Company Organization in the New Pharmaceutical Quality System

Company profile:

Pharmaceutical company with more than 30 years of history that has been adapting to changes in the sector but is concerned that the efforts made in recent years to adapt to the requirements of the pharmaceutical quality system do not give the expected result. Multiple problems are identified in the quality processes and in the manufacturing processes (number and fluidity of the resolution of deviations, failures in the management of prospective changes, deviations from external audits, failed industrial transfer processes, etc.). High non-quality costs.

Project scope:

Redesign of the organizational structure of the company for its adaptation to the new challenges posed by the new approach to pharmaceutical quality system.

Project duration:

2 years in 4 phases

Project outline:

Phase 1: Assessment and diagnostic

In this phase the current scenario was characterized. Staff interviews, quality and knowledge processes, responsibilities and quality unit role characterizations were performed. Finally the diagnostic was stablished and the project objectives, brand and the correspondent “story” was created.

Phase 2: Design of changes with key staff

Key processes and stages were selected and functional process owners were identified. Simultaneously, a processes map, with the interrelations between processes clearly shown, was elaborated.

Additionally, the required profile (education, experience, talents and skills) for the key positions were established and the necessary selection processes started. Finally, the stages and actions of the implementation of the changes were planned and the performance indicators were identified to allow the follow-up and anticipation of problems.

Phase 3: Communication, training and workshops

An internal communication campaign was conducted for the promotion of the objectives to be achieved collectively, associating the objectives with the brand and the project story.

Key processes were segmented and training sessions and workshops were held, seeking to strengthen the interrelations between the different areas of the company (transversal processes), thus facilitating the alignment of decision-making criteria.

Phase 4: Follow up and reinforcement

Indicators are monitored periodically to evaluate the level of progress in the project. The periodicity should be adjusted, initially intensively and progressively over longer periods as the change is consolidated.

Corrections should be made if deviations are found in the indicators.

Impact must be evaluated Before implementing changes.

Results:

As a result of the redesign project the following benefits were achieved:

 Staff appears more motivated, with a stronger feeling of pertinence.

 There is an increased self-confidence about the capabilities and the success within the company.

 Common objectives are clearer.

 The organization is more transversal.

 Talent is more easily identified and has a chance to develop.

 Quality indicators improve. The number and criticality of incidences is reduced significantly.

 The efficiency is clearly increased.

Conclusion:

Having the support of a company such as TDV, with proven experience in consulting, allows an improvement in the efficiency of pharmaceutical quality systems. The strategic planning guarantees security in the achievement of the intended objectives, always in a controlled manner, and allows the contracting company the guarantee that it will be able to prioritize the allocation of resources.

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