Nonconformance 101: the Basics, Challenges & Management of
Companies invest large sums of time and money tracking and managing nonconformances. Though it may seem rudimentary, I’m going to start at the very beginning to explain what a nonconformance is and some common ways in which nonconformances are tracked and managed. I will reference to nonconformances that occur during a manufacturing process (though nonconformance management is common across product, process and service providers). I’ll break out the challenges into a separate section so you can use it as a checklist against your own process. My hope is that this may aid you and your organization on the path of continual improvement; armed with a solid foundational knowledge of what nonconformance management is and some pitfalls to avoid. This is nonconformance 101: the basics, challenges & management of…
Nonconformance 101: Acronyms and the Basics
So, you have a process within your organization to create something GREAT for your customers. You have engineered the product to be ‘flawless’ and the process to make it even more-so. You start production, and what happens?
Something goes wrong!
The occurrence of a problem with a process or product is referred to commonly in the quality realm as a ‘nonconformance’. A process designed to manage nonconformances is what is referred to as nonconformance management (NCM). I use the fully spelled out version because there are about as many acronyms to represent nonconformance management as there are companies that experience nonconformances.
There are four core elements within a nonconformance management process:
- Standard Reporting Method: It is essential for the occurrence of a nonconformance to be tracked in a standardized way. The occurrence of a nonconformance is commonly recorded using a Nonconformance Report or (NCR).
- Nonconformance Review Process: The data from the NCR is then commonly reviewed by a Material Review Board (MRB) to assess the impact of the problem. This board commonly has representation from the Quality, Production, Engineering and Regulatory departments. Generally, many companies will review nonconformances in batches at the end of a day or shift.
- Disposition: This is where it’s decided what is to be done about a specific occurrence of an issue. Examples of disposition types within a manufacturing company include: rework, scrap, recall, Return to Vendor (RTV). products/processes, categories, time periods, and suppliers.
- Ongoing Analysis: Ongoing analysis of trends in nonconformance data gives an organization the ability to make changes to their process to reduce the occurrence and costly impact of nonconformances.
Challenges and Pitfalls of Nonconformances
All companies large and small have to deal with managing nonconformances. The larger the company, the more complicated this process can become. As companies grow from one small team of people to multi-site corporations and continue to expand through acquisition, the processes and data being tracked almost certainly diverges. Suddenly, the process that worked so well at the founding location is not easily adopted at the new locations, and then you wind up with stacks and stacks of nonconformance reports all being measured and managed in different ways.
So when a customer calls and asks if a defective part that they have received has occurred before…well, let’s just say that it’s fire drill time for the quality department. At worst, they will have dozens of filing cabinets at multiple facilities that require picking through to see if the issue has occurred before. I have personally seen organizations spend thousands of hours a year assigning quality engineers to this very thing. And commonly, once they were finished collecting one type of data, they would get another call sending them back to the filing cabinets.
Through the years I have seen many ways of tracking nonconformance data. Here are some points to consider if you are thinking about effectively managing nonconformances.
Start with the end in mind: Define the ways you want to organize your data should management (or a customer) request it. Build the nonconformance report (NCR) with that information included.
Review the NCR form: It is amazing how often we continue to use systems that are in place just because “we’ve always done it that way”. A fresh look at your nonconformance report may illuminate pieces of data that don’t serve a long term purpose, and therefore, can be eliminated.
Standardize Reference Codes: Using checkboxes or selected code values be sure you have a place on your nonconformance form to track:
- The type of nonconformance
- The type of disposition that was decided upon
- Traceability Information: It may seem like a no-brainer but make sure to track pieces of information such as: part number, lot/job #, serial #’s, customer, department found, supplier, quantity of product impacted. These pieces of information are commonly used to look up nonconformance records.
So hopefully this article has helped verify or enlighten your understanding of nonconformance management. I feel that in many ways an effective nonconformance management process/system is the foundation of every other component of the quality system. Once you have a good handle on occurrence tracking then things like metrics and Corrective Actions become much easier to define and manage. There is always the use of nonconformance management software to help you control the process. Until next time, keep up the quality work.
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