After having looked in the quality mirror, you can ask yourself: “Do I like what I see?”
Like many things in life, quality is to be considered a journey rather than a destination and requires a continued level of attention. Therefore, it is very likely that your assessment outcome indicates that small or large adjustments are advisable.
It is important to realize that quality cannot be the responsibility of one single person or an isolated group of quality professionals in your organization. Quality is really everyone’s responsibility and should be embedded in the DNA of both people and processes. The right people need to be involved in order to have true impact.
Therefore, after analyzing your quality image, it is important to articulate very clearly what you see, why improvement is needed, and who needs to get involved. Also, one should not forget to bring a well-balanced message, adapted to the target audience, and remember to emphasize what is already good.
Another common mistake is to think that research quality principles can be installed just by writing a policy, generating procedures and guidelines, and organizing training sessions, so everyone knows what to do. This may look good on paper and may even be designed to be lean and fit-for-purpose. However, building quality into the everyday activities and at all levels requires to go beyond work instructions and policies. It is the emotional connection that is the basis of success (Fig. 3) since this will make sure that quality is built into the thinking and actions of everyone involved. One can never foresee all potential situations and exceptions in a procedure, but having people’s mindset right will trigger the right behavior in any situation.
Here are some hints and tips and practical examples that have been shown to be well received:
Positive communication is key to obtain engagement. Phrases such as “How can we set ourselves up for success?” or “How can we increase our potential for innovation?” are much more effective than “We need to follow these rules for data recording.”
Scientists are excellent problem solvers. This skill can also do magic beyond the scientific area of expertise such as on quality-related topics. The only trigger that is needed for the scientist is the awareness that there is a situation that needs to be addressed. In this context, quality professionals are advised not to impose solutions on scientists, especially when these solutions may be perceived with even a tiny piece of increased bureaucracy. And, in the end, scientists usually know best what works well in their environment.
As an example, a campaign appealing to scientist’s creativity can result in very engaging visuals that can be displayed in labs and corridors (example in Fig. 4) and will become the talk of the town. Positivity, creativity, and fun are key elements in building a research quality culture.
The first question you will be asked by your institutions’ leaders is “Why is this important?”. You need a clear outline of what is at stake, what you learned during the current state analysis, and where you see gaps and a plan for change. It is best to include real examples of what can go wrong, what is currently already working well, and where improvement is still possible. Without support of the institutions’ top leadership, the next steps will be extremely difficult or even impossible.
It is highly likely that during your initial analysis, you have met individuals who were well aware of (parts of) the gaps and have shown interest and energy to participate in finding solutions. Chances are high that they have already started taking steps toward improvement. It is key to involve these people as you move on.
It is also likely that your initial analysis showed that, in certain parts of the organization, people have already put in place solutions for gaps that still exist in other parts of the organization. These can serve as best practice examples going forward.
Also, you may have come across some very critical people, especially those who are afraid of additional workload and bureaucracy. Although this may sound counterintuitive, it is of high value to also include this type of people in your team or to reach out to them at regular intervals with proposed (draft) solutions and ask for their input.
Finally, since the gaps you have discovered may be of diverse nature, it is important to involve experts from other disciplines such as biostatisticians, communication professionals, patent attorneys, procurement experts, IT experts, etc.
The gaps, best practices, and route causes defined during the initial analysis will be the starting point for change. Remember that route causes are not necessarily always of technical nature. Cultural habits or assumptions may be equally or even more important and will often take more time and effort to resolve.
It is also important to try not to change everything at once. It is better to take small incremental steps and focus on implementing some quick wins first.
Apart from prioritizing the topics that need to be tackled, it is good practice to define roles and responsibilities as well as a communication plan. For a large organization, it may be helpful to agree on a governance model for which an example is given in Fig. 5.
Change is never an easy journey, and awareness on change management principles will be helpful to achieve the ultimate goal. On the web there is a lot of useful material on change management, such as the Kotter’s 8-step change model (https://www.mindtools.com/pages/article/newPPM_82.htm) that explains the hard work required to change an organization successfully. Other useful references are the RQA (Research Quality Association) booklet “Quality in research: guidelines for working in non-regulated research” that can be purchased via the RQA website (https://www.therqa.com/resources/publications/booklets/quality-in-research-booklet/) and the RQA quality systems guide that can be downloaded for free (https://www.therqa.com/resources/publications/booklets/Quality_Systems_Guide/). Careful planning and building the proper foundations is key. Equally important is creating a sense of urgency and effective communication (real examples, storytelling). Having some quick wins will help to build on the momentum and increase enthusiasm.
Try not to make guidelines too descriptive or specific and rather go with general guidance. For example, it is essential that equipment is suitable for intended use and that experimental records provide sufficient details to enable reconstruction. What exactly this means depends on the type of equipment, for what purpose it is used, and what type of experiment is conducted. General templates to document equipment maintenance or reporting templates may be helpful tools for scientists; however, it is key not to go in too much detail when specifying expectations.
Interactive and fun activities during training sessions and hands-on workshops are generally well appreciated by the scientists. As an example, a quiz can be built into the training session during which scientists can work in small teams and get a small prize at the end of the session.