CAPA and Discrete Manufacturing Process Flow: More Than Just Corrective Action

Corrective action encompasses more than just corrective action; it refers to both corrective and preventative action (CAPA). In the area of discrete manufacturing -- and the automotive industry, in particular -- manufacturers must take specific steps to remedy a problem and to create a process flow. Both CAPA and electronic Failure Reporting Analysis and Corrective Action System (FRACAS) are examples of processes that can play a role in helping to reduce risk of lost or incomplete records and ensuring that manufacturers comply with industry standards in the event of safety failures or subsequent recalls. Although FRACAS typically exists for the purpose of evaluating products before they are released to the consumer public (and can extend long after a project has been completed), both CAPA and FRACAS deal with products during the entire lifecycle.

CAPA only comes into focus after a manufacturer initiates and completes certain other processes -- such as incident intake, triage, containment, investigation, and analysis. Based on these findings, a manufacturer can then decide whether to take corrective and/or preventative action.

CAPA in the Face of the TREAD Act and Recent Automotive Recalls

In 2000, the Transportation Recall Enhancement, Accountability and Documentation (TREAD) Act was passed to help improve safety for automotive consumers. Under the TREAD Act, auto manufacturers must report to the National Highway and Transportation Safety Administration (NHTSA) when they conduct a safety recall, as well as report defects, product-related injuries, and other information. This is done from a compliance standpoint with NHTSA’s early warning requirements. Manufacturers must also allow the NHTSA to collect data, information on trends, and issue consumer warnings regarding any possible safety and operational defects in vehicles.

In June 2014, automotive manufacturer, General Motors recalled a total of 6 million cars of various models, made between the years 2000 and 2014. The recall was issued due to problems with the cars’ ignition switch slipping out of place and causing the engine to stall. This defect caused drivers to lose control of their vehicles, resulting in roughly 54 crashes and 13 deaths. Although GM knew that the issue existed since 1999, the recall was not issued until 2014.

A CAPA system can help manufacturers to comply with the TREAD Act and better the finished product. With a system and defined set of rules in place, details can be compiled into reports based on outcome. For instance, if a product failure resulted in death, reports would take one route. If a product failure resulted in injury to consumers, it would take another path. This does not mean a manufacturer should limit CAPA to external events; as a best practice, manufacturers should adhere their processes when internal testing or data point to probable causes that might lead to safety or operational short fall of their products.

As an example, setting up early warnings at threshold can be useful to those in the automotive industry, particularly with regard to the TREAD Act. A manufacturer can look at normal quality events and set a standard that if a problem occurred more than “x” amount times in a given time period, that it can stand as a threshold.

These defined threshold parameters can also be used as a trigger that can be reported. These triggers can be used proactively in troubleshooting potential problems before a product goes to market.  Additionally, these processes should be set with business rules when certain types of issues resulting in the set threshold should trigger a set of workflow which can alert management. This would prevent subjective decision-making and bring potential early issues to the attention of the upper management for greater visibility and responsible follow-up tasks. Moreover, these automated workflows will track and audit trail every task, electronic approvals through e-signatures and provide complete accountability, traceability and transparency. From a corporate standpoint, this system can be considered as a risk mitigation solution.

However, depending upon industry, many manufacturers do not have the same incentive to set these rules in place earlier in the process. They may have self-informed requirements, but a company’s internal process may be its own worst enemy. The biggest problem is not always a lack of data, but a lack of rules and internal culture.

For instance, the Federal Aviation Administration (FAA) has the authority to revoke a license, certification, or even revoke a standard airworthiness certificate if they deem a manufacturer’s processes and handling of events as unacceptable. When an aircraft type loses the operating certificate, it grounds the airlines’ fleet which is an adverse effect for the aircraft manufacturer. On the flipside, the NHTSA does not have the power to enforce pulling a license or type certificate.

CAPA: Making the Discrete Manufacturing Process Flow More Objective

One of the benefits of CAPA is that it can steer a discrete manufacturing entity toward a greater sense of objectivity in creating an effective process flow. Many industries are making use of root cause analysis tools, such as the root cause decision tree. By using these systems as an aid in the decision-making process based on a defined set of rules, it makes the process more objective than subjective.  Additionally, decision trees are being used to assess risk components and to determine if corrective action must be taken, or if a full CAPA project is required.

Although it is more of a project than a process, 8D has been used by a great many automotive companies for managing corrective action. Originated by the Ford Motor Company and published in 1987, 8D works as something of a more refined and structured CAPA process. It’s important to have a solution to handle different cases and treat them appropriately. An 8D process may be time consuming and in some cases, a far simpler process will yield more positive, direct results in defining and verifying root causes, as well as choosing, implementing, and verifying permanent corrective actions.

Building a Solid CAPA Framework

Some of the other problems faced by manufacturers -- both from an internal and external standpoint -- is that not only do different industries define CAPAs differently, but separate divisions within a singular company can have different definitions, too.

Internally, when a company expands and inherits different systems via M&A activities, it can be like playing baseball with two teams that are playing from two different rule books. Since each company has often invested so much time in compiling data in their own way and in their own system, it can be difficult to synch up information to observe different trends.

If a company acknowledges this problem, a unified quality management software solution such as TrackWise can be of help. Manufacturers can push the information to the system, which helps to solve threshold- and data- issues by standardizing the baseline and process. This is especially helpful when a company has facilities in multiple countries.

However, problem-solving becomes trickier when you deal with external stakeholders beyond your four walls. To push this information to stakeholders and partners, you must have appropriate supplier agreement in place. There may be different agreements in place for Tier 1 and Tier 2 suppliers. With these differing supplier agreements, come different incentives for them to follow. However, by providing system access through cloud based SaaS solution like Stratas, manufacturers ensure that there is no repetitive or redundant info. This gives manufacturers an opportunity for better costs by maintaining supplier ratings at a higher level and giving competition an edge and a way to cut in. TrackWise provides access to these suppliers with relevant security and data so required information and tasks are processed in near-real time for greater visibility, efficiency and effectiveness while reducing overhead costs for both suppliers and the manufacturer.

When everyone involved in the manufacturing process sees value in the process, they can see the incentives in the form of cost reduction and more reliability. This is fundamental to building a solid CAPA framework.

Check out a demonstration of our Failure Reporting Analysis and Corrective Action System (FRACAS) software and see how electronics and high-tech manufacturers can manage product issues efficiently.

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