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Chuck Olinger


Let Your ERP Build a Pathway to a Successful QMS

Many requirements for quality management can be met through advanced ERP software

Published: Tuesday, July 13, 2021 - 11:03

Most manufacturers want a quality management system (QMS) to meet strict quality values. They need one to expressly meet the needs of their specific organization yet be within the parameters of federal, state, and industry prerequisites.

For example, food, drug, and medical device companies all face many of the same regulatory standards, needing wide-ranging quality controls. But in some cases, countries and even states have different types of reporting schemes. The regulatory agencies not only need the data, but they also want it in the format that they dictate. How it gets reported in Maine can be different than in Spain.

So, to meet standards in their various regulatory constituencies, such products must ensure quality control, standardized testing, quality assurance, and compliance with common industry and well-established regulatory standards. There needs to rigorous testing to make sure the product is safe for humans to ingest and distributed at the correct strength to meet desired outcomes.

Most companies have found that meeting these requirements has become more perplexing than ever because of globalization and outsourcing. Nonetheless, ensuring quality means an organization must have a strict supplier selection process, quality agreements, special raw materials examinations, and consistent overview.

How enterprise resource planning (ERP) yields quality management

What do we mean by quality management? Does it react to challenges inherent to historical approaches? How can companies use ERP to get quality management to perform, even if they don’t have the resources for an enterprisewide implementation that includes a QMS?

First, we typically agree on points where quality must be included as part of our normal business practices, whether engineering, inventory management, or customer service. For instance, don't you already check when customers complain or if your product goes through a design change? What if the problem emanates from a failed part or ingredient? Don't you track back to see where that part or lot came from, and which customers could be getting products containing those parts or ingredients from the same batch? Typically, finding answers to such quality problems will emanate from your ERP.

It’s likely that your ERP is also tied into your customer service system. If there is a complaint, what happens? Is the issue documented quickly? Is it documented properly? Could you discover its source? The track-and-trace attributes of your ERP should be of great help in reporting what has happened to inquiries of each governing body, including agencies such as the U.S. Food and Drug Administration (FDA).

The point of all this is that most companies tend to implement ERP first. After all, most of the regulations for a quality system focus on manufacturing operations. For instance, more than 75 percent of the FDA quality system regulations and ISO 13485 requirements pertain to processes and procedures for production and post-production activities. Thus, companies must develop an effective quality system using their ERP.

With their ERP, these companies have moved away from their disconnected silos of information and inefficient interactions with suppliers, production, quality management, and customers. The enterprise cloud platform is beginning to support all of a company’s needs. To be clear, this is not an enterprise cloud platform that is advertised and offered via a television commercial. It is a platform that would include at least ERP, customer relationship management, QMS, and field service attributes. Of special importance, the ERP could track and trace product histories, provide lot control, and improve efficiencies through automation, especially with engineering, inventory, and production management.

Other benefits the ERP provides

Quality departments aren’t left naked with only their new ERP. To the contrary, the ERP establishes defined control procedures by capturing design changes and ensures that such changes continue to meet what the user needs while keeping the product safe and effective. Design documentation and records are kept as part of design history.

By documenting clinical validations performed on production units, lots, and batches, any results leading to design changes can be tracked along with production process modifications. If a clinical validation needs to be repeated, the ERP tracks those results as well.

Going a step further, if a change is made in the design of a product, there most likely will be a corresponding change in its manufacturing. With an ERP, all such required changes are immediately shared with all departments to limit delays and cut prospective production costs.

Thousands of documents, including SOPs, work instructions, and policies can be saved by the ERP, and so can records of corrective and preventive actions. By having a reservoir of such information, the company can show the quality of its products, processes, service, and compliance to laws and regulations.

Does your product have to meet the requisites of the FDA or ISO? Then, you must follow their guidelines, including printing lot numbers and expiration dates on all packaging. Your ERP will keep this information so you can double-check for expiration date, updated quantities, and inspection results.

An ERP will even track products “as designed,” “as built,” and “as maintained in the field,” including serial numbers and revision levels of subcomponents, such as software components. It also provides visibility up and down the company’s business to connect demand forecasts back to supplier purchase orders, so a company is always keeping pace with production needs and customer expectations.

As you know, adding a new supplier is always a risk. Can this new partner provide you with audits and timely change notifications? Your ERP can track these data and provide online access to suppliers to provide real-time inputs.

When you finally add your QMS

There is no question: In a perfect world, your new system will include a QMS. Your ERP can help make such an addition easier. Ultimately, when you add your QMS, it will streamline quality, compliance content, and collaboration management across your diverse, globally-based supply chain. Being on the same cloud platform, the QMS would integrate seamlessly with the ERP, and the company could ensure safety and compliance with its many regulations.

As we have seen, many requirements for quality management can be met through advanced ERP software. However, eventual integration of ERP and QMS will enable you to have a single platform for visibility into your quality, production, supplier management, and field service processes. You will be able to make optimal decisions by leveraging the most current data.

Make sure that the ERP and the QMS you select will provide your company with a total digital approach. That way, you will create an enterprisewide state of control and predictable quality, while ensuring that regulatory and product safety requirements are fully met. You will reduce the cost of compliance and fully meet the expectations of your regulatory agencies and customers.

With a single integrated solution, you will avoid startup fiascoes, and your company will end up with greater visibility into its entire operation.


About The Author

Chuck Olinger’s picture

Chuck Olinger

Chuck Olinger is the Senior Executive Vice President for Rootstock Software. Olinger directs Rootstock’s strategies for growth while expanding customer and partner relationships. With over 35 years in the development, sales, marketing, and implementation of manufacturing systems, Olinger provides extensive knowledge regarding today’s market and current buyer trends.