Dirty dozen – Quality Systems Refresher Training

Training sessions that helps the organization create and renew its commitment to Quality work and GMP.

The idea with this model is to highlight a number of key factors underlying the so-called human factor.
There is usually something that precedes the human errors we make, and we need to understand these to prevent and minimize the risk of errors.

Depending on the time allocated for the training, a suitable number of factors are selected for the excersise.
Each factor has a number of questions to discuss and the goal is to identify what can be done better and how.

As a result, the participants create a document that can be used to initiate improvements in the operation. This can also be seen as an important part of the company’s responsibility to work with continuous improvements.

The 12 factors

1. Lack of Communication
2. Complacency
3. Lack of knowledge
4. Distraction
5. Lack of teamwork
6. Fatigue
7. Lack of resources
8. Pressure
9. Lack of assertiveness
10. Stress
11. Lack of awareness
12. Norms

Target group

The training is suitable for all categories of personnel who have previously participated in basic, intermediate or refresher GMP / Quality Systems training and have got at least two years’ work experience in regulated operations.
The training can be carried out in both mixed and homogeneous groups within e.g. operation / production, QA / QC, support and staff functions or others affected by the quality system.

Content

• Handling of incidents and deviations
• Preventive quality work
• The quality responsibility of the individual and the operation

Extent

1 – 3 hour sessions as per agreement

Implementation

Suitable mainly for intra-corporate groups with a maximum of 25 participants.

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