أوﻻ‬

25. your Levey-Jennings charts
to understand the Type of error that has occurred
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings:‫ﺣﺼﻞ‬‫اﻟﺬي‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺗﻔﻬﻢ‬‫ﻋﺸﺎن‬
2
Review

26. 0.1%
34.1%
2.1%
13.6%
34.1%
13.6%
2.1%
0.1%
+2sMean-2s +3s+1s-3s -1s +4s-4s
Normal Distribution Curve
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫اﻟﻄﺒﻴﻌﻲ‬‫اﻟﺘﻮزﻳﻊ‬‫ﻣﻨﺤﲎ‬
‫ﺛﺎﻧﻴﺎ‬
= Gaussian curve
= Normal Probability curve
• Continuous
• Symmetric (around the mean)
M
μ
X
• Intervals on both sides of the mean
expressed in Standard Deviation
σ
SD
S
‫دي‬‫إس‬
‫إس‬
‫ﺳﻴﺠﻤﺎ‬
‫ﻣﻴﻮ‬
‫ﺑﺎر‬‫اﻛﺲ‬
‫إم‬

27. ‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
+2sMean-2s +3s+1s-3s -1s-4s +4s +5s +6s-5s-6s
+2SD-2SD +3SD+1SD-3SD -1SD-4SD +4SD +5SD +6SD-5SD-6SD X
μ +2σ-2σ +3σ+1σ-3σ -1σ-4σ +4σ +5σ +6σ-5σ-6σ
Normal Distribution Curve‫اﻟﻄﺒﻴﻌﻲ‬‫اﻟﺘﻮزﻳﻊ‬‫ﻣﻨﺤﲎ‬
= Gaussian curve
= Normal Probability curve
• Continuous
• Symmetric (around the mean)
• Mean = Median = Mode
• Intervals on both sides of the mean expressed in Standard Deviation
σ
SD
S
‫دي‬‫إس‬
‫إس‬
‫ﺳﻴﺠﻤﺎ‬
M
μ
X
‫ﻣﻴﻮ‬
‫ﺑﺎر‬‫اﻛﺲ‬
‫إم‬

28. ‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
+2sMean-2s +3s+1s-3s -1s-4s +4s +5s +6s-5s-6s
+2SD-2SD +3SD+1SD-3SD -1SD-4SD +4SD +5SD +6SD-5SD-6SD X
μ +2σ-2σ +3σ+1σ-3σ -1σ-4σ +4σ +5σ +6σ-5σ-6σ
Normal Distribution Curve‫اﻟﻄﺒﻴﻌﻲ‬‫اﻟﺘﻮزﻳﻊ‬‫ﻣﻨﺤﲎ‬
= Gaussian curve
= Normal Probability curve
2.1% 34.1% 13.6% 0.1%34.1%13.6% 2.1%0.1%
68.2%
95.4%
97.2%
99.4%
99.977%
99.99964%

29. 0.1%
0.1%
2.1%
34.1%
13.6%
34.1%
13.6%
2.1%
68.2% 95.4% 99.7% 99.99%
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
+2s
Mean
-2s
+3s
+1s
-3s
-1s
+4s
-4s
+2s
Mean
-2s
+3s
+1s
-1s
-4s
-3s
+4s

30. 0.1%
0.1%
2.1%
34.1%
13.6%
34.1%
13.6%
2.1%
Levey-Jennings Chart
‫ﻟﻴﻔﻲ‬‫ﳐﻄﻂ‬–‫ﺟﻴﻨﻨﺞ‬
‫ﻟﺘﺒﺴﻴﻂ‬‫ﻣﺮاﺟﻌﺔ‬‫ﺑﻴﺎﻧﺎت‬‫ﻣﺮاﻗﺒﺔ‬،‫اﳉﻮدة‬
‫ﺗﻘﻮم‬‫أﻏﻠﺐ‬‫اﳌﻌﺎﻣﻞ‬‫ﺑﻌﺮﺿﻬﺎ‬‫ﻋﻠﻰ‬‫ﳐﻄﻂ‬Levey-Jennings
̶‫وﻫﻮ‬‫ﲤﺜﻴﻞ‬‫ﺑﻴﺎﱐ‬‫ﻟﻠﻨﺘﺎﺋﺞ‬‫ﺧﻼل‬‫ﻓﱰة‬‫زﻣﻨﻴﺔ‬‫ﻣﻌ‬‫ﻴﻨﺔ‬.
‫ﲝﻴﺚ‬‫ﻳﺒﻘﺎ‬‫ﻣﻦ‬‫اﻟﺴﻬﻞ‬:
...‫ﲢﺪﻳﺪ‬‫اﻟﻘﻴﻢ‬‫اﳋﺎرﺟﻴﺔ‬‫واﻻﲡﺎﻫﺎت‬‫واﻟﺘﺤﻮﻻت‬‫ﰲ‬‫اﻟﺒﻴﺎﻧﺎت‬
...‫اﻟﻮﺻﻮل‬‫ﻟﻠﻬﺪف‬‫اﻟﻨﻬﺎﺋﻲ‬‫اﳌﺘﻤﺜﻞ‬‫ﰲ‬‫إﻇﻬﺎر‬‫ﻣﺎ‬‫إذا‬‫ﻛ‬‫ﺎﻧﺖ‬
‫ﻋﻤﻠﻴﺔ‬‫إﺟﺮاء‬‫اﻟﺘﺤﺎﻟﻴﻞ‬‫ﺑﺎﳌﻌﻤﻞ‬‫ﺗﻌﻤﻞ‬‫ﺑﺸﻜﻞ‬‫ﺻﺤ‬‫ﻴﺢ‬‫أم‬‫ﻻ‬
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
+2s
Mean
-2s
+3s
+1s
-3s
-1s
+4s
-4s
+2s
Mean
-2s
+3s
+1s
-1s
+4s
-4s
-3s

31. Levey-Jennings Chart
‫ﻟﻴﻔﻲ‬‫ﳐﻄﻂ‬–‫ﺟﻴﻨﻨﺞ‬
‫ﻳﺘﻢ‬‫رﺳﻢ‬‫اﻟﺒﻴﺎﻧﺎت‬‫ﻋﻠﻰ‬‫ﳐﻄﻂ‬‫ﻣﻜﻮن‬‫ﻣﻦ‬٧‫ﺧﻄﻮط‬‫أﻓﻘﻴﺔ‬:
•‫اﳋﻂ‬‫اﻟﻠﻲ‬‫ﰲ‬‫اﻟﻨﺺ‬‫ﳝﺜﻞ‬‫اﳌﺘﻮﺳﻂ‬mean
)‫وﻳﺮﻣﺰ‬‫ﻟﻴﻪ‬‫ﺑﺎﻟﺮﻣﺰ‬M‫أو‬x̅(
•‫و‬‫اﻟﺴﺘﺔ‬‫اﻵﺧﺮﻳﻦ‬‫ﻳﺸﲑوا‬‫إﱃ‬
‫ﻗﻴﻢ‬‫اﻹﳓﺮاف‬‫اﳌﻌﻴﺎري‬‫أو‬standard deviation
‫ﻋﻨﺪ‬1s‫و‬2s‫و‬3s
...‫ﹰ‬‫ﺳﻮاءا‬‫أﻋﻠﻰ‬‫ﺧﻂ‬‫اﳌﺘﻮﺳﻂ‬...)‫ﺑﺎﳌﻮﺟﺐ‬(
...‫أو‬‫أﺳﻔﻞ‬‫ﺧﻂ‬‫اﳌﺘﻮﺳﻂ‬...)‫ﺑﺎﻟﺴﺎﻟﺐ‬(.
M
+3s
+2s
-2s
+1s
-1s
-3s
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
+2s
Mean
-2s
+3s
+1s
-3s
-1s
+4s
-4s
+2s
Mean
-2s
+3s
+1s
-1s
+4s
-4s
-3s

32. ‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
Levey-Jennings Chart
‫ﻟﻴﻔﻲ‬‫ﳐﻄﻂ‬–‫ﺟﻴﻨﻨﺞ‬
‫ﻻ‬‫ﻳﺘﻄﻠﺐ‬‫اﻷﻣﺮ‬‫ﺳﻮى‬‫ﻧﻈﺮة‬‫ﺳﺮﻳﻌﺔ‬‫ﻋﻠﻰ‬‫اﻟﺮﺳﻢ‬‫اﻟﺒﻴ‬‫ﺎﱐ‬‫ﳌﻌﺮﻓﺔ‬
‫إذا‬‫ﻛﺎن‬‫ﻫﻨﺎك‬...
•‫ﻗﻴﻤﺔ‬‫ﻣﺘﻄﺮﻓﺔ‬outlier‫ﺗﻘﻊ‬‫ﺧﺎرج‬‫اﻟﻨﻄﺎق‬‫اﳌﻘﺒﻮل‬)±3S(
x
x
x
x
x
outlier
x
x
x
+2s
Mean
-2s
+3s
+1s
-3s
-1s
+4s
-4s
+2s
Mean
-2s
+3s
+1s
-1s
+4s
-4s
-3s

33. +2s
Mean
-2s
+3s
+1s
-3s
-1s
+4s
-4s
+2s
Mean
-2s
+3s
+1s
-1s
+4s
-4s
Levey-Jennings Chart
‫ﻟﻴﻔﻲ‬‫ﳐﻄﻂ‬–‫ﺟﻴﻨﻨﺞ‬
‫ﻻ‬‫ﻳﺘﻄﻠﺐ‬‫اﻷﻣﺮ‬‫ﺳﻮى‬‫ﻧﻈﺮة‬‫ﺳﺮﻳﻌﺔ‬‫ﻋﻠﻰ‬‫اﻟﺮﺳﻢ‬‫اﻟﺒﻴ‬‫ﺎﱐ‬‫ﳌﻌﺮﻓﺔ‬
‫إذا‬‫ﻛﺎن‬‫ﻫﻨﺎك‬...
•‫ﻗﻴﻤﺔ‬‫ﻣﺘﻄﺮﻓﺔ‬outlier‫ﺗﻘﻊ‬‫ﺧﺎرج‬‫اﻟﻨﻄﺎق‬‫اﳌﻘﺒﻮل‬)±3S(
•‫أو‬‫إذا‬‫ﻛﺎن‬‫ﻫﻨﺎك‬‫أي‬‫ﲢﻮل‬‫ﰲ‬‫اﻟﻨﺘﺎﺋﺞ‬Shift
)‫ﺣﺮﻛﺔ‬‫ﻣﻔﺎﺟﺌﺔ‬‫ﲢﺪث‬‫ﻓﻴﻬﺎ‬١٠‫ﻧﻘﺎط‬‫ﺑﻴﺎﻧﻴﺔ‬‫أو‬‫أﻛﺜﺮ‬‫ﻣﺘﺘﺎﻟ‬‫ﻴﺔ‬
‫ﲨﻴﻌﻬﺎ‬‫ﻓﻮق‬‫أو‬‫ﲢﺖ‬‫اﳌﺘﻮﺳﻂ‬(
-3s
x
x
x
xx
x
x
x
xx
x
x
Shift
= Sudden
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
x

34. Levey-Jennings Chart
‫ﻟﻴﻔﻲ‬‫ﳐﻄﻂ‬–‫ﺟﻴﻨﻨﺞ‬
‫ﻻ‬‫ﻳﺘﻄﻠﺐ‬‫اﻷﻣﺮ‬‫ﺳﻮى‬‫ﻧﻈﺮة‬‫ﺳﺮﻳﻌﺔ‬‫ﻋﻠﻰ‬‫اﻟﺮﺳﻢ‬‫اﻟﺒﻴ‬‫ﺎﱐ‬‫ﳌﻌﺮﻓﺔ‬
‫إذا‬‫ﻛﺎن‬‫ﻫﻨﺎك‬...
•‫ﻗﻴﻤﺔ‬‫ﻣﺘﻄﺮﻓﺔ‬outlier‫ﺗﻘﻊ‬‫ﺧﺎرج‬‫اﻟﻨﻄﺎق‬‫اﳌﻘﺒﻮل‬)±3S(
•‫أو‬‫إذا‬‫ﻛﺎن‬‫ﻫﻨﺎك‬‫أي‬‫ﲢﻮل‬‫ﰲ‬‫اﻟﻨﺘﺎﺋﺞ‬Shift
)‫ﺣﺮﻛﺔ‬‫ﻣﻔﺎﺟﺌﺔ‬‫ﲢﺪث‬‫ﻓﻴﻬﺎ‬١٠‫ﻧﻘﺎط‬‫ﺑﻴﺎﻧﻴﺔ‬‫أو‬‫أﻛﺜﺮ‬‫ﻣﺘﺘﺎﻟ‬‫ﻴﺔ‬
‫ﲨﻴﻌﻬﺎ‬‫ﻓﻮق‬‫أو‬‫ﲢﺖ‬‫اﳌﺘﻮﺳﻂ‬(
•‫أو‬‫ﺗﻐﻴﲑ‬‫ﰲ‬‫اﻹﲡﺎه‬Trend
)‫ﺣﺮﻛﺔ‬‫ﺗﺪرﳚﻴﺔ‬‫ﰲ‬‫اﲡﺎه‬‫واﺣﺪ‬،‫إﻣﺎ‬‫ﻟﻸﻋﻠﻰ‬‫أو‬‫ﻟﻸﺳ‬‫ﻔﻞ‬،‫ﻣﻦ‬
‫ﺧﻼل‬‫ﳎﻤﻮﻋﺔ‬‫ﻣﻦ‬٧‫ﻧﻘﺎط‬‫ﺑﻴﺎﻧﻴﺔ‬‫أو‬‫أﻛﺜﺮ‬‫ﻣﺘﺘﺎﻟﻴﺔ‬(
x
x
x
x
xx xx xx
Trend
= Gradual
x
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
+2s
Mean
-2s
+3s
+1s
-3s
-1s
+4s
-4s
+2s
Mean
-2s
+3s
+1s
-1s
+4s
-4s
-3s
x

35. ‫اﻟﻘﺎﻋﺪة‬‫اﳌﻔﺮدة‬)Single Rule(
‫ﺑﻨﻘﺼﺪ‬‫ﻟﻠﻤﺘﻮ‬‫اﳌﻌﻴﺎرﻳﺔ‬‫اﻻﳓﺮاﻓﺎت‬‫ﻣﻦ‬‫اﺛﻨﲔ‬‫ﻣﻨﻄﻘﺔ‬‫داﺧﻞ‬‫ﺗﻜﻮن‬‫ﻻزم‬‫اﻟﻜﻨﱰول‬‫ﻗﻴﻢ‬‫إن‬‫ﺑﻴﻬﺎ‬‫ﺳﻂ‬)±2s(
...‫دي‬‫اﳌﻨﻄﻘﺔ‬‫ﺧﺎرج‬‫اﻟﻜﻮﻧﱰول‬‫ﻗﻴﻢ‬‫ﻟﻮ‬......‫ﺣﺼﻞ‬‫ﺧﻄﺄ‬‫ﻓﻴﻪ‬‫ﻳﺒﻘﺎ‬
...‫ﻣﺎ‬‫ﺣﺪ‬‫إﱃ‬‫ﺻﺎرﻣﺔ‬‫اﳌﻔﺮدة‬‫اﻟﻘﺎﻋﺪة‬
...‫وأﻣﻮال‬‫وﻗﺖ‬‫وﺗﻬﺪر‬‫اﳌﻘﺒﻮﻟﺔ‬‫اﻟﺘﺸﻐﻴﻞ‬‫ﻋﻤﻠﻴﺎت‬‫رﻓﺾ‬‫إﱃ‬‫ﺗﺆدي‬‫ﻛﺎذﺑﺔ‬‫إﻧﺬارات‬‫إﱃ‬‫ﺗﺆدي‬‫وﳑﻜﻦ‬‫اﳌﻌﻤﻞ‬.
+2s
-2s
+3s
+1s
-3s
x
M
10987654321 20191817161514131211 RUN
-1s
x
x x
x x
+2s
-2s
x
x 95% 99.7%
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬

36. +2s
-2s
+3s
+1s
-3s
x
M
10987654321 20191817161514131211 RUN
-1s
x
x x
x x
+3s
-3s
x
x
،‫ﻟﻠﺸﻐﻞ‬‫اﳋﺎﻃﺊ‬‫اﻟﺮﻓﺾ‬‫ﻣﻌﺪل‬‫ﳋﻔﺾ‬
‫إﱃ‬ ‫داﺧﻠﻬﺎ‬‫اﻟﻜﻮﻧﱰول‬‫ﻗﻴﻢ‬‫ﺗﻜﻮن‬‫ﻻزم‬‫اﻟﻠﻲ‬‫اﳌﻨﻄﻘﺔ‬‫ﺣﺪود‬‫ﻧﻮﺳﻊ‬‫ﳑﻜﻦ‬)±3s(
...‫اﻷﺧﻄﺎء‬‫اﻛﺘﺸﺎف‬‫ﻣﻌﺪل‬‫ﻣﻦ‬‫اﻟﺘﻘﻠﻴﻞ‬‫إﱃ‬‫ﻳﺆدي‬‫ﳑﻜﻦ‬‫اﻟﺘﻮﺳﻴﻊ‬‫ﺑﺲ‬
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬

37. +2s
-2s
+3s
+1s
-3s
x
M
10987654321 20191817161514131211 RUN
-1s
x
x x
x x
x
x
،‫ﻟﻠﺸﻐﻞ‬‫اﳋﺎﻃﺊ‬‫اﻟﺮﻓﺾ‬‫ﻣﻌﺪل‬‫ﳋﻔﺾ‬
‫إﱃ‬ ‫داﺧﻠﻬﺎ‬‫اﻟﻜﻮﻧﱰول‬‫ﻗﻴﻢ‬‫ﺗﻜﻮن‬‫ﻻزم‬‫اﻟﻠﻲ‬‫اﳌﻨﻄﻘﺔ‬‫ﺣﺪود‬‫ﻧﻮﺳﻊ‬‫ﳑﻜﻦ‬)±3s(
...‫اﻷﺧﻄﺎء‬‫اﻛﺘﺸﺎف‬‫ﻣﻌﺪل‬‫ﻣﻦ‬‫اﻟﺘﻘﻠﻴﻞ‬‫إﱃ‬‫ﻳﺆدي‬‫ﳑﻜﻦ‬‫اﻟﺘﻮﺳﻴﻊ‬‫ﺑﺲ‬
...‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬‫أﻧﻈﻤﺔ‬‫إﱃ‬‫اﻟﺘﻄﻮﻳﺮ‬‫ﰎ‬‫ﻛﺪه‬‫ﻋﻠﺸﺎن‬...‫ﺎ‬ ‫ﹰ‬‫ﻣﺮﺗﻔﻌ‬‫اﻷﺧﻄﺎء‬‫اﻛﺘﺸﺎف‬‫ﻣﻌﺪل‬‫ﻋﻠﻰ‬‫ﻟﻠﺤﻔﺎظ‬
...‫ﺎ‬ ‫ﹰ‬‫ﻣﻨﺨﻔﻀ‬‫اﳋﺎﻃﺊ‬‫اﻟﺮﻓﺾ‬‫وﻣﻌﺪل‬
R4s Rule
QC Multi−rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬

38. +2s
-2s
+3s
+1s
-3s
x
M
10987654321 20191817161514131211 RUN
-1s
x
x x
x x
x
x
‫أن‬‫اﻹﻋﺘﺒﺎر‬‫ﰲ‬‫ﻧﻀﻊ‬‫وﻻزم‬
‫اﺳﺘﺨﺪام‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬‫اﳌ‬‫اﻟﻜﻨﱰوﻻت‬‫ﻋﺪد‬‫زاد‬‫ﻛﻠﻤﺎ‬‫اﻷﺧﻄﺎء‬‫أﻛﺘﺸﺎف‬‫ﰲ‬‫ﺎ‬ ‫ﹰ‬‫ﳒﺎﺣ‬‫أﻛﺜﺮ‬‫ﺗﻜﻮن‬‫ﺴﺘﺨﺪﻣﺔ‬
...‫ﻛﻨﱰوﻟﲔ‬‫اﺳﺘﺨﺪام‬)Control Level I & II(‫واﺣﺪ‬‫ﻣﻦ‬‫أﻓﻀﻞ‬
...‫اﺳﺘﺨﺪام‬٣‫ﻛﻮﻧﱰوﻻت‬)Control Level I , II & III(‫اﺗﻨﲔ‬‫ﻣﻦ‬‫أﻓﻀﻞ‬
22s Rule
R4s Rule
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬

39. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s
‫ﻋﻠﻰ‬‫ﺗﺘﻄﺒﻖ‬‫ﳑﻜﻦ‬‫ﻋﺎﻣﺔ‬‫ﺑﺼﻔﺔ‬‫اﻟﻘﻮاﻋﺪ‬‫واﺣﺪ‬‫ﻛﻮﻧﱰول‬...‫ﺑﻨﺴﻴﻤﻴﻬﺎ‬‫دي‬‫و‬across runs
...‫ال‬ ‫ﻣﻊ‬‫ﺑﻨﺪﺧﻠﻪ‬‫اﻟﻠﻲ‬‫اﻟﻜﻮﻧﱰول‬‫ﻗﺮاءات‬‫ﺑﲔ‬‫ﻣﺎ‬‫ﺑﻨﻘﺎرن‬‫ﻋﺸﺎن‬‫ﻛﻞ‬run
‫ﻛﻨﱰول‬‫ﻣﻦ‬‫أﻛﱰ‬...‫ﺑﻨﺴﻴﻤﻴﻬﺎ‬‫ودي‬within- run
...‫ﻛﻨﱰوﻟﲔ‬‫ﺑﲔ‬‫ﻣﺎ‬)Control Level I & II(‫ال‬‫ﻧﻔﺲ‬‫ﰲ‬run
...‫أو‬٣‫ﻛﻨﱰوﻻت‬)Control Level I , II & III(‫ال‬‫ﻧﻔﺲ‬‫ﰲ‬run
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬

40. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s
‫اﻟﻘﻮاﻋﺪ‬‫ﻫﺬه‬‫وﺿﻊ‬‫ﻣﻦ‬‫اﳍﺪف‬
...‫ﺎ‬ ‫ﹰ‬‫ﻣﺮﺗﻔﻌ‬‫اﻷﺧﻄﺎء‬‫اﻛﺘﺸﺎف‬‫ﻣﻌﺪل‬‫ﻋﻠﻰ‬‫اﳊﻔﺎظ‬IncreaseTheSensitivity of ErrorDetection
...‫ﺎ‬ ‫ﹰ‬‫ﻣﻨﺨﻔﻀ‬‫اﳋﺎﻃﺊ‬‫اﻟﺮﻓﺾ‬‫وﻣﻌﺪل‬Decrease Rate of false Rejection
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬

41. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s
‫ﻧﻮﻋﲔ‬‫اﻟﻘﻮاﻋﺪ‬:
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
‫ﻛﺴﺮ‬)‫إﻧﺘﻬﺎك‬(‫اﻟﻘﺎﻋﺪة‬....‫إﻧﺬار‬‫ﳎﺮد‬‫ﻫﻮ‬...‫ال‬‫ﻧﺘﺎﺋﺞ‬‫ﻧﻘﺒﻞ‬RUN...‫ال‬‫ﻣﻦ‬‫ﺑﺎﻟﻨﺎ‬‫ﳔﻠﻲ‬RUN‫اﳉﺎﻳﺔ‬‫اﳌﺮة‬
‫ﻛﺴﺮ‬)‫إﻧﺘﻬﺎك‬(‫اﻟﻘﺎﻋﺪة‬....‫اﻟﺸﻐﻞ‬‫إﻳﻘﺎف‬‫ﻣﻌﻨﺎه‬...‫ال‬‫ﻧﺘﺎﺋﺞ‬‫ﻧﺮﻓﺾ‬RUN...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫ﻧﺒﺤﺚ‬
‫ﻗﻮاﻋﺪ‬‫ﲢﺬﻳﺮﻳﺔ‬:Warning Rules
‫ﻗﻮاﻋﺪ‬‫إﺟﺒﺎرﻳﺔ‬:Violation Rules

42. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s
•‫ﻗﺎﻋﺪة‬‫ﻫﺬه‬‫ﲢﺬﻳﺮﻳﺔ‬–‫ﺣﺪود‬‫ﺧﺎرج‬‫اﻟﻜﻮﻧﱰول‬‫ﻗﻴﻤﺔ‬‫ﺗﻜﻮن‬‫ﻋﻨﺪﻣﺎ‬ ‫ﲢﺪث‬+/− 2S
•‫وﺟﻮد‬‫ﻣﻦ‬‫اﻟﻘﺎﻋﺪة‬‫ﻫﺬه‬‫ﲢﺬر‬Systematic or Random Error‫اﻻﺧﺘﺒﺎر‬‫ﻧﻈﺎم‬‫ﰲ‬
•‫إزاي‬‫ﻧﺘﺼﺮف‬:‫اﻓ‬‫ﻓﻴﺠﺐ‬،‫اﻻﺧﺘﺒﺎر‬‫ﻧﻈﺎم‬‫ﰲ‬‫أﺧﺮى‬‫ﻣﻘﺒﻮﻟﺔ‬‫ﻏﲑ‬‫ﻧﺘﺎﺋﺞ‬‫ﺗﻈﻬﺮ‬‫ﱂ‬‫إذا‬‫ده‬‫أن‬‫ﱰاض‬
‫ﳎﺮد‬‫ﻋﺸﻮاﺋﻲ‬‫ﺧﻄﺄ‬‫و‬‫ﻻ‬‫وإﺻﻼﺣﻬﺎ‬‫اﻷﺧﻄﺎء‬‫اﺳﺘﻜﺸﺎف‬‫ﻣﻦ‬‫ﻣﺰﻳﺪ‬‫إﺟﺮاء‬‫ﻳﻠﺰم‬.
x
x
x
Across runs
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
12s
‫ﻗﺎﻋﺪة‬
‫واﺣﺪة‬‫ﻗﺮاءة‬
‫ﺣﺪود‬‫ﺑﻬﺎ‬‫ﻳﻘﺼﺪ‬
‫ﻣﺮﺗﲔ‬‫ﻣﻌﻴﺎري‬‫اﳓﺮاف‬
‫اﳌﺘﻮﺳﻂ‬‫ﺧﻂ‬‫ﲢﺖ‬‫أو‬‫ﻓﻮق‬‫ﺳﻮاءا‬
1

43. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s
•‫اﻧﺘﻬﺎك‬‫ﺣﺪود‬‫ﺧﺎرج‬‫اﻟﻜﻮﻧﱰول‬‫ﻗﻴﻤﺔ‬‫ﺗﻜﻮن‬‫ﻋﻨﺪﻣﺎ‬ ‫ﳛﺪث‬‫اﻟﻘﺎﻋﺪة‬‫ﻫﺬه‬+/− 3S
•‫وﺟﻮد‬‫ﻋﻠﻰ‬‫ﺗﺪل‬Random Error‫ﻣﻘﺒﻮل‬‫ﻏﲑ‬...‫ل‬‫ﺑﺪاﻳﺔ‬‫أو‬Systematic Error‫ﻛﺒﲑ‬
•‫إزاي‬‫ﻧﺘﺼﺮف‬:‫ال‬‫رﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫واﻟﺒﺤﺚ‬.
x
x
x
Across runs
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
13s
‫ﻗﺎﻋﺪة‬
‫واﺣﺪة‬‫ﻗﺮاءة‬
‫ﺣﺪود‬‫ﺑﻬﺎ‬‫ﻳﻘﺼﺪ‬
‫ﻣﻌﻴﺎري‬‫اﳓﺮاف‬٣‫ﻣﺮات‬
‫اﳌﺘﻮﺳﻂ‬‫ﺧﻂ‬‫ﲢﺖ‬‫أو‬‫ﻓﻮق‬‫ﺳﻮاءا‬
2

44. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s x
x
x
Across runs
across-runs:‫اﻟﻜﻨﱰول‬‫ﻟﻨﻔﺲ‬‫ﻣﺘﺘﺎﻟﻴﺘﲔ‬‫ﻗﺮاءﺗﲔ‬–‫اﳉﺎﻧﺐ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬–‫ﻣﻨ‬ ‫ﺧﺎرج‬‫ال‬‫ﻄﻘﺔ‬2S
within-run:‫ﳐﺘﻠﻔﲔ‬‫ﻛﻨﱰوﻟﲔ‬‫ﻗﺮاءة‬–‫اﳉﺎﻧﺐ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬–‫ال‬‫ﻣﻨﻄﻘﺔ‬ ‫ﺧﺎرج‬2S
‫وﺟﻮد‬‫ﻋﻠﻰ‬‫ﻳﺪل‬‫وده‬Systematic Error...‫ﺑﺪاﻳﺔ‬‫إﱃ‬‫ﺗﺸﲑ‬‫أن‬‫وﳝﻜﻦ‬)Trend(‫أو‬)Shift(
‫إزاي‬‫ﻧﺘﺼﺮف‬:‫ال‬‫رﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫واﻟﺒﺤﺚ‬.
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
22s
‫ﻗﺎﻋﺪة‬
‫ﻗﺮاءﺗﲔ‬
‫ﺣﺪود‬‫ﺑﻬﺎ‬‫ﻳﻘﺼﺪ‬
‫ﻣﺮﺗﲔ‬‫ﻣﻌﻴﺎري‬‫اﳓﺮاف‬
‫اﳌﺘﻮﺳﻂ‬‫ﺧﻂ‬‫ﲢﺖ‬‫أو‬‫ﻓﻮق‬‫ﺳﻮاءا‬
3

45. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s x
x
x
Within-run
across-runs:‫اﻟﻜﻨﱰول‬‫ﻟﻨﻔﺲ‬‫ﻣﺘﺘﺎﻟﻴﺘﲔ‬‫ﻗﺮاءﺗﲔ‬–‫اﳉﺎﻧﺐ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬–‫ﻣﻨ‬ ‫ﺧﺎرج‬‫ال‬‫ﻄﻘﺔ‬2S
within-run:‫ﳐﺘﻠﻔﲔ‬‫ﻛﻨﱰوﻟﲔ‬‫ﻗﺮاءة‬–‫اﳉﺎﻧﺐ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬–‫ال‬‫ﻣﻨﻄﻘﺔ‬ ‫ﺧﺎرج‬2S
‫وﺟﻮد‬‫ﻋﻠﻰ‬‫ﻳﺪل‬‫وده‬Systematic Error...‫ﺑﺪاﻳﺔ‬‫إﱃ‬‫ﺗﺸﲑ‬‫أن‬‫وﳝﻜﻦ‬)Trend(‫أو‬)Shift(
‫إزاي‬‫ﻧﺘﺼﺮف‬:‫ال‬‫رﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫واﻟﺒﺤﺚ‬.
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
22s
‫ﻗﺎﻋﺪة‬
‫ﻗﺮاءﺗﲔ‬
‫ﺣﺪود‬‫ﺑﻬﺎ‬‫ﻳﻘﺼﺪ‬
‫ﻣﺮﺗﲔ‬‫ﻣﻌﻴﺎري‬‫اﳓﺮاف‬
‫اﳌﺘﻮﺳﻂ‬‫ﺧﻂ‬‫ﲢﺖ‬‫أو‬‫ﻓﻮق‬‫ﺳﻮاءا‬
3
xControl level 1
Control level 2

46. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s x
x
across-runs
4s‫واﺣﺪة‬‫ﺣﺘﺔ‬
‫اﻧﺘﻬﺎك‬‫ﻳﻜﻮن‬‫ﻋﻨﺪﻣﺎ‬‫اﻟﻘﺎﻋﺪة‬:
across-runs:‫ﻫﻮ‬‫اﻟﻜﻨﱰول‬‫ﻟﻨﻔﺲ‬‫ﻣﺘﺘﺎﻟﻴﺘﲔ‬‫ﻗﺮاءﺗﲔ‬‫ﺑﲔ‬‫اﻟﻔﺮق‬4S
within-run:‫ﻫﻮ‬‫ﳐﺘﻠﻔﲔ‬‫ﻛﻨﱰوﻟﲔ‬‫ﻗﺮاءة‬‫ﺑﲔ‬‫اﻟﻔﺮق‬4S
‫ﻋﻠﻰ‬‫ﻳﺪل‬‫وده‬Systematic Error...‫ال‬‫ﻧﺮﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫وﻧﺒﺤﺚ‬.
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
R4s
‫ﻗﺎﻋﺪة‬
‫ﻗﺮاءﺗﲔ‬
‫ﺣﺪود‬‫ﺑﻬﺎ‬‫ﻳﻘﺼﺪ‬
‫ﻣﻌﻴﺎري‬‫اﳓﺮاف‬٤‫ﻣﺮات‬
‫اﳌﺘﻮ‬‫ﺧﻂ‬‫ﲢﺖ‬‫اﺗﻨﲔ‬‫و‬‫ﻓﻮق‬‫اﺗﻨﲔ‬‫ﺳﻂ‬
4

47. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s x
x
x
Within-run
4s‫واﺣﺪة‬‫ﺣﺘﺔ‬
‫اﻧﺘﻬﺎك‬‫ﻳﻜﻮن‬‫ﻋﻨﺪﻣﺎ‬‫اﻟﻘﺎﻋﺪة‬:
across-runs:‫ﻫﻮ‬‫اﻟﻜﻨﱰول‬‫ﻟﻨﻔﺲ‬‫ﻣﺘﺘﺎﻟﻴﺘﲔ‬‫ﻗﺮاءﺗﲔ‬‫ﺑﲔ‬‫اﻟﻔﺮق‬4S
within-run:‫ﻫﻮ‬‫ﳐﺘﻠﻔﲔ‬‫ﻛﻨﱰوﻟﲔ‬‫ﻗﺮاءة‬‫ﺑﲔ‬‫اﻟﻔﺮق‬4S
‫ﻋﻠﻰ‬‫ﻳﺪل‬‫وده‬Systematic Error...‫ال‬‫ﻧﺮﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫وﻧﺒﺤﺚ‬.
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
R4s
‫ﻗﺎﻋﺪة‬
‫ﻗﺮاءﺗﲔ‬
‫ﺣﺪود‬‫ﺑﻬﺎ‬‫ﻳﻘﺼﺪ‬
‫ﻣﻌﻴﺎري‬‫اﳓﺮاف‬٤‫ﻣﺮات‬
‫اﳌﺘﻮ‬‫ﺧﻂ‬‫ﲢﺖ‬‫اﺗﻨﲔ‬‫و‬‫ﻓﻮق‬‫اﺗﻨﲔ‬‫ﺳﻂ‬
4
xControl level 1
Control level 2

48. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s x
x
across-runs
x
‫اﻧﺘﻬﺎك‬‫ﻳﻜﻮن‬‫ﻋﻨﺪﻣﺎ‬‫اﻟﻘﺎﻋﺪة‬:
across-runs:٤‫ﻣﺘﺘﺎﻟﻴﺔ‬‫ﻗﺮاءات‬–‫ﻣﻦ‬ ‫أﻛﱪ‬1S–‫ال‬‫ﻣﻦ‬‫اﳉﺎﻧﺐ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬mean
within-run:‫ﺘﻠﻔﲔ‬‫ا‬‫اﻟﻜﻨﱰوﻟﲔ‬‫ﻣﻦ‬‫ﻟﻜﻞ‬‫ﻣﺘﺘﺎﻟﻴﺘﲔ‬‫ﻗﺮاءاﺗﲔ‬–‫أﻛﱪ‬‫ﻣﻦ‬1S
‫ﻋﻠﻰ‬‫ﻳﺪل‬‫وده‬Systematic Error...‫ال‬‫ﻧﺮﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫وﻧﺒﺤﺚ‬.
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
41s
‫ﻗﺎﻋﺪة‬
‫ﺣﺪود‬‫ﺑﻬﺎ‬‫ﻳﻘﺼﺪ‬
‫واﺣﺪة‬‫ﻣﺮة‬‫ﻣﻌﻴﺎري‬‫اﳓﺮاف‬
5

49. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s x
x
x
Within-run
‫اﻧﺘﻬﺎك‬‫ﻳﻜﻮن‬‫ﻋﻨﺪﻣﺎ‬‫اﻟﻘﺎﻋﺪة‬:
across-runs:٤‫ﻣﺘﺘﺎﻟﻴﺔ‬‫ﻗﺮاءات‬–‫ﻣﻦ‬ ‫أﻛﱪ‬1S–‫ال‬‫ﻣﻦ‬‫اﳉﺎﻧﺐ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬mean
within-run:‫ﺘﻠﻔﲔ‬‫ا‬‫اﻟﻜﻨﱰوﻟﲔ‬‫ﻣﻦ‬‫ﻟﻜﻞ‬‫ﻣﺘﺘﺎﻟﻴﺘﲔ‬‫ﻗﺮاءاﺗﲔ‬–‫أﻛﱪ‬‫ﻣﻦ‬1S
‫ﻋﻠﻰ‬‫ﻳﺪل‬‫وده‬Systematic Error...‫ال‬‫ﻧﺮﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫وﻧﺒﺤﺚ‬.
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
41s
‫ﻗﺎﻋﺪة‬
‫ﺣﺪود‬‫ﺑﻬﺎ‬‫ﻳﻘﺼﺪ‬
‫واﺣﺪة‬‫ﻣﺮة‬‫ﻣﻌﻴﺎري‬‫اﳓﺮاف‬
5
xControl level 1
Control level 2

50. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s x
x
across-runs
x
‫اﻧﺘﻬﺎك‬‫ﻳﻜﻮن‬‫ﻋﻨﺪﻣﺎ‬‫اﻟﻘﺎﻋﺪة‬:
across-runs:١٠‫اﻟﻜﻨﱰول‬‫ﻟﻨﻔﺲ‬‫ﻣﺘﺘﺎﻟﻴﺔ‬‫ﻗﺮاءات‬–‫ال‬‫ﻣﻦ‬‫اﻟﻨﺎﺣﻴﺔ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬mean
within-run:٥‫ﺘﻠﻔﲔ‬‫ا‬‫اﻟﻜﻨﱰوﻟﲔ‬‫ﻣﻦ‬‫ﻟﻜﻞ‬‫ﻣﺘﺘﺎﻟﻴﺔ‬‫ﻗﺮاءات‬–‫اﻟﻨﺎﺣﻴ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬‫ال‬‫ﻣﻦ‬‫ﺔ‬mean
‫ﻋﻠﻰ‬‫ﻳﺪل‬‫وده‬Systematic Error...‫ال‬‫ﻧﺮﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫وﻧﺒﺤﺚ‬.
x
x x
x
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
‫ﻗﺎﻋﺪة‬
6
10x

51. +2s
-2s
+3s
+1s
-3s
M
10987654321 20191817161514131211 RUN
-1s x
x
x
Within-run
xControl level 1
Control level 2
‫اﻧﺘﻬﺎك‬‫ﻳﻜﻮن‬‫ﻋﻨﺪﻣﺎ‬‫اﻟﻘﺎﻋﺪة‬:
across-runs:١٠‫اﻟﻜﻨﱰول‬‫ﻟﻨﻔﺲ‬‫ﻣﺘﺘﺎﻟﻴﺔ‬‫ﻗﺮاءات‬–‫ال‬‫ﻣﻦ‬‫اﻟﻨﺎﺣﻴﺔ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬mean
within-run:٥‫ﺘﻠﻔﲔ‬‫ا‬‫اﻟﻜﻨﱰوﻟﲔ‬‫ﻣﻦ‬‫ﻟﻜﻞ‬‫ﻣﺘﺘﺎﻟﻴﺔ‬‫ﻗﺮاءات‬–‫اﻟﻨﺎﺣﻴ‬‫ﻧﻔﺲ‬‫ﻋﻠﻰ‬‫ال‬‫ﻣﻦ‬‫ﺔ‬mean
‫ﻋﻠﻰ‬‫ﻳﺪل‬‫وده‬Systematic Error...‫ال‬‫ﻧﺮﻓﺾ‬Run...‫اﳌﺸﻜﻠﺔ‬‫ﺳﺒﺐ‬‫ﰲ‬‫وﻧﺒﺤﺚ‬.
‫ﺟﺎرد‬‫وﻳﺴﺖ‬‫ل‬‫اﳌﺘﻌﺪدة‬‫اﻟﻘﻮاﻋﺪ‬Westgard QC Multi-rules
‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
‫ﻗﺎﻋﺪة‬
6
10x

52. ‫ﳐﻄﻄﺎت‬‫راﺟﻊ‬Levey-Jennings‫ﻛﻮﻳﺲ‬
‫ﺗﻔﻬﻢ‬‫ﻋﻠﺸﺎن‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﺣﺼﻞ‬‫اﻟﺬي‬
‫ﺛﺎﻧﻴﺎ‬
‫ﻗﻮاﻋﺪ‬‫ﻧﻄﺒﻖ‬‫إزاي‬Westgard
‫ﲢﺬﻳﺮ‬12s
‫ﲢﺬﻳﺮ‬‫ﻓﻴﻪ‬‫أﻳﻮه‬
‫ﻣﻔﻴﺶ‬
‫ال‬‫إﻗﺒﻞ‬RUN
‫ﻫﻞ‬
‫ﻟﻠﻘﺎﻋﺪة‬13s
‫ﻛﺴﺮ‬‫ﻓﻴﻪ‬
‫اﻳﻮه‬
‫ال‬‫ارﻓﺾ‬RUN
‫ﻷ‬
‫ﻫﻞ‬
‫ﻟﻠﻘﺎﻋﺪة‬22s
‫ﻛﺴﺮ‬‫ﻓﻴﻪ‬
Random error
‫ﻫﻞ‬
‫ﻟﻠﻘﺎﻋﺪة‬R4s
‫ﻛﺴﺮ‬‫ﻓﻴﻪ‬
‫ﻫﻞ‬
‫ﻟﻠﻘﺎﻋﺪة‬41s
‫ﻛﺴﺮ‬‫ﻓﻴﻪ‬
‫ﻫﻞ‬
‫ﻟﻠﻘﺎﻋــــﺪة‬10X
‫ﻛﺴﺮ‬‫ﻓﻴﻪ‬‫ﻷ‬ ‫ﻷ‬ ‫ﻷ‬
‫ﻣﻔﻴﺶ‬‫ﻷ‬
‫اﻳﻮه‬
‫ال‬‫ارﻓﺾ‬RUN
Systematic error
‫اﻳﻮه‬
‫ال‬‫ارﻓﺾ‬RUN
Random error
‫اﻳﻮه‬
‫ال‬‫ارﻓﺾ‬RUN
Systematic error
‫اﻳﻮه‬
‫ال‬‫ارﻓﺾ‬RUN
Systematic error‫ﻏﺎﻟﺒﺎ‬
‫ﻓﻴﻪ‬‫ﻫﻞ‬
‫إﺑﺪأ‬

53. Multirules for 3 Controls

54. 3
Relate
the type of error to possible causes
‫ارﺑﻂ‬‫اﳋﻄﺄ‬‫ﻧﻮع‬‫ﻟﻴﻪ‬‫اﶈﺘﻤﻠﺔ‬‫ﺑﺎﻷﺳﺒﺎب‬ ‫اﻟﺘﺼﺤﻴﺤﻴﺔ‬‫اﻹﺟﺮاءات‬‫ﺗﻨﻔﻴﺬ‬
...‫ﻓﺎﻋﻠﻴﺘﻬﺎ‬‫واﻟﺘﺤﻘﻖ‬
...‫اﳊﻞ‬‫ﺗﻮﺛﻴﻖ‬‫و‬
Implement corrective actions
Check their effectiveness
Document the solution
4
‫ﺛﺎﻟﺜﺎ‬ ‫راﺑﻌﺎ‬

55. Possible CauseError Corrective Action
Systematic
(Sudden shift)
Temperature Changes
Change in calibration lot
New reagent lot
Light source Change or Failure
Maintenance
Sampling system failure
Reagent
Change in reagent formulation
Calibration Recent calibration
Major instrument maintenance
Fix
Fix
Fix
Do Maintenance
It’s OK
It’s OK
xx x x
xx x

56. Possible CauseError Corrective Action
Systematic
(Gradual Trend)
Temperature Gradual change
Light source Slowly deteriorating
Reagent Slowly deteriorating
Calibration Gradual Shift
Fix
Fix
Fix
Change
xx x x x
x
x
x
Control Slowly deteriorating
Filters Slowly deteriorating
Change
Change

57. Possible CauseError Corrective Action
Random
Power Supply Fluctuations Fix power supply
Remove Clog
Ensure No bubbles
xx x x
x
Control Improper mixing
Improper dissolving
Pipetting Clog
Ensure No bubbles
Proper mixing
Proper dissolving
x x
Sample Bubbles
Reagent Bubbles
Improper mixing
Improper dissolving
Proper mixing
Proper dissolving

58. ‫ﺑﺎﻟﱰﺗﻴﺐ؟‬‫ﻧﺘﺒﻌﻬﺎ‬‫ﳑﻜﻦ‬‫اﻟﻠﻲ‬‫اﳋﻄﻮات‬‫ﻫﻴﺎ‬‫إﻳﻪ‬‫ﻃﻴﺐ‬
|‫اﻟﻜﻨﱰول‬‫إن‬‫ﻧﺘﺄﻛﺪ‬Level‫ﺻﺢ‬–)‫ﻣﻊ‬‫ﻣﻄﻠﻐﺒﻄﻨﺎش‬Level‫ﺗﺎﱐ‬(
|‫اﻟﻜﻮﻧﱰول‬‫ﺻﻼﺣﻴﺔ‬‫ﺗﺎرﻳﺦ‬‫ﻣﻦ‬‫ﻧﺘﺄﻛﺪ‬
|‫ﺑﺪري‬‫ﻣﻦ‬‫ﻣﺘﺤﻀﺮ‬‫اﻟﻜﻮﻧﱰول‬‫ﻫﻞ‬–)‫ﺑﺎظ‬‫و‬‫اﻟﺘﺎرﻳﺦ‬‫ﻋﺪى‬‫ﻳﻜﻮن‬‫ﳑﻜﻦ‬(
|‫ﺻﺢ‬‫ﺑﻄﺮﻳﻘﺔ‬‫ﻣﺘﺨﺰن‬‫اﻟﻜﻨﱰول‬)‫اﻟﺜﻼﺟﺔ‬(
|‫ﻷ‬‫وﻻ‬‫ﻛﻮﻳﺲ‬‫ﻣﺘﺤﻀﺮ‬–‫ﻳﻜﻮن‬‫ﳑﻜﻦ‬mixing‫اﻟﺘﺤﻀﲑ‬‫أﺛﻨﺎء‬‫ﻣﻀﺒﻮط‬‫ﻣﺶ‬
|‫ﻣﻔﻬﺎش‬‫ﺳﻠﻴﻤﺔ‬‫أﻧﻬﺎ‬‫ﻧﺘﺄﻛﺪ‬‫ﻋﻴﻨﺔ‬‫ﻟﻮﻛﺎن‬‫اﻟﻜﻨﱰول‬Hemolysis
‫اﻟﺘﺼﺤﻴﺤﻲ‬‫اﻹﺟﺮاء‬:–‫ﻓﺎﻳﻞ‬ ‫ﳓﻀﺮ‬Vial‫ﺳﻠﻴﻤﺔ‬‫ﺑﻄﺮﻳﻘﺔ‬‫ﺟﺪﻳﺪ‬‫ﻛﻨﱰول‬
–‫ﻛﻨﱰول‬‫اﺳﺘﺨﺪام‬‫ﻋﻠﻰ‬‫رﺳﻴﺖ‬‫وﻟﻮ‬Lot‫ﺟﺪﻳﺪ‬...‫ﻧﺴﺘﺨﺪﻣﻪ‬
|‫ﺗﺎﱐ‬‫ﺧﺎﺻﺔﺑﺈﺧﺘﺒﺎر‬‫دي‬‫وﻻ‬ ‫ده‬‫ﻟﻺﺧﺘﺒﺎر‬‫ﻓﻌﻼ‬‫ﺑﻨﺴﺘﺨﺪﻣﻬﺎ‬‫اﻟﻠﻲ‬‫ﻫﻴﺎ‬‫اﶈﺎﻟﻴﻞ‬
|‫ال‬‫ﺑﺮﻗﻢ‬‫ﻫﻲ‬‫ﻫﻞ‬Lot‫ﺑﺎﻟﻨﺎ‬‫واﺧﺪﻳﻦ‬‫ﻣﺶ‬‫واﺣﻨﺎ‬...‫ال‬‫ﺗﻐﻴﲑ‬‫ﻓﻴﻪ‬‫ﻟﻮ‬Lot‫ﺗﻌﻤﻞ‬‫ﻻزم‬‫ﻳﺒﻘﺎ‬calibration‫ﺟﺪﻳﺪ‬
|‫اﶈﺎﻟﻴﻞ‬‫ﺻﻼﺣﻴﺔ‬‫ﺗﺎرﻳﺦ‬‫ﻣﻦ‬‫اﻟﺘﺄﻛﺪ‬
|‫ﺳﻠﻴﻤﺔ‬‫ﺑﺼﻮرة‬‫اﶈﺎﻟﻴﻞ‬‫ﲣﺰﻳﻦ‬‫ﻣﻦ‬‫اﻟﺘﺄﻛﺪ‬–‫ﺑﺮه‬‫إﺗﺴﺎﺑﺖ‬‫اﶈﺎﻟﻴﻞ‬‫أو‬‫ﻃﻮﻳﻠﺔ‬‫ﻓﱰة‬‫اﻟﺘﻼﺟﺔ‬‫ﻋﻦ‬‫اﻟﻜﻬﺮﺑﺎ‬‫اﺗﻘﻄﻌﺘﺶ‬‫ﻣﺎ‬
|‫ﺑﺘﺘﺤﻀﺮ‬‫اﶈﺎﻟﻴﻞ‬‫ﻟﻮ‬...‫ﻣﻀﺒﻮط‬‫اﲢﻀﺮت‬‫إﻧﻬﺎ‬‫ﻧﺘﺄﻛﺪ‬‫ﻻزم‬‫ﻳﺒﻘﺎ‬
)‫ال‬Pipette‫ﻣﻀﺒﻮﻃﺔ؟‬‫ﺑﻴﻬﺎ‬‫ﺑﻨﺤﻀﺮ‬‫اﻟﻠﻲ‬–‫ﻣﻀﺒﻮﻃﺔ؟‬ ‫اﻟﻜﻤﻴﺎت‬–‫ال‬mixing‫ﻣﻀﺒﻮط؟‬(
|‫ال‬‫ﻗﺮاءة‬‫إن‬‫ﻧﺘﺄﻛﺪ‬Background‫ﺑﻴﻪ‬‫اﳌﺴﻤﻮح‬‫ﰲ‬‫اﶈﺎﻟﻴﻞ‬‫ﺑﺘﺎﻋﺔ‬)‫ﻣﺘﻐﲑ‬‫ﻟﻮﻧﻪ‬‫أو‬‫ﻣﻠﻮن‬‫ﻣﺶ‬‫اﻟﺒﻼﻧﻚ‬(
‫اﻟﺘﺼﺤﻴﺤﻲ‬‫اﻹﺟﺮاء‬:–‫ﻓﺎﻳﻞ‬ ‫ﻧﻔﺘﺢ‬Reagent Vial‫اﻟﻜﻮﻧﱰول‬‫ﻋﻠﻴﻪ‬‫ﻧﺪﺧﻞ‬‫و‬‫ﺟﺪﻳﺪ‬
–‫اﺳﺘﺨﺪام‬‫ﻋﻠﻰ‬‫رﺳﻴﺖ‬‫وﻟﻮ‬Reagent Lot‫ﺟﺪﻳﺪ‬...‫ﻧﺴﺘﺨﺪﻣﻪ‬
Controls
1
2
‫اﻟﻜﻨﱰوﻻت‬
‫اﶈﺎﻟﻴﻞ‬)‫اﻟﻜﻮاﺷﻒ‬(
Reagents
Checklist
Controls

59. |‫ﻓﻴﻬﺎ‬‫ﻋﻤﻠﻨﺎ‬‫ﻣﺮة‬‫آﺧﺮ‬‫ﺗﺎرﻳﺦ‬‫ﻋﻠﻰ‬‫ﻧﺒﺺ‬Calibration
|‫ال‬‫ﺗﻐﻴﲑ‬‫ﻳﺘﻢ‬‫ﱂ‬‫أﻧﻪ‬‫ﻣﻦ‬‫ﻧﺘﺄﻛﺪ‬Calibration factors‫اﳉﻬﺎز‬‫ﻋﻞ‬
|‫ال‬‫ﻧﺘﺄﻛﺪﻣﻦ‬Lot–‫اﻟﺘﺨﺰﻳﻦ‬‫ﻣﻦ‬–‫اﻟﺘﺤﻀﲑ‬‫ﻣﻦ‬–‫اﻟﺼﻼﺣﻴﺔ‬‫ﺗﺎرﻳﺦ‬‫ﻣﻦ‬
‫اﻟﺘﺼﺤﻴﺤﻲ‬‫اﻹﺟﺮاء‬:–‫ال‬‫إﻋﺎدة‬Calibration
3
4
|‫ﻛﻜﻞ‬‫اﳌﻌﻤﻞ‬‫أو‬ ‫اﳉﻬﺎز‬‫ﺣﺮارة‬‫درﺟﺔ‬‫ﻓﺤﺺ‬
|‫ﺑﺎﳌﻜﺎن‬‫اﻟﺮﻃﻮﺑﺔ‬‫ﻧﺴﺒﺔ‬‫ارﺗﻔﺎع‬
|‫ﺗﺘﻨﻀﻒ‬‫ﻋﺎﻳﺰة‬‫اﳉﻬﺎز‬‫ﻣﻦ‬‫أﺟﺰاء‬
|‫ﻣﺘﻌﻤﻠﺘﺶ‬‫ﺻﻴﺎﻧﺔ‬‫ﻋﻤﻞ‬‫ﳏﺘﺎج‬‫اﳉﻬﺎز‬
|‫ﻗﺮﻳﺒﺔ‬‫ﻓﱰة‬‫ﻣﻦ‬‫اﳉﻬﺎز‬‫ﻣﻦ‬‫ﺟﺰء‬‫ﺗﻐﲑ‬‫ﻋﻦ‬‫اﻟﺴﺆال‬
|‫اﳉﻬﺎز‬‫ﻧﻔﺤﺺ‬‫ﺗﺎﻟﻒ‬‫ﺟﺰء‬‫أو‬‫ﻣﻔﺼﻮل‬‫ﺟﺰء‬‫أو‬‫ﺗﺴﺮﻳﺐ‬‫ﰲ‬‫ﻧﺸﻮف‬
5
‫اﳌﻌﺎﻳﺮة‬
Calibration
‫اﳍﺎردوﻳﺮ‬
‫اﳌﻨﻄﻘﺔ‬
‫اﶈﻴﻄﺔ‬
Hardware
Environment
Checklist ‫ﺑﺎﻟﱰﺗﻴﺐ؟‬‫ﻧﺘﺒﻌﻬﺎ‬‫ﳑﻜﻦ‬‫اﻟﻠﻲ‬‫اﳋﻄﻮات‬‫ﻫﻴﺎ‬‫إﻳﻪ‬‫ﻃﻴﺐ‬

60. ‫ﻟﺴـــﻪ‬ ‫ﻟﻮ‬‫ﻣﺒﺘﺪيء‬‫ﺷﻐ‬‫ﰲ‬‫ﻞ‬
‫اﻟﻔﻮﻟﺪر‬‫أوي‬‫ﻫﻴﻔﻴﺪك‬‫ده‬
‫اﳌﺎﻳﻜﺮوﺑﻴﻮﻟﻮﺟﻲ‬

61. Results are outside
performance limits
The Complete Quality Control (QC) Process
Run
QC Samples (Controls)
Check that
The control values are acceptable
(within pre-established performance limits)
Run Patient Samples
Resolve
Troubleshooting
Acceptable Results
Repeat process
again