**2.2. Process**

If we are dealing with a process we might need to be aware of:


Exactly as said above, this has to be done by people possessing or gathering this knowledge.

In this case, the table might appear like this one.

The approach to be followed is the same that was mentioned before.


Note: The contents of this table are just given as an example; they don't intend to represent any real situation.

**Table 2.** Table for process brainstorming

## **2.3. Comparison**

390 Risk Management – Current Issues and Challenges

helpful in performing this.

**Problems** (what can affect its quality?)

> Contamination (bioburden / pesticides)

The factors that might affect its quality

Particle size Inadequate particle

**Table 1.** Table for product brainstorming

Inquire regulatory authorities.

**2.2. Process** 

 Its flow-chart; Its equipment;

The likelihood of these factors and the effects of the loss of quality

**Causes** (what might provoke this problem?)

size

Product of natural origin

up, etc.) and then answering to "what would happen"? Ask people working or having worked in this situation.

If we are dealing with a process we might need to be aware of:

The factors which can affect them and the ways for doing this;

The approach to be followed is the same that was mentioned before.

Review technical literature and attend congresses.

*the process produces the desired quality* "in [4]".

In this case, the table might appear like this one.

The likeness and the consequences of these deviations.

And this can only be achieved by people possessing or gathering this knowledge and analyzing it subsequently by means of brainstorming. A table like the following one can be

> **Likeness** (is that likely to happen?)

Degradation Too high temperature Probable Determine acceptable temperature

Imagine different situations (e.g. change of supplier, lack of electricity, flood, error, mix-

 Its CPPs (critical process parameters), that is *process parameters whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure* 

Exactly as said above, this has to be done by people possessing or gathering this knowledge.

Note: The contents of this table are just given as an example; they don't intend to represent any real situation.

Several approaches have been proposed to facilitate this brainstorming, such as,

**Preventive measures** (what could we do to control or mitigate this problem?)

specifications

product

range

Yes Provide the supplier with detailed

Maybe Tight control of the sources of

And finally, if we are comparing two different situations, then we should identify:



Note: The contents of this table are just given as an example; they don't intend to represent any real situation.

**Table 3.** Table for comparing two different situations / elements

In this case brainstorming can be facilitated by:

