T3A INDUSTRIAL

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Issue # 01

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STANDARD OPERATING PROCEDURE

TITLE: QUALITY RISK MANAGEMENT (QRM)

ISSUE DATE: //.

EFFECTIVE DATE: //.

ASSIGNEE

REVISION DATE: //.

NAME

TITLE

PREPARED BY

IBRAHIM ABD ELGABER

QA OFFICER

REVIEWED BY

IBRAHIM ABD ELGABER

QA SUPERVISOR

APPROVED BY

SALIL SAKSENA

S.QA MANAGER

SIGN./DATE

HISTORY OF CHANGE

ISSUE #

ISSUE
DATE

PAGE #

SUMMARY OF CHANGE

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1. OBJECTIVE:
1.1.

To provide the management of all risks that may affect in quality system.

2. SCOPE:
2.1.

Applied to different

aspects

of

pharmaceutical

quality; including development,

manufacturing, distribution, and the inspection and submission/review processes

throughout the lifecycle of drug substances.

3. RESPONSIBILITY:
3.1.

Departments manager or designee: Nomination of the QRM team members each manager in
his position, following up with the QRM team leader the activity of QRM team
members.

3.2.

QRM team leader or designee: Following up the activities of the QRM team members.

3.3.

QRM team members: Carrying out the objectives and tasks that decided in the meetings
with in the due dates.

3.4.

QRM Co-ordinator or designee: Preparing the required documents, Issuing of the controlled
documents.

3.5.

QA Manager or designee: review approval and system compliance.

4. PROCEDURE:
4.1.

Formation of QRM team

4.1.1. QRM team in T3A factory consists of two divisions. One for Ceph factory and other for
Pharma factory.
4.1.2. Each team is cross function team (team members are from different departments) and the
members shall have specific knowledge and expertise regarding the product and
process.
4.1.3. The plant manager shall nominate the QRM team leader.
4.1.3.1.Ceph QRM team members shall include:
4.1.3.1.1.One member or more from Ceph QC department.
4.1.3.1.2.Two members or more from Ceph production department.
4.1.3.1.3.One member or more from maintenance department.
4.1.3.1.4.One member or more from R&D department.

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4.1.3.1.5.One member or more from warehouse department.

4.1.3.1.6.One member or more from QA department.
4.1.3.2.Pharma QRM team members shall include:
4.1.3.2.1.One member or more from Pharma QC department.
4.1.3.2.2.Two member or more from Pharma production department.
4.1.3.2.3.One member or more from maintenance department.
4.1.3.2.4.One member or more from R&D department.
4.1.3.2.5.One member or more from warehouse department.
4.1.3.2.6.One member or more from QA department.
4.1.4. Team members shall be able to:
4.1.4.1.Identifying potential risks.
4.1.4.2.Conducting a risk analysis.
4.1.4.3.Making the risk evaluation.
4.1.4.4.Identifying the method of reduction of each risk.
4.1.4.5.Recommending controls and acceptance limits.
4.1.5. In the first meeting ,the formation of QRM team approval form (attachment 5.1.) shall filled
by the team, signed by the Production manager, QC manager , Maintenance manager ,
R&D manager and QA manager
4.1.6. The formation of QRM team form shall be approved by the plant manager
4.1.7. In the regular meetings; QRM coordinator shall draw up the minutes of meeting in the QRM
meeting minutes form (attachment 5.2.) which shall be signed by each attended member.
4.2.

Manufacturing flow diagram:

4.2.1. QRM team shall prepare a manufacturing flow diagram for each product or the products that
have same dosage form and the same sequence of stages, the stages starting from
materials receiving up to finished product handling, each stage consist of many
sequenced processes.

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4.3.

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Risk Assessment:

4.3.1. Risk Identification:

4.3.1.1.

QRM team shall define the processes as shown in the flow diagram.

4.3.1.2.

Each process shall be has a potential risk(s), The QRM team shall list all the risks that
may be reasonably expected to occur at each step of production.

4.3.2. Risk analysis:

4.3.2.1.QRM team shall define the reasons and impacts for each defined risk.
4.3.3. Risk Evaluation:
4.3.3.1.

QRM team shall compare the identified and analyzed risk against given
risk acceptance criteria.

4.3.3.2.

The "risk score" shall be used to further define descriptors in risk ranking.

4.3.3.2.1. Risk ranking process shall be carried out based on three item which are
(Frequency/Probability), (Scale/Duration), and (Severity of the risk).
4.3.3.2.2. Each item has five scale degrees ranged from 1 to 5 as shown:
Rank Frequency / Probability

Scale / Duration

Severity

Rarely happen (Monthly)

VS volume/quantity (Instance)

Hardly happen (Weekly)

S-volume/quantity (Few seconds)

May happen (once/day)

L-volume/quantity (less than hour) Correctable

Often happen (Once/shift) M-volume/quantity (for hours)

More difficult to correct

Always happen
(continual)

Complex effect with

complicated solution and great
effort for correct.

H-volume/quantity (for days)

Not likely to effect

Easy correctable, short term,
clearable

4.3.3.2.3. From the above ranking system calculate the potential risk degree by summations of all
the parameters together and dividing the result by 15.
4.3.3.2.4. Risk class is determined according to the ranking results as follows :

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Ranking result

Class

(Below 40) %

(low)

(40-80) %

M (Medium)

(Above 80) %

(High)

Example: consider the aspect (X) which often happens once per day with high volume with low
severity:

4.4.

Risk

Frequency

Scale

Severity

Ranking

Class

10/15

66

M (Medium)

Risk control:

4.4.1. Includes decision making to reduce and/or accept risks.

4.4.2. The purpose of risk control is to reduce the risk to an acceptable level (attachment 5.6.).
4.4.3. The amount of effort used for risk control shall be proportional to the significance of the
risk.
4.4.4. Risk Reduction:
4.4.4.1.Focuses on processes for mitigation or avoidance of quality risk when it
exceeds a specified (acceptable) level.
4.4.4.2.Risk reduction shall include actions taken to mitigate the severity and
probability of harm.
4.4.4.3.Processes that improve the detect ability of hazards and quality risks shall
also be used as part of a risk control strategy.
4.4.4.4.

The implementation of risk reduction measures shall introduce new risks

into the system or increase the significance of other existing risks.

4.4.4.5.

Hence, it shall be appropriate to revisit the risk assessment to identify

and evaluate any possible change in risk after implementing a risk
reduction process.

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4.4.5. Risk acceptance:

4.4.5.1.

Risk acceptance can be a formal decision to accept the residual risk or it can be a
passive decision in which residual risks are not specified.

4.4.5.2.

For some types of harms, even the best quality risk management practices might not
entirely eliminate risk.

4.4.5.3.

In these circumstances, it shall be agreed that an appropriate quality risk management

strategy has been applied and that quality risk is reduced to a specified
(acceptable) level.

4.4.5.4.

This (specified) acceptable level shall depend on many parameters and shall be decided
on a case-by-case basis.

4.5.

Risk Review:

4.5.1. Risk management shall be an ongoing part of the quality management

process. A mechanism to review or monitor events shall be
implemented.

4.5.2. The output/results of the risk management process shall be reviewed to take
into account new knowledge and experience.

4.5.3. Once a quality risk management process has been initiated, that
process shall continue to be utilized for events that might impact the
original quality risk management decision, whether these events are
planned (e.g. results of product review, inspections, audits, change
control) or unplanned (e.g. root cause from failure investigations, recall).
The frequency of any review shall be based upon the level of risk.

4.5.4. Risk review might include reconsideration of risk acceptance

5. ATTACHMENT:
5.1.

Formation of QRM Team approval.

5.2.

QRM team meeting minutes.

5.3.

Risk Assessment.

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QRM Team (Format Unique# 0132)

QRM Team Activity area: .

Number of members: .
Ser. #

Member name

Date: ..........
Department

Signature

.......... ...

...

.......... .

...

.......... .

...

..........

...

..........

...

..........

...

..........

...

.......... ..

...

.......... ..

...

..........

...

.......... .

...

..........

...

..........

...

QC Manager Approval: ......

Production Manager Approval: ......
R&D Manager Approval: ......
Maintenance Manager Approval: ......
QA Manager Approval: ......
Plant Manager Approval/Date: .

Position

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5.2. QRM team meeting minutes (Format Unique# 0133)

QRM Team activity area: ...
Date: . /.. /..
Time: from : to ...:
Attendance / agreement:
Ser.#

Name

Dept.

Sign.

Remark

............................................................. ..

..

............................................................. ..

..

............................................................. ..

..

............................................................. ..

..

............................................................. ..

..

............................................................. ..

..

............................................................. ..

..

Decisions and responsibilities:

Name

Responsible for

Due date

.................................

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QRM Team Leader sign/date: .

Page (

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5.3.

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Risk assessment (Format Unique# 0134):

(*) L = Low

Potential Risk

M = Medium

Reasons

Impact

H = high

QRM Team Leader sign: .

Page ( ) of ( )

Class*

Rank

Process

Frequency / Probability
Scale / Duration
Severity

QRM Team activity area:

Control

Reduction
L M H

Acceptance
(According To)