The dilemma of getting consultants to write your SOPs for you. Should you or shouldn’t you?
August 13th, 2019 by Peter CalcottAs a consultant, I am often brought in to assess systems, perform gap analyses or to audit. In many respects it is the same activity. I look at what is in place in the form of documents (SOPs and policies) and in processes in action in their operations. Some of these clients are large pharma or biopharma but a large number are relatively new and small operations with much of their activities outsourced to third parties.
Now let me stress, as a consultant, I am totally against getting consultants to write SOPs. It is not because I can not write an SOP. It is because a document that is written must be owned by the eventual company and to get ownership requires, in my mind, an active involvement in the production of the document and process. Ordinarily, I will supply key elements I would expect to see in a document or process. I will review the document to modify it to include elements forgotten or to restructure for clarity.
My approach is the same for both type of clients when I come in to assess. I use the classic moniker of “say what you do, do what you say, prove it, improve it” or putting it simply, documents, execution, records, improvements. So what do I see? In large companies, I often see well established elements with often strengths and weaknesses. So my tasks are relatively straightforward. But in small companies do I see the same? The simple answer is No.
What I see is groups of people working furiously to keep momentum going. This results in major gaps in systems. Many times, procedures are not in place and even if they are, they do not reflect the process in place. Particularly when procedures are in place they are written vaguely with no clarity as to process. When you interview people to gain clarity, you find their processes as verbally described are often quite robust. But it is just not described in any formal document. But since the company is small everybody knows everybody else and communication is very much ad hoc. While this may work initially, as the companies grow they lose that advantage.
So what we have to do is get them to think through the actual processes, write them down and immortalize them in policies and SOPs. This is easier said than done. They are so busy, they do not have the time to get it down on paper. On many occasions, to get them to a better state, I take on the task of writing it down, then getting them to check for accuracy and then shepherd the documents through the system. Ordinarily, I am not a supporter of getting a consultant to write an SOP for the company. Even if written very well, there is no ownership within the organization. But this is different. You are not inventing a new process to implement, it is writing down what is actually done. Or at least that is how I justify going against my own philosophy.
My goal is to put into place procedures describing what is actually done in the company, in a manner that if all the employees disappear overnight, to be replaced in the morning with new people, there is a good chance the processes would be executed similarly as before. In other word a robust sustainable process. This is the first step in building a rugged Quality Management System.