Issues - I
Quality Management manual not established in writing
Limited human resources
Lack of qualified people
Processes not properly validated
Poor SOPs or standard batch documentation
More consideration to cost than quality
Family members in key positions of authority
Issues to discuss
Imagine that within a company you are inspecting:
Quality Management Manual - Senior management will not allow a quality management manual to be created.
Limited human Resources - Owners will not recruit sufficient people to undertake the work. Existing staff are harassed and overworked. They are kept under pressure to perform and there are no spare staff with the skills and experience needed. When staff are ill or go on holiday then there are no replacement staff available.
Lack of qualified people - Unqualified or inexperienced people are employed in key positions.
Processes - Senior staff do not subscribe to the value of validated processes.
SOPs - There are few or no SOPs in operation. Those SOPs that do exist are not adhered to.
Standard batch documentation - Batch documentation is poor. Different batch sizes are made in inappropriate equipment.
Cost is emphasized over quality. The owners of the company do not subscribe to GMP other than the meaning "Get More Product". They see that GMP mean additional costs with no return. They do not subscribe to any moral code in respect of patient health. Any audit is seen as interference with their ability to manage the company the way that they want.
Family members play a major part in the company. Inexperienced or unqualified family members are promoted into positions of responsibility for which they are not qualified.
Imagine in a company you are inspecting: