The medical industry obviously must comply with a series of strict rules in order to produce and sell pharmaceutical products. All the critical processes of GMP in the medicinal industry must therefore be supported by a series of relevant Standard Operating Procedures (SOPs).
Process control and zero variation are thus preconditions in order to produce and sell medicinal products.
In order to secure the quality of the GMP processes, the leaders of pharma companies sometimes have a tendency to make their employees read numerous and redundant SOPs to undertake their job duties.
But is the design of the quality management system always sufficiently pragmatic and business oriented? And is the training of the employees always relevant? In many cases the answer is NO.
Throughout the pharma industry there are discrepancies between the content of the very detailed SOPs and the concrete work tasks, and countless hours are wasted reading SOPs. A lot of very costly hours are being spent reading SOPs that the employees might never apply to their actual work and responsibilities.
By making relevant and focused training based on the need of each employee, the companies in question could save part of the substantial amounts that are being spent on training and education.
Through improved planning and targeted training, the project managed to lower the number of SOPs by 67 % in average, thus saving 16 mill DKK (2,4 mill USD).
Irrelevant training can have negative effects
Some 18 years ago, I was employed as Q-coordinator in a large Danish pharmaceutical company, and I spent the first month reading all the SOPs on my reading list. When the month had gone by, I was none the wiser, as to what the expectations to my concrete tasks actually were.
I found it strange that the company chose to train a new employee in this manner. But that was the customary procedure – and it still is.
The pressure on the pharmaceutical industry is huge. The quality of each product depends on the quality of the work of the employees in any given stage of the production process. Each employee must be able to deliver exactly what is expected of them.
However, if you introduce all employees to massive amounts of SOPs, they will be overwhelmed by the specifications of the potential of supplementary procedures that are not relevant to them. This will weaken the perception of compliance of the employee, and this can lead to increasing the risk of errors.
Consequently, training the employees can paradoxically result in major losses for the companies.
In the aforementioned Danish pharmaceutical company, I was responsible for a project to lower the number of SOPs for a group of 350 employees. For several years there had been discontentment regarding the number of SOPs that Marketing Directors, Brand Managers, Market Access Managers, Market Research Managers, Assistants and CVPs were supposed to read.
Many of the employees had to read 140 SOPs, potentially equaling 140 hours of reading time at some 500 DKK (75 USD) per hour. A total of 70,000 DKK (10,000 USD) per employee. The overall cost of the company was 24,5 mill. DKK (3,66 mill USD).
Through improved planning and targeted training the project managed to lower the number of SOPs by 67 % in average, thus saving 16 mill DKK (2,4 mill USD).
Waste of money and frustrations
Today, Vice Presidents and Site Managers with training responsibilities for leaders are afraid to be the cause of failing an internal audit, or an inspection by the authorities. Therefore, they make sure that too many SOPs are included in the SOP-portfolios of all managers.
This happens even though the relevance of the SOPs to the manager is nil. If we have 10 managers, then they will spend one hour reading and understanding the SOP, even though they do not understand why they have to do so. This exercise can amount to 5,000 DKK (750 USD).
Then add the frustration among the 10 managers, who will also have wasted time talking about why they had to read the SOP. They will debate the experience, possibly also on the next management meeting.
After that, 50 managers will discuss LEAN and optimization – and they will focus on unnecessary training. This could amount to 100,000 DKK (15,000 USD). Before long, the company will have spent a considerable amount on redundancy. These resources could have been invested in creating value for the firm.
Break down barriers and free hidden potential
There is no doubt that the pharmaceutical business in general could save millions by designing targeted, focused and relevant training for each employee.
However, a series of barriers need to be broken down in order to achieve this goal.
First of all, the process owners and their SOP authors need to understand that it has great consequences if they demand an ample application of the SOPs in combination with inexpedient training. They must also realise that it makes sense to limit the SOP in accordance with its primary purpose.
Secondly, the top management must be able to question the established system and see the advantages in changing it.
Thirdly, the managers must dare to discuss procedures instead of wasting everybody’s time by ignoring redundancies. Nevertheless, these factors are difficult to measure, because ‘the business-as-usual approach’ is often an integral part of a company’s mindset. Consequently, it is without consequence to carry out inexpedient decisions regarding the time usage on SOPs and training.
If Danish pharmaceutical companies want to maintain a competitive edge in relation to the increased demands of the market, they must also have the valor to challenge existing procedures. The Danish pharmaceutical industry has a large and hitherto unfulfilled potential for achieving substantial savings through targeted training and changed procedures.
However, this requires a change in scope, and a more targeted training of employees according to their specific needs. To achieve these changes, you need knowledge and courage.