The Policies, Procedures and other Quality Documents that we use as a backbone to our daily PV activities are the fundamental references for ensuring the consistency of the execution of our activities. They also ensure adequate documentation of the compliant execution of processes. What is often underestimated are the difficulties lying ahead of us when developing or updating these reference documents. Have you ever been frustrated by the time it takes to revise or create an SOP because of an infinite loop of review and unnecessary comments and revisions? We all strive for speedy and efficient processes in our activities, including in PV. Writing SOPs on PV processes should be the same. Are there techniques or skills that we can borrow from Leadership to facilitate the too often strenuous exercise of writing SOPs?
Create Consensus and Teamwork
Great leaders are not the ones who constantly take executive decisions against everyone else’s advice. Great leaders empower teams, create consensus, and get an agreement on what to achieve, on how to achieve it, and when and how to deliver results. The same goes with SOPs and process definition. The most common and costly mistake when describing activities in quality documents is to maintain the existing process without challenging its efficiency, or worse, writing a new SOP without giving the stakeholders a good chance to chime in and rally around a commonly agreed upon new way of working. This is a recipe for a very painful document review, and very poor compliance when the process will be enforced. Writing SOPs is almost similar to a creative writing exercise: write the story line first, agree with the group on the roles and responsibilities and then write down what has been decided together. This will ensure a smart and efficient process design, a shortened SOP preparation and great compliance later, because all contributors will already be familiar with the process, and will need a limited training on it. Magic!
Define and Communicate the Vision, Strategy. Be clear on the Priorities
One of the reasons for developing and updating PV SOPs is the need to maximize the compliance to regulations and best practices, and maximize the strategic output of PV work. But above all, we want to avoid gaps and insufficiencies because of the risks for patients, for the company’s products, and from the regulatory authorities. SOPs are key tools allowing to fulfil the company mission about saving and improving patients’ lives. If you need a Signal Management and Risk Benefit Assessment SOP because of a significant gap in your growing organization, every passing day means that the company has not fulfilled its ethical commitments. There is no real justification to take several weeks (per reviewer…) to spend just one hour to review a proposed draft. You should always communicate the vision and objectives of what you want to achieve when circulating a document to review: “Our Company wants to minimize the regulatory risks and maximize our focus on patient safety by enhancing this SOP on [insert title here]. Please help us achieving this objective by reviewing this attached document no later than [insert date here]”. Why not try this?
Lead by Trust, Oversight and Delegation
As needed, all processes including critical PV ones, should include a control loop and oversight. This does not mean micromanaging and challenging all decisions. If a trusted group such as PV is deemed experienced and skilled enough to handle signals and benefit-risk assessment, the team should be empowered to do so, with an executive oversight level aimed only at two targets: agreeing upon significant actions to reduce risks to patients (significant label change, protocol update, etc.), and ensuring that the systems work as expected by reviewing PV compliance and activities metrics. Too many cooks in the kitchen will not produce good results. At all levels in an organization, once someone has been deemed qualified to do the job after an adequate training program, including shadowing, mentoring and coaching, the individual(s) should be able to execute tasks with minimal supervision and maximal autonomy. Too often, companies add in SOPs several executive review loops for any single PV action, such as deciding on the reportability of a SUSAR or a decision on a potential signal (refuted or confirmed). It only demonstrates a lack of trust and will lead to inefficient output, with a PV group which will not feel empowered and trusted. Oversight and control is always needed in any process or organization. Micromanaging activities is never a good leadership style. Trust by verify, empower and delegate instead.
What are the other leadership skills that you think could apply to process design and SOP writing?
JP Clement, MD