At some point, someone is going to ask about your company’s Quality Manual and Management System. You may get a questionnaire from a distributor that asks for a copy of your manual or when you hire your Director of Quality they will ask if you have one. You can take steps now to start developing your system. By thinking through what the right Quality Management System is, rather than generating something in a rush, your organization can build something that is useful and generates value.
Before we talk about quality management system, we should talk about what “quality” is. Quality broadly refers to one of four aspects of your company and product:
The first type of quality can’t be formalized; it is part innovation and part diligence. However, the other three require an organization to be more formal and disciplined about how quality is defined, verified and how the processes are executed.
What are the parts of a Quality Management system?
Googling the term “quality management” will turn up an alphabet soup of acronyms and terms. They aren’t always used consistently across sites and it can be quite confusing. Here are the most common definitions used by industry:
When you google these terms, there are some very scary pages about get certified and sample quality manuals that are full of jargon and verbiage. Your likely reaction is not going be “wow, this sounds really useful and will help me.” Likely your first reaction is “this is not the way we run things,” “we can’t be this rigid in our approach we need to be flexible,” and “we aren’t big enough to need this formal process.”
Creating the framework for a formal quality management system is pretty straightforward. Once the framework is created, it becomes a living document that will grow and change with your company’s growth.
“What is a quality manual?” is a question I get a lot from small organizations. They know they need one (usually because a customer asks for it) but are very scared off by the IS9000 requirements huge manual and the sheer volume of work to get a very large brick of paper. Often the work to develop these policies and procedures end up as a very expensive doorstop.
The ISO sets a very formalized organizational structure, which you can choose to follow if it works; otherwise, you can create a much simpler version which just contains the processes critical to your business. At minimum, a quality manual should contain the following:
The quality policy is the first element of the quality management system. It is a kind of mission statement for how your organization approaches quality. You can find lots of examples on the internet. While this can seem like make-work, it is important to have the discussion about what aim you have for the quality of your product. At some point a tradeoff between the various aspects of quality may need to be done: for example, between a new innovative feature and the potential durability issues. The corporate quality policy should provide guidance on how those tradeoffs should be made.
Why do you need to define your business and processes? When companies are small and there are a limited number of people, you can solve problems and keep track of issues by shouting across the desk. Problems crop up and you just solve them quickly. If customers complain, you have a phone call, brainstorm and get a solution in place. Everyone is empowered to make decisions. This flexibility and speed is critical in the early stages of a product but can become a liability later on. As companies grow, you will have more people to keep in the loop, more issues to keep track of, and you will need a standard drum-beat process for defining and communicating the forecast.
It will be necessary to define some key processes and get agreement on how they should be done. This ensures that the process is done the same way each time and that new people in the teams learn the right way first. Here are a few processes that are beneficial to standardize and document.
ISO certification is a very long and time-consuming process. It can take many person years to develop the documentation of all of the processes, ensure it is in the right format and then the process of auditing. There are many consulting organizations that you can pay to help you but the process is expensive and distracting. For small companies without their own internal manufacturing, the value of getting ISO certified usually doesn’t justify the expense and resources (which could be used to develop the next product). You should select a contract manufacturer who has an ISO certification. That along with your quality manual should be enough to satisfy any requirements.
What are the first steps in getting your Quality Management System defined.