Name: Deviation Procedure Revision: [INSERT REV]

Document ID: XXXX Date Written: [INSERT DATE]

Insert Company Name

Deviation Procedure

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Name: Deviation Procedure Revision: [INSERT REV]
Document ID: XXXX Date Written: [INSERT DATE]

1. Purpose

The purpose of this document is to describe the investigation and control procedure for any type
of deviation, which can affect the quality of the product, to enable a suitable and prompt
corrective action.
2. Scope

This procedure is applicable to planned and unplanned deviations that occur within GMP-related
activities, procedures, processes, systems and operations that support manufacturing, testing,
packaging, labeling, storage and shipping of regulated products at [Insert Company Name]. This also
covers malfunctions or breakdown of equipment, instruments, or systems, out of calibration
events (OOCs) for equipment currently in use in production, and unplanned maintenance or repair
to facilities, utilities, equipment or systems including IT software and hardware that affect either
directly or indirectly the Quality System. Validation deviations are also covered under this
procedure.
3. REFERENCES

Reference Name or Title Document ID

4. ABBREVIATIONS AND DEFINITIONS

Term Definition

5. RESPONSIBILITIES

Role Reponsibilites

6. PROCEDURE
6.1 Deviations are Classified as Either Planned or Unplanned
6.1.1 Planned deviations are carried out for:
6.1.1.1 Quality improvement
6.1.1.2 Yield improvement
6.1.1.3 Safety reasons
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Name: Deviation Procedure Revision: [INSERT REV]
Document ID: XXXX Date Written: [INSERT DATE]

6.1.1.4 Break downs

6.1.1.5 Better GMPs
6.1.1.6 Market requirement
6.1.1.7 Insufficient inputs
6.1.2 Unplanned deviations can arise due to
6.1.2.1 Human error
6.1.2.2 Malfunctioning of any equipment or instrument
6.1.2.3 Equipment or instrument breakdown
6.1.2.4 Utility or service failure/breakdown
6.1.2.5 Yield deviation
6.2 Planned Deviation
6.2.1 The Initiator will schedule a meeting prior to implementing the deviation. The
meeting will include Quality, the customer (if applicable), and the appropriate
departments that are affected by the deviation.
6.2.2 The initiator will request a Planned Deviation Report form from Quality.
6.2.3 Quality will assign a Deviation number, forward the Planned Deviation Report
form to the initiator and work with the initiator to insure that the appropriate
departments are represented to review the Planned Deviation Report form.
6.2.4 Prior to the meeting, the Initiator will fill out the information about the planned
deviation to be presented.
6.2.5 During the meeting, the planned deviation is finalized and documented. This will
include the details of the deviation, associated documents, equipment and the
justification of the change.
6.2.6 A risk assessment will be performed to insure that the change is evaluated on the
impact to product, personnel, equipment and environment.
6.2.7 Quality will review the deviation, recommend any changes, if necessary and
ensures that proper action has been taken to prevent the recurrence of the need
for the same deviation.
6.2.8 Quality will upload the approved Planned Deviaton Report form into the tracking
database and routed for approval to close.
6.2.9 The Initiator, Quality and Engineer will approve the closure of the deviation in the
trackin database.

6.3 Unplanned Deviation

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Name: Deviation Procedure Revision: [INSERT REV]
Document ID: XXXX Date Written: [INSERT DATE]

6.3.1 Once a deviation is identified, it is the responsibility of the employee to notify the
area management, Engineering and Quality.
6.3.2 QA assigns a deviation number via the deviation tracking database. Deviation
numbers are autogenerated.
6.3.3 Quality forwards the form to the Initiator responsible for completing the
deviation.
6.3.4 The Initiator will fill out the form including the investigation. They will put
together a team including Quality to assist in the investigation.
6.3.5 Release or Rejection of lots will be based on the outcome of the investigation.
6.3.6 Any information that may need to be communicated to the Customer will be
done and the documentation for this including any approvals will be uploaded as
supporting evidence to the deviation.
6.3.7 The completed form and any other supporting documentation are returned to
Quality.
6.3.8 Quality will review the deviation and recommend any changes, if necessary.
6.3.9 The approved Unplanned Deviaton Report form is uploaded into the tracking
database and routed for approval to close.
6.3.10 The initiator, Quality and Engineer will approve the closure of the deviation in the
trackin database.

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