Case Study - 01

Concerns related to Ethics and Compliance have been gaining significance among Indian pharmaceutical companies recently. The entire industry has been facing stringent regulatory and media scrutiny, and the cost of non-compliance is huge (a single warning known as 483 could lead to a drop in share prices by about 7-10%). While the opportunities are significant, at the same time it is essential for the organization to move from its usual bottom line-centric model to that of a transparent, comprehensive and implementable ‘Ethics & Compliance Model’, that matches global standards.

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Scope

Our client, a leading manufacturer of generic medicines for over 25 years, stood for quality and compliance, which came up consistently in the language of the senior leadership and all official communication. The organization however faced challenges, as the demands from the international regulatory bodies were being constantly updated, and that required a change in the behaviour of every single employee of the organisation. Coupled with a steady attrition and new hires, the organisation had a series of acquisitions which added to the diversity in the culture and behaviour pool.
The agenda was to develop a culture of excellence rather than compliance wherein each and every employee (entry-level to CEO) would be aligned to the company’s goals and aim for excellence in their individual roles.

Challenges

Challenging the traditional mindset across levels
Diverse and
Dispersed team
Adapting quickly to changing regulatory requirements

Approach

Built on the principle that each professional’s intent is to do well for the organization and self, the primary goal of SEEK was to carry on a dialogue with the employees. The dialogue would cover the purpose of the organization, what it stands for, its values, its goals, while also providing opportunities for the employees to speak up, engage and challenge each other. This offered a better understanding of what drives and motivates the employees while also providing details on:




  • Skill gaps and desired
    competence enhancements
  • On-ground issues
    and challenges
  • Process and system
    deficiences
  • Roadblocks to
    excellence



Customized content was then curated to address the skill gaps. The content (Pharma- specific like GDP, GMP, Data Integrity, etc.) was customized at a department and seniority level. The content was then pushed through the reinforced LEARN feature of SEEK. The LEARN section broke down concepts into short 5-minute daily "Learn Bytes" that were delivered through interactive text, videos and images, and ended each day with a task. The daily tasks measured knowledge, application of concepts and self-reflection. Self- assessment was driven through an Adaptive Assessment Technology that would ascertain the proficiency level of the employees and feedback (peers and managers). For other identified issues an action plan was put in place and measured regularly, in consultation with the organization. This process of Explore-Plan-Act-Monitor continued.

Benefits


The larger challenge in bringing about a change in attitude was overcoming the excuse of “We’ve always done it this way and haven’t had any issues”, “We’ve been audited many times with no observations”, and other similar arguments. Their logical brain agreed that change is non-negotiable and essential for the business, yet there was the inertia to change, which came from the comfort in familiarity. This was overcome by SEEK utilizing repetitive dialogue and reinforcement, which caused a dissonance in the brain between what is being done and what should be done. Post dissonance, intent nudged a change in behaviour.


Statistical Analysis


  • SEEK had an average engagement of 78% over the 12-month period.
  • The proficiency levels in assessments averaged at 2.7 on a scale of 1-5 (low to high).
  • The organization got 690 inputs of which, 105 were highly critical issues.
  • 26 difficult people decisions and 45 process corrections were made from the insights provided by SEEK.


A key lesson learnt was that SEEK identified a large number of confirmatory and corrective issues due to the blanket of confidentially it provided to the employees. The maturity of the people handling the SEEK reports needs to be aligned in favour of addressing the issues, and not the people themselves.

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