Professional Documents
Culture Documents
Prepared by
Precision Consultants, Inc.
2000 by
b Precision
P i i Consultants,
C lt t Inc.
I All rights
i ht reserved.
d Reproduction
R d ti in i partt or in
i whole
h l without
ith t written
itt permission
i i is i strictly
t i tl prohibited.
hibit d
Precision Consultants, Inc. is a registered name.
Optimize current OOS and OOT Investigation
Procedures
OOS—Out-of-Specification
OOT—Out-of-Trend
2
Judge
g Wolin’s Rulingg
4
Judge
g Wolin’s Rulingg
Averaging
A i - in
i certain
t i situations-
it ti
can provide a truer picture of reality,
but when used inappropriately
inappropriately, can
hide important variations.
5
Judge
g Wolin’s Rulingg
Resampling
Should rarely occur! Will occur when
the original sample was not truly
representative of the batch or there was a
documented/traceable lab error in its
preparation. Sound scientific
justification must be employed if re-
sampling is to occur.
6
Failure Investigations
DOCUMENTATION OF OOS
• Phase
ase I:: Who,
W o, How
ow (Lab)
( ab)
7
Fail re Investigations
Failure In estigations
PHASE II - FORMAL INVESTIGATION
8
Fail re Investigations
Failure In estigations
• Incorrect standard
• Calculation error
• Instrument malfunction
9
Fail re Investigations
Failure In estigations
10
Fail re Investigations
Failure In estigations
PHASE 1-LABORATORY INVESTIGATION OR
INFORMAL INVESTIGATION
11
Fail re Investigations
Failure In estigations
An OOS may be invalidated via explanation an/or retesting.
Always
y begin
g byy eliminatingg the followingg possible
p errors:
• Operator
• Laboratory/Analyst
• Process
• Method
• Non process
Non-process
12
Fail re Investigations
Failure In estigations
• Define Failure
13
Fail re Investigations
Failure In estigations
• Revisit
i i pilot
il batch
b h data.
d Design
i off experiment
i
14
Fail re Investigations
Failure In estigations
THE SOP:
• O
Out-of-Specification
t f S ifi ti SOP should h ld contain
t i
directions on handling and properly disposing
of an OOS laboratory or QC test results.
results
15
Fail re Investigations
Failure In estigations
16
Investigation of Out-of-Specification
Laboratory Test Results – General
17
What Do Yo
You In
Investigate?
estigate?
• Clerical Error:
– An error that can be attributed to an incorrect
calculation or transcription error
• Determinate
i Error:
– A known or identifiable error
• Indeterminate Error:
– An error that cannot be identified
19
T pes of Errors
Types
• Laboratory Error:
– An error that occurs in the process of testing, which
can be ascribed to an analyst error
error, an equipment
error or an unplanned test interruption
23
OOS In
Investigation
estigation Will Include
Incl de
24
What May Be Included in the OOS
I
Investigation
ti ti
• Confirm,, if applicable,
pp , all negative
g controls for
media, diluents, and test equipment were negative
25
What May
y Be Included in the OOS
Investigation
27
Repeat Testing
28
Investigation of OOS Microbiology
T tR
Test Results
lt
• The
h ffollowing
ll i describes
d ib suggestedd procedures
d to be
b
followed for resolution of out-of-specification microbiology
test results. The same ppractices mayy be utilized,, but is not
mandatory to investigate out-of-trend microbiology test
results
31
Investigation
g of OOS Microbiology
gy Test
Results
32
Reporting / Documentation of OOS or
Atypical Results
• All
ll results
l must be
b retained
i d in
i laboratory
l b records.
d Iff data
d isi
rejected, a complete description of the reason for rejection
must be included in the analyst’s
y records with the signatures
g
of both analyst and supervisor
• An
A analysis
l i off all
ll data
d derived
d i d from
f the
h testing
i
• A
An analysis
l i off any supporting
ti data
d t from
f other
th
tests performed
34
OOS Report Incl
Includes
des
35