iv. It can be applied in both ways, i.e. either proactively or retrospectively.

WHO Guidelines for Transfer of Technology 69

Principles of QRM

i. The evaluation of the risk to quality should have a basis and ultimately link to

the protection of the patient.

ii. The level of effort, formality and documentation of the quality risk management

process should be commensurate with the level of risk.

iii. When applied, the methodologies of QRM should be dynamic, iterative and

responsive to change.

iv. There should be capability or scope of continual improvement in the QRM process.

QRM Process (Fig. 5.2)

Initiating a QRM process: The initiation of QRM should have a scientific basis. The

possible steps to be taken in initiating and planning a QRM process are shown in

Fig. 5.3.

Fig. 5.2: QRM process

Fig. 5.3: The possible steps to be taken in initiating and planning a QRM process

70 Industrial Pharmacy II

Personnel involved in QRM: The personnel involved in QRM should have productspecific knowledge, experience and expertise. The personnel should be capable of

effective planning, execution and completion of QRM activities. The team can be

multidisciplinary. The duties and responsibility of the team are to:

i. Conduct risk analysis

ii. Identify potential risks

iii. Analyse the potential risks

iv. Evaluate the risks to determine which one should be controlled and which one

should be accepted

v. Recommends risk control methods

vi. Create a procedure for risk review, risk monitoring, and risk verification

vii. Calculate the impact of risk finding on related product/processes.

Knowledge of product or process: A flowchart could be made to assess every step of

product and process. QRM should be based on the knowledge of product and process

concerning to the stage at which product is there in its life cycle.