Quality System – Where Do We Start?

You have decided that you need a new or improved quality system, and now the question is, where do you start? To quote Stephen Covey, begin with the end in mind. Does the organization need or wish to pursue an ISO certification, Nadcap accreditation, or FDA clearance? If not, does the organization wish to conform or comply with a reference standard as a good business practice? It is important to have a goal, so that you can plan accordingly, and then follow through. For example, you may wish to follow the Plan-Do-Check-Act cycle for your new or improved system. In other words, plan what you are going to do to meet the goal; do what you say you plan to do; check to determine if you met the goal; act if refinements or changes are needed, and determine where to go from here.

Typically, the best place to start is to prepare a system description and process descriptions, beginning with what the company actually does. And, the best way to prepare a description is to start with a process map or flow diagram of what you do. Starting with a “picture” will make writing the text, as needed, easier. Starting with a picture will also help identify inefficiencies, potential bottlenecks, and sub-optimal business practices, which then can be addressed. Later, having a picture will make training and daily reference by the users easier. Here are the basic steps of how to approach your quality system.

  1. Flowchart what you do.
  2. Write a brief description of what you do to accompany each flowchart.
  3. Perform a gap analysis – Assess your system and processes against a standard, checklist, or requirement.
  4. Assess the risk(s) associated with the gaps and prioritize the risks (to each: product or service, process, business, customer, etc.).
  5. Make an active choice – Decide on a mitigation/action plan or document the reasons if no action is planned.
  6. Take action according to your plan.
  7. Determine if the action was effective – Did it have the desired outcome? Does it serve the company’s needs?

Remember, keep it simple or as simple as possible. Begin with what you actually do without trying to mimic language in a standard. Keep in mind that most standards tell you what to do, not how to do it. The “how” is up to you. The “how” should be what you actually do, even if it is not a best practice (yet). Writing something that meets the standard, but does not reflect what you do, will become painfully obvious at the most inconvenient time. That is why so many nonconformance findings result from not following your own processes; because, they are not your processes. And, if your process is not a best practice or a best practice for your business, that will be evident to the organization in the form of poor results, waste, and unnecessary cost, which then can be addressed. So, start with picture – a picture of your system and your processes. Why? Because, it is your system.

A closing thought – Consider calling your system a “business system”, rather than a “quality system”. It is how the business operates, and quality should be an integral part of the business.

Contributed by TDQA Consulting