We wrote this guide to help you better understand what you need to consider when researching quality management software.
Here's what we'll cover:
Quality management software (QMS) can help manufacturers measure (and therefore improve) the quality of their products and processes. This software category can refer to a broad range of applications that help manufacturers ensure quality across all supply chain activities—from design to production to distribution and eventually, service.
Some solutions on the market are created for general repetitive manufacturers, while others are designed for specialized manufacturing (e.g., pharmaceutical and biochemical manufacturers).
The applications that can make up a quality management system aim to help manufacturers better control the four key components of quality management:
Common functionality found in these systems includes:
|Corrective and preventive action (CAPA)||Helps manage and track CAPAs by automatically routing corrective/preventive actions to the right quality manager so they can accept or reject the action. If accepted, the system will assign the action to a responsible party and start a workflow to investigate the root cause of the issue. Quality managers can attach documentation, assign priority to and monitor the status of each submitted action.|
|Audit management||Tracks all audit tasks and documents. Keeps a record of internal and third-party audits, tracks the scheduling and results of every audit and allows manufacturers to evaluate the effectiveness of auditors. An audit management application will usually be built to pass this information to the document control or CAPA modules so that audit information can be attached to the corresponding corrective/preventive action.|
|Complaint management||Helps manufacturers improve their quality of service by logging complaints from customers. Manufacturers can then investigate, respond to and resolve customer complaints. This application can provide manufacturers with useful feedback from end customers that might otherwise be difficult to obtain.|
|Change control||Identifies, defines and organizes the tasks required to implement a change in company processes or use of resources (e.g., packaging for a particular product). The system then analyzes how that change will impact the company.|
|Document control||Helps manufacturer’s organize all documents related to production—from the design files for a product to standards compliance documentation—in a centralized and searchable database. Documents can be easily sent to team members for review/approval and linked customer records, bills of materials (BOMs) and inventory.|
|Risk management||Enables manufacturers to more easily evaluate risk by standardizing risk assessment documentation and analyzing recurring issues in a single location. All risk files are associated with the corresponding document, project or process to improve analysis.|
|Statistical process control||Collects, analyzes and visually displays data from shop floor machines to measure statistical variations in output. Based on this data, manufacturers can fine-tune their production processes to reduce scrap rates, improve yield and produce a higher quality product.|
|Supplier quality management||Helps manufacturers qualify, select and monitor supply chain partners. Includes features for supplier scorecards, supplier qualification workflows and tracking of supplier issues such as non-conformances.|
|Employee training management||Helps manage employee training by tracking training activities and ensuring that relevant course materials are completed. Ensures compliance with requirement for proof of quality management training.|
Prior to evaluating a quality management program, you’ll want to know what type of buyer category you belong to:
Enterprise quality management software (EQMS) buyer. Manufacturers that require data integration across all applications should evaluate an integrated suite. These systems are able to manage quality compliance, track the source of quality issues, monitor shop floor operations and evaluate supplier relationships within a single system. EQMS systems can be integrated with other enterprise applications such as enterprise resource planning (ERP), supply chain management (SCM) and product lifecycle management (PLM) software to provide a more complete view of operational quality.
Single application buyer. Manufacturers that are not ready to purchase an enterprise system may consider a single solution to better manage one aspect of operations. Common applications that manufacturers can purchase on a stand alone basis include document control, change management and statistical process control (SPC) software.
Specialty buyer. Some manufacturers will have industry-specific requirements. For instance, pharmaceutical manufacturers require functionality to prove compliance with the Federal Drug Administration’s guidelines in Title 21 CFR Part 11. This means they need a system that helps properly track plant audits, control for drug quality and track all electronic documents according to FDA standards. Other manufacturers that should evaluate a specialized system include medical device, consumer products and electronics manufacturers.
In addition to the key functionality we reviewed above, there are other capabilities that can be important to quality management, but aren’t present in every system. Here are a couple more to consider before implementing a new system.
Data visualizations. A QMS system collects high volumes of useful quality data. To synthesize all of this information and make analysis easier, manufacturers should consider the visual reporting capabilities of their system as a well-designed reporting dashboard will make it easier for the average user to make more data-driven decisions.
Example of a quality management reporting dashboard from IQMS
Web-based supplier portals. Many systems provide a Web-based portal to manage supplier relationships. These portals give suppliers real-time access to your supply requirements such as purchase orders, payment and invoicing as well as advance shipping notice (ASN) information. This makes it easier to interface with your suppliers and also gather valuable information about suppliers’ performance. Before implementing a supplier portal, it’s important to coordinate with suppliers to ensure you provide them with information they need to meet your inventory needs. Some manufacturers also share their supplier scorecard in this portal so suppliers understand the exact metrics you’ll use to evaluate their performance.
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