This document discusses out of specification (OOS) and out of trend (OOT) results in pharmaceutical manufacturing. It defines OOS as test results that fall outside specified limits in product specifications. OOT refers to results that fall outside a statistical prediction or fail process control criteria. The frequent occurrence of OOS and OOT indicates issues with manufacturing and analytical procedures. This can result in market complaints, batch rejections, and inventory losses. Root cause analysis tools like 5Why, fishbone diagrams, and fault tree analysis should be used to investigate OOS results and address the underlying causes in order to prevent future occurrences. Corrective and preventive actions then need to be implemented and their impact assessed.

1. PREPARED BY:
Neeraj Kumar Rai
AGM-Manufacturing

2. The term OOS (out of specification), is
defined as those results of in process
or finished product testing, which
falling out of specified limits, that are
mentioned in specification.

3. A time dependent result which
falls outside a prediction
interval or fails a statistical
process control criterion.
How is OOT limit declared??

4. The frequent occurrence of OOS
and OOT results indicates that
the manufacturing and
analytical procedures not in
control.

5. The consequences of OOS may result in
market complaints, and rejection of
commercial batches, which is an inventory
loss for any pharmaceutical industry. So, the
OOS result occurrences have to be
investigated and addressed.
Occurrence of OOT indicates that there is
possibilities of occurrence of OOS, if not
controlled.

9.  Why-Why analysis
 5W-1H(What,Who,where,When,Why,How)
 Fishbone analysis (Ishikawa analysis) etc.
 Fault tree analysis

10.  By asking why why 5 times you can find the
root cause.

11.  By using this tool you can get entire detail of
any abnormality along with its root cause.

12.  Fishbone diagram or Ishikawa diagram is a
modern quality management tool that
explains the cause and effect relationship for
any quality issue that has arisen or that may
arise. It provides the visual representation of
all the possible causes for a problem to
analyze and find out the root cause. It is a
tool that can be used both proactively and
reactively.

13.  How to Create a Fishbone diagram?
 Make the head of the fish on the right. Here we mention the subject that needs our
attention.
 Draw a backbone on the left.
 Draw branches to the backbones that will list the main causes. List four to eight
main causes.
 Under these main causes are listed the causes and sub-causes. These can be
identified by organizing a brainstorming session or minutely following the whole
process and identifying all the possible reasons that can lead to quality damage.
 Identification of Factors Causing a Defect
 For the identification of factors, we may consider breaking all the reasons under the
following main-causes:
 Machine
 Materials
 Methods
 Personnel (Men)
 Measurements
 Environment(Mother nature)

14. Impact assessment
&
CAPA

15.  Correction: Action to eliminate a detected
nonconformity
 Corrective action: Action taken on the root
cause to prevent recurrence is known as
corrective action.
 Preventive action: Action taken on the
potential causes to prevent the occurrence is
called preventive action.

16. Any Question??

17. Thank You….