Insight is regularly brought on by clients to provide creativity and to help with the innovation efforts. We work regularly within our client’s quality management systems (QMS). One of the biggest misconceptions that we see is the belief that there is a natural conflict between a QMS and creativity and innovation. It’s easy to understand why this belief exists because of the misapplication of many QMS during innovation and product development projects. A properly applied QMS should enhance creativity and innovation, not hinder it. The five most common reasons we’ve seen for the conflict between a QMS and creativity are:

1. Overburdening the process due to a lack of understanding of the intent of a QMS
2. Lack of controls
3. Applying the same QMS to every project and organization
4. Allowing the QMS to become the development process
5. Poor communication

From our own efforts and from those of companies that we’ve seen who have little or no conflict, there are four key ways to minimize conflict.

1. Better program management
2. Better judgment
3. Education of the team
4. Better understanding of a project’s intent.

Better Program Management

The source of conflict most often begins with poor program management. Program management can be the solution if it is approached as being more than just an administrative role, if it is less prescriptive in methods and processes, frames the project objective properly, brings together the appropriate team, embraces different thinking and fosters communication between all team members, especially between the “creatives” and the implementers.

Better Judgment

A trait that a good program manager has that can reduce the QMS and creativity conflict starts with an understanding that freedom equals risk. How much risk can be accepted is important. Risk in and of itself is important but if it’s monitored properly, if there are checks and balances along the way, freedom can be increased without risk being beyond acceptability. During the early stages of a product when requirements are being discovered and defined and innovation and creativity for defining new products and use cases, heavy handed QMS processes can have a negative effect. From careful reading of a QMS (ISO13485) it’s clear that there are only a handful of incidences where a QMS process is important to have at the early stages.

These are:

• Careful definition of objectives and scope
• Identification of proper roles and responsibilities
• Appropriate mitigation of risk
• Definition of deliverables and expected outputs
• Realistic assessment of schedule and budget

Education

It’s difficult for a program manager or anyone on the team to exercise good judgment unless they understand what is really happening. Something related to this is how there is a stereotype that a conflict between QMS and creativity is inherent and a constant tension where one thing must give for the other to succeed. Understanding the “spirit of the law” is important for everyone on the team. What is the purpose of the QMS? If you read carefully, a QMS is primarily in place to ensure that “customer and regulatory requirements are satisfied.” ISO13485 explicitly says that the QMS is not intended to be the development process and it is there to monitor what is happening and to measure continual improvement. Much of the conflict between a QMS and creativity happens as a result of a lack of understanding of what the purpose of a QMS really is.

Intent

Program intent is a key factor in reduction of conflict. It is important for everyone on the team to understand the intent of what they are trying to build. Is it to copy a competitor or to be an innovative solution? Is it to provide more value or to sell at a cheap price? While these seem like simple questions that should be understood from the start of a project, it is often the case that creativity can be stifled or misdirected by not focusing on the true intent of the project.

The most important realization is for companies to recognize that a conflict does not have to exist between their QMS and innovation and creativity. It’s the misapplication of a QMS through poor program management, lack of judgment on how and when to apply it, understanding of the purpose and boundaries of a QMS, and intent of a project.