Pharma Voice

Conflict management in the pharma industry- Part 2

In the second part of their three -part series, Dr B Philip Ashok, Vice President-Quality, Star Drugs and Research Labs, and Dr SS Murugan, Scientific Director, RCC Laboratories India focus on the management’s point of views in the clash with QA teams

Dr B Philip Ashok is Vice President-Quality, Star Drugs and Research Labs, Tamil Nadu, India. He can be contacted at bphilip_ashok@hotmail.com

Companies belonging to regulated markets have already started to include quality audits and quality agreements in the initial sequence of activities/documents which are a part of the requirements to be fulfilled before any business proposal is finalised. Also, the responsibility of the GMP is very clearly stated in the agreements. This gives the needed thrust and importance to GMPs even before the work/ job orders are finalised. Now, business managements have the responsibility to provide high quality products and the points of conflicts are analysed below. Conflicts can be resolved if the point of conflicts are better understood.

Points of conflict

Timelines

Dr SS Murugan is Scientific Director, RCC Laboratories India, Hyderabad, India. He can be contacted at siva.murugan@rccltd.in

This importance has to be sustained throughout the execution of any project and all timelines shall give the required scope to QA for a very thorough review of the documents, verification of the raw data, and interview with the concerned staff who have been part of the execution and to do necessary corrective actions when required. This is the responsibility of the Business Management to ensure that the timelines are committed with enough consideration to fulfill the GMP requirements and for a detailed and constant intervention and review by QA.

Now, this timeline in most cases does not satisfy the QA team (or) a timeline which satisfies the QA team initially may finally turn out to be inadequate since the operations/R&D (teams) run into problems which cause delays that finally eat into the allocated QA timeline. Conflict is defined by one expert as “a situation in which two or more human beings desire goals which they perceive as being attainable by one or the other but not by both." This is can be better understood by the below explanation:

• The Management feels that this is the right timeline to execute and also probably to gain repeat orders as most of the customers want results faster. (The thinking is that without this short timeline we would lose the next order)
• On the same project, the QA unit feels that a lengthier timeline would have helped the QA and thereby the company to have performed to match GMP requirements better so that the company gets repeat orders. (The thinking is that without the proper time for QA which has resulted in shortened review times we may lose the next order).

In the present scenario, both are possible occurrences, that is, business/customer loss may occur due to both. But, the second scenario could lead to a serious loss including loss of the customer relationship and sometimes to the extent of being black listed by that particular company (or) country. Hence, there arises a need for managing the conflict and arriving at a solution.

Communication

The management is responsible to communicate their overall business strategies, specific strategy towards a particular type of business, their short term and long term goals and plans. Also, every project has to be very clearly communicated to all the departments including the QA unit as communication gaps in the present scenario can be dangerous and it can jeopardise the business potential of the company. "Over communication" is better than "under communication" One management author has endorsed the view that "over communication" is indirectly contributing to clear communication through all the ranks of the employees. This kind of communication generally automatically leads to consensus and the conflict is avoided there itself. All those concerned feel important since they were included in the communication and therefore they want to work hard for the success of that project. Lack of proper/clear communication from Management and the resultant effect on employee morale is a reason for conflict.

This is can be better understood by the below explanation:

• The Management feels that communicating full details of the business/project to the QA Unit may give rise to some negative opinions and contradictory feed backs. Hence they finalise the project and then communicate as they would have no other option in order to gain business.
• On the same project, the QA unit might not put their whole hearted efforts just because they were not included in the communication (or) consulted and hence due to this feeling of being treated as less important, they develop a wrong understanding that the project might not be successful. Also, in case of a multiple project scenario, they may not give due importance as there was not enough communication.

Resources

Before committing to any project, the Management must consult the Quality unit and all the technical team representatives to ensure that necessary resources are available. Again, here, some of the business managements take a different approach as discussed in the above topic to finalise the project and then try to convince the technical team to go ahead with the available resources. Here, a similar conflicting situation as in the case of "Communication" arises where because the management has finalised the project without confirming on the resource availability with the QA/ Technical team/ the QA Unit (or) the technical team tends to believe that the project may not be a success and there is always a conflict going on which results in lesser success.

Training

Training is a key factor that is considered by the Management before finalising a business deal. The plans and costs for training have to be factored into the business costing. Training remains a neglected component even though the trend is changing. Here again, some managements tend to suppress the fact that training is required to execute a project to increase the profitability, but, this has already given rise to a conflict in the sense that the QA unit will insist on training for the technical team as well as the QA unit and this conflict also can contribute to GMP and product quality issues. Also, the QA unit and the technical team develop a kind of defiance which affects the execution very badly. The conflicts arising due to the four factors mentioned (namely: timelines, communication, resources, training) have to be managed and resolved. The points of conflicts discussed above will not fall into the interpersonal or intrapersonal conflicts, but, these are called 'substantive conflicts' which means in a way conflicts over goals, values or methods.

(The authors welcome feedback at bphilip_ashok@hotmail.com and siva.murugan@rccltd.in. The third and concluding part of this series will present the QA department’s point of view and ways to resolve the various scenarios existing in companies today due to this conflict.)

To be continued…