Audits help in hardwiring the need to be compliant with the laws of the land and regulations into the culture of the pharmaceutical company
Lupin delivers medicines all round the world and it is important for customers to know that the medicines they buy come from manufacturing sites that are fully compliant with local laws; this is where audits enable our reputation capital. In the pharmaceutical industry, where extensive documentation is required, it is also important for the employee to know that the company cares about the laws of the land and the expectations of the regulatory authorities. Audits help in hardwiring this into the culture of the company. Best practices in audit must ensure that laws are complied with, in both, letter and spirit.
The kinds of audits that we conduct can be categorized into two types: compliance audit and process review audit. We also undertake a social accountability audit – SA 8000 which is an auditable certification standard that encourages organizations to develop, maintain and apply socially acceptable practices in the workplace. We ensure that all the relevant stakeholders are present when the audit report findings are presented. The goal is not to pin-point responsibilities but rather identify areas of improvement. Most of the findings in the audit revolve around ensuring timeliness and quality. In the last five years, our site scores have improved and the focus has been on ensuring that results move upwards.
Learning and Development Audit
In case of process review audits, the case of auditing the L&D process has seen significant results. Often, any L&D initiative is viewed as a step in the right direction within the HR community. And feedback conducted at the end of the program is usually the only metric that is used to evaluate the success of the training program. However, this method is not useful because the feedback is usually positive and it does not track how such knowledge is applied to the job on a day-to-day basis. We may be running the best initiatives but audits enable our processes to be ratified.
At Lupin, we administer most of our learning and training initiatives at the training center at Lonavala. The approach to auditing our L&D initiatives has been two-fold: one is the content delivered, which includes review of the program, instructor and pedagogy by third party experts. Depending on the duration and scale of the program, we have also involved inter-departmental auditing. The second measure has to do with assessing the impact on the learner for which we employ the “Kirk Patrick model of evaluation”. The four levels include: 1) Reaction, 2) Learning, 3) Behavior and 4) Results. We establish a baseline score that is based on past performance and see whether there has been a change across different geographical regions.
Apart from all the above activities, every year we pick three sites and conduct surveys called “People Pulse” and also participate in external surveys that allow us to benchmark our practices and learn from the best.