The QP

Question 1

What Makes a Good QP?

Answer 1

To be an effective QP you must be able to:
* Apply technical knowledge to real situations
* Take an holistic view; see the big picture

A QP must have the ability to draw conclusions when only a limited quantity of data is available. This means that a QP must understand the concept of UNCERTAINTY. A QP must be able to cope with ‘Life in the Grey Zone’; i.e. situations that are not clear cut or ‘black and white’.

Question 2

The QP role requires

Answer 2

the application of knowledge. A QP’s education must include opportunities to practice applying technical knowledge to a variety of challenging situations under the guidance of expert QPs who coach and mentor the trainee.

Question 3

In addition to technical skills a QP must have excellent non-technical skills such as:

Answer 3

Communication skills
* Interpersonal skills
* Problem solving
* Decision making

Question 4

Communication skills:
QPs must have the ability to:

Answer 4

Communicate effectively at all levels in the organisation, both verbally and in writing
* Effectively handle the communication of contentious issues
* Actively encourage free exchange of information
* Convey complex information in clear language suitable for the audience

Question 5

Interpersonal skills:
QPs must have the following influencing skills:

Answer 5

• Be able to present arguments based on sound business and technical reasoning with commercial awareness
• Team working – must be able to get individuals and groups involved and working together
• Planning and organising – must be able to organise priorities by discriminating between urgent and important

Question 6

Problem solving:
A QP requires a good understanding of problem solving techniques, including risk assessment:

Answer 6

Patient risk if batch released
* Patient risk if batch not released
* Business risk if batch released
* Business risk if batch not released

Question 7

QPs must develop skills and strategies to cope with and understand the level of uncertainty. These problem solving skills include:

Answer 7

Data gathering and analysis
* Questioning and listening skills
* Structured problem solving
* Risk management
* How to reduce level of uncertainty
* What to do when

Question 8

Decision making:
A QP’s role is ultimately about decision making. Hence, it is crucial that a QP has the ability to make a balanced decision that is:

Answer 8

Supported by data
* Endorsed by the business
* Accepted by regulators

Question 9

Decisions must demonstrate sound judgement and logical thinking.
QPs adding value to the business:
QPs must add value to the business that employs them by:

Answer 9

• Considering cost implications as well as quality but not compromise quality
• Maintaining his/her independence
• Working with the business team to solve problems; not create new ones!
• Proactively getting involved in new products, e.g. facilities design, early on in the project

Question 10

The QP should drive continual improvement by:

Answer 10

• Encouraging quality improvement
• Facilitating positive changes
• Ensuring accurate and timely documentation of changes
• Supporting the creation of workable change processes