Electronic Quality Management Systems (eQMS) for Manufacturing

Manufacturing companies need to constantly stay on their toes to react to the numerous prevailing market forces. If they don’t, their customers can and will often opt for offerings from competing companies. As such, businesses need to ensure that they can satisfy their customers to retain them.

One of – if not the – best way to foster customer retention is to consistently provide the highest quality products, reducing the need to seek out alternative offerings from competitors. For manufacturers, this is where quality management systems come in.

A quality management system is a commonly used tool that allows manufacturers in different industries to document and keep track of processes and procedures used to produce items within their facilities. Furthermore, the system details the company’s policies and internal rules relating to their products, ensuring customers receive exactly what they’re expecting with consistent quality.

In traditional manufacturing settings, businesses often rely on physical documents to manage quality practices. Although this had been considered adequate in the past, the advent of the internet-based systems and tools have rendered paper documentation obsolete.

Not only is paper-based quality management time-consuming, but it also tends to be extremely error-prone. As such, manufacturers have made it a priority to replace their paper-based processes with electronic quality management systems (eQMS) to alleviate the shortfalls of outdated, traditional alternatives.

In this post, we’ll do a deep-dive on eQMS, reviewing the many challenges that come with traditional quality management practices and highlighting the key benefits of digitizing Quality Management Systems.

Although many manufacturers have integrated digital tools into their quality management efforts, there’s still a significant amount of physical documents involved.

As a result, such manufacturers still face many of the challenges associated with managing quality in the production process using paper documents. Some of these challenges include:

• an increased risk of crucial documents getting lost

• the process involved in creating and managing documents is long and laborious, eating up time and resources that could be spent on other productive areas of the manufacturing operation

• a convoluted process to trace and retrieve critical documents and processes

• an increased chance of missing operator, supervisor, and manager signatures on vital quality management documents

• the physically-centralized nature of document keeping makes it hard for other relevant parties from different departments to quickly and conveniently access documents

• based on the above, accountability and traceability are more complicated than they need to be

• quality audits are more complex because of the convoluted information retrieval process

• difficulty in keeping logs, batch records, and history records up-to-date due to the cumbersome process involved in authoring and editing the various documents within the file

• old files and documents can stay in circulation, triggering a cascade of quality events due to obsolete policies, procedures, or product designs

• complicated and ineffective risk analysis and management due to inadequate information availability

With the inefficiency and mistakes originating from traditional paper-based quality management systems, manufacturing businesses stand to run on increased costs due to errors and ill-informed corrective measures.

As a result, such businesses should turn to electronic quality management systems for more comprehensive and effective management of quality processes.

Manufacturers need to maintain a good handle on their quality process to gain a stronger foothold in the market. Quality is an intrinsic requirement for manufacturers in regulated industries like pharmaceuticals and medical devices. And because such fields are closely linked with human health, the margin of error for substandard products is significantly slim.

Consequently, such manufacturing fields have more stringent quality requirements, requiring electronic quality management systems to conform to standards like ISO 9001 and regulatory bodies like the Food and Drug Administration (FDA).

The key benefits making eQMS vital in such sensitive manufacturing situations include:

Better accessibility: Whereas traditional QMS requires personnel to search for a particular document, eQMS allows them to access digital records and information remotely via the cloud quickly.

Interdepartmental collaboration: An electronic quality management system allows relevant personnel from different areas of the organization to access, edit, and contribute to quality documents. This does away with silos, making operations smoother.

Real-time data management: Because the information exists digitally in the cloud, any changes to quality management documents are automatically synced. This ensures that personnel always access the most recently updated information.

Better and more efficient document control: In a paper-based setting, documents can easily get lost. Furthermore, personnel is more likely to make errors when authoring on physical paper. This setting significantly hinders an organization’s ability to comply with standards and regulations.

However, when it comes to an electronic quality management system, vital data can be automatically captured from the shop floor to populate the relevant documents and quality-related databases, eliminating human error.

Traceability and accountability: With an electronic quality management system, manufacturing businesses always have immediate records of any changes to the quality-related documents. As a result, quality managers and risk auditors can access the revision history, tracing the different modifications made.

Additionally, eQMS promotes accountability due to the online system keeping track of – and clearly denoting – the person responsible for the given changes. This is supported by the fact companies add key stakeholders and their roles and responsibilities to the electronic quality management system.

Ultimately, even with a good eQMS, manufacturers should constantly strive for continuous improvement. Modern quality management systems enable manufacturing businesses to instill quality throughout their operations. This ensures that they can take corrective and preventative action without disrupting production significantly, promoting customer satisfaction.

Using Tulip, manufacturers are able to digitize and streamline all quality management processes with apps that help to reduce human error, as well as detect and eliminate the sources of quality issues using real-time data.