Learn More About Quality Management Systems (QMS)
What is Quality Management Software?
A quality management system (QMS) streamlines the supply chain by maintaining the main components of quality assurance processes. These components include quality planning, quality control, quality assurance, and quality improvement. This allows businesses to improve the quality of business processes by providing a more efficient system for supply chain quality activities.
Quality management helps companies automate quality compliance processes and align them with industry standards, regulations, and customer requirements. While this type of software usually focuses on product quality, some vendors also provide features to automate quality control for professional services companies.
What Does QMS Stand For?
QMS stands for quality management system, sometimes referred to as enterprise quality management software (EQMS).
What Types of Quality Management Software Exist?
Quality management software can be delivered as a standalone product or as a module of another software such as ERP systems or environmental, quality, and safety management.
A QMS is used across various industries, including manufacturing, IT, automotive, medical, food, and various service industries. Each industry has a standard management system which signifies that a company maintains a quality standard for its industry. A few examples of industries with distinctive quality standards are:
Automotive: The international automotive task force has developed its own QMS that applies explicitly to the automotive industry. This QMS focuses on areas such as car safety, warranty management, and car material waste reduction.
Medical QMS: The healthcare industry developed a QMS that has standardized requirements for medical devices. This helps with the design, production, installation, and servicing of all medical devices.
Food: The food industry has developed a standardized QMS that attempts to combat food safety hazards within the food chain. Having a certified food QMS in place communicates to customers that the ingredients going into their food are safe and of a high quality.
What are the Common Features of Quality Management Software?
The following quality management functionality can help users define, implement, and monitor total quality management activities:
Document control: Often, businesses need to maintain a repository of documents that house best practices and procedures. A QMS can help centralize important documentation that allows workers to access essential business processes and procedures. This helps to promote collaboration, improve decision making, and ultimately save workers' time.
Risk management: QMS allows users to evaluate risk by standardizing risk assessment documentation. This provides procedures, instructions, and records for any risk management.
Inspection management and internal audits: QMS allows businesses to conduct internal audits seamlessly. Within a QMS, users can schedule audits and alert the appropriate workers to complete audits promptly. A QMS can also store audit forms and create reports that analyze audit data.
Corrective and preventive action (CAPA): CAPAs can help provide a structure for what is at the core of a business' inefficiencies. A QMS helps manage and track CAPAs by automatically routing them to quality managers, who can quickly construct a workflow to promptly identify the issue's leading cause. Over time, data collected can be analyzed to determine process improvement areas, such as equipment or materials changes, process redesign, or safety initiatives.
Change management: Quality management software can make change management more efficient and streamlined within a company. With a change management feature, users can summarize what change is occurring within their business and then create the necessary action plans. This helps users determine the impact of a particular change and provides workflows for all teams that need to make necessary changes.
Compliance: Companies need to track regulatory compliance related to quality management for their business. Since regulatory requirements can vary by industry or location, businesses use quality management software to identify and monitor laws and standards applicable to their operations. There are also industry standards established by organizations such as the American Society for Quality, the International Organization for Standardization, or the Food and Drug Administration (FDA) agency in the US.
To ensure compliance with regulations and standards, QMS software includes features for:
- A repository of compliance data that is updated regularly to provide the latest information and document changes
- Quality policy management defines and implements work procedures and processes compliant with standards and regulations
- Auditing functionality to identify nonconformance or outdated policies and procedures for quality control
Other Features of Quality Management Systems (QMS): Assessments Capabilities, Certifications Capabilities, Supplier Evaluation Capabilities, Workflows Capabilities
What are the Benefits of Quality Management Software?
Implementing QMS is one of the best ways to ensure continuous improvement of the quality of a company's products and services. Users should think of a QMS as a one-stop shop for quality assurance resources and as a way to enable efficient reactions to any opportunities and obstacles that employees may encounter.
Improved documentation: One of the most significant benefits of implementing a QMS is improved documentation of all business processes and procedures. Having all the critical documents in one location enhances visibility and helps mitigate potential risk.
Unified procedures: Having a central location for quality management helps define company standards and establishes how each work process is performed to fit within the business's quality system. Since each company has its own set of documentation, values, and compliance, there must be one unified quality system that establishes how each action fits within the structure of the business.
Maintain strong customer relations: A QMS allows companies to update best business practices that directly correlate to customer demands. Whenever a business identifies consistent customer complaints, users can update procedures accordingly. This results in higher customer satisfaction and improved business retention.
Save time: Ultimately, a QMS is meant to maintain a consistent business practices approach across a company. This means maintaining consistency in project activities, which will improve the use of resources and time within the company. Quality management software can help companies save time on various activities such as new product development, manufacturing, and maintenance.
Who Uses Quality Management Software?
Quality management software is mostly beneficial to the following personas:
Quality control professionals: The quality assurance team members need QMS software to stay up to date with the latest changes in regulations and define and implement quality control processes. They also use QMS to track these processes' implementation in other departments, such as production and product development.
Production managers: This software type helps production managers implement and monitor quality procedures during all the manufacturing activities. Quality processes can vary significantly depending on the type of product.
Product development teams: QMS data can help develop new products and improve existing products. Historical data provides insights into a product's pros and cons from a quality perspective, which helps product managers develop better products.
What are the Alternatives to Quality Management Software?
Alternatives to quality management software can replace this type of software, either partially or entirely:
ERP systems: ERP systems can only replace quality management software when they provide all or most quality assurance features described above. ERP solutions that only include limited functionality, such as inspection management, cannot fully replace quality management software and should not be considered as alternatives.
Environmental, quality, and safety management software: This type of software combines functionality for quality management and environmental, health, and safety (EHS) modules.
Software Related to Quality Management Software
Related solutions that can be used together with quality management software include:
Product lifecycle management (PLM) software: PLM software manages data during the development of a product from inception through the manufacturing, servicing, and disposal process. In essence, a PLM is closely related to a QMS since both software deal with streamlining business processes and making the production process more efficient. While a PLM can help manage production data, a QMS can facilitate more corrective and preventive actions to ensure that the data is accurate and complies with standard requirements. Integrating the two can help improve the design and production monitoring.
GRC platforms: GRC platforms help companies ensure compliance with many regulations, standards, and internal policies. While this type of software can manage documentation on quality requirements, it does not provide the features to define and implement quality control activities such as inspection and corrective actions.
ERP systems: Production planning and scheduling are done using ERP systems, but this software type doesn't always include functionality for quality control. Even when ERP provides quality management modules, they may not be enough for complex operations and highly regulated industries.
Manufacturing execution system (MES) software: MES helps manufacturers monitor quality on the shop floor. Manufacturers use QMS to define quality assurance procedures deployed on the shop floor using MES solutions. MES monitors production in real time and provides quality metrics used by quality managers to identify nonconformance.
Challenges with Quality Management Software
Quality management software can come with its own set of challenges.
Over documenting: Many organizations that implement quality management software go overboard with documentation regarding best business practices and procedures. This leads to some QMS having multiple documents for one method, which can confuse employees and mislead them. To combat this issue, companies must make sure that the QMS is consistently checked for duplicate documentation.
Outdated documentation: Many organizations that implement a QMS don’t always update documentation regarding best business practices and procedures. This leads to some QMS having outdated quality data, which can be misleading for employees. To combat this issue, the QMS should be consistently checked for new changes to regulations and procedures.
Business process reengineering: A QMS cannot be very efficient unless users follow detailed and consistent business processes. Ideally, companies implementing quality management should review their operations to ensure that they are optimized to provide the best possible quality and comply with regulations. This requires extra effort and investment and may be overlooked by buyers, creating bottlenecks and inconsistencies that the software cannot solve.
Which Companies Should Buy Quality Management Software?
Quality management is essential to all businesses but critical to the following types of companies:
Manufacturers: Product quality can be an essential competitive advantage in manufacturing, especially in industries like consumer goods, where many companies are making similar products. An increasing number of consumers prefer to pay more for better quality, and manufacturers need quality management software to meet their customers' expectations. Even companies that focus less on quality and more on cost reduction still need to comply with quality regulations to avoid fines or legal actions.
Heavily regulated businesses: Companies in some sectors face more stringent regulations because their activities may put at risk the health and safety of their employees, customers, and the public. A few examples are oil and gas, mining, construction, healthcare, chemicals, and food or beverage industries.
How to Buy Quality Management Software
Requirements Gathering (RFI/RFP) for Quality Management Software
Requirements for quality management should focus on each buyer's specificity, such as their industry or the type of product they manufacture. For example, food manufacturing requires advanced quality control because the wrong mix of ingredients may cause serious health issues. Quality requirements can also vary depending on the type of operations, such as product development, production, storage, and logistics.
Global companies need to comply with regulations that apply to their locations and markets where they operate. While some industry standards are enforced globally, others are specific to a particular continent or country.
Compare Quality Management Software Products
Create a long list
There are dozens of QMS solutions, and a long list can be created by eliminating those that are not a good fit for the buyer. For instance, a healthcare company won't benefit from QMS software that focuses on manufacturing or oil and gas. Other criteria to eliminate vendors from the selection process are their geographical presence or the software delivery model (cloud vs. on premises).
Create a short list
To create a shortlist, buyers need to eliminate more vendors from the long list, which requires further information. The requirements list mentioned above is usually sent to the vendors from the long list, who provide details on how they support each criterion. Vendor responses are compared by buyers, which allows them to choose the best options.
Companies must clearly understand how quality management functionality is delivered. Features can be included in the system, provided through integration with other solutions, or may require customization and changes to the software's source code. Critical functionality such as inspection management and corrective actions must be delivered out of the box (included in the system's standard version).
The cost of the software and related professional services can also be a criterion used to create a shortlist but should not be the most important. Buyers need to avoid sacrificing functionality or services to save money.
Conduct demos
The shortlist products usually provide similar features, and buyers need to see live demos of each product to validate each solution's capabilities. All demos should follow a predefined script that simulates the buyer's most important quality control activities.
It is also essential to focus on regulations or standards critical to the company, such as FDA requirements for food processing companies or ISO 13485 for medical device manufacturers.
Selection of Quality Management Software
Choose a selection team
The selection team should include quality managers, compliance specialists, and product development team members. External consultants are often involved because of their expertise in a specific area or industry, such as manufacturing or supply chain.
Negotiation
While software pricing is a vital negotiation factor, it is preferable to compare the costs and the benefits of the software. Instead of getting a discount on software licenses, buyers should negotiate for advanced features that are not included in the standard system, such as predictive quality analytics or extended services such as unlimited support and training. These will allow the company to better support its employees involved in the quality assurance processes and improve customer satisfaction by delivering better products and services.
Final decision
While executives often make the final decision, this should be a team effort, and managers need to make sure that the employees are aware of the software's pros and cons. User buy-in needs to be achieved before the final decision, not during the implementation.
What Does Quality Management Software Cost?
There are two types of costs related to quality management software:
Direct costs: This includes software licenses, training, implementation, and consulting services offered by the vendor.
Indirect costs: These costs pertain to the costs involved in training employees to familiarize them with the regulations and standards that the company needs to comply with. Companies may also need to hire new employees with extensive experience using the software or a similar system.
Return on Investment (ROI)
The main benefits of using quality management software are twofold:
- Savings realized by reducing defects and avoiding fines and penalties for nonconformance
- Increased sales and customer retention by providing reliable products and services
To calculate the ROI of the software, buyers need to estimate the financial value of both costs and benefits. For instance, the cost of hiring a quality manager can be $100,000 per year. A company that manufactures goods worth $1,000,000 every month and reduces its defects by 5% will save $600,000 annually.
To achieve positive ROI, the benefits' financial value should exceed the costs of using the QMS.
Implementation of Quality Management Software
How is Quality Management Software Implemented?
QMS implementation complexity varies depending on the company's size, industry, and the type of products and services it provides. Small businesses with standard quality control procedures tend to implement QMS themselves, with the vendor’s help. Medium and large companies are more likely to work with a dedicated project manager from the vendor, which may slow down the implementation process but increases its chances of success.
Suppose the buyer is also replacing other related solutions like ERP. In that case, it is essential to synchronize both systems' implementation to ensure they are compatible and quality management processes are consistent across all systems.
Who is Responsible for Quality Management Software Implementation?
The implementation of QMS is planned and executed by the buyer with the vendor's support or one of its partners. Medium and large companies can benefit from having a dedicated project manager for the implementation and sometimes work with external consultants with extensive quality management experience.
The execution of the implementation plan involves all members of the quality control team and other departments that may benefit from using the system, such as production, logistics, and product development. The employees who were part of the selection process should also be involved in implementation since they are already somewhat familiar with the new system.
What Does the Implementation Process Look Like for Quality Management Software?
The implementation process should review and improve the processes and workflows related to quality assurance. This will impact all other phases of the implementation, as follows:
Data migration: Migration of data from legacy systems and other data sources should focus on the needed information for the new or improved processes. Outdated historical data and obsolete procedures should not be transferred to the new system.
System configuration: This is about adapting the QMS solution to the company's processes, not the other way around. While QMS provides standard features for functionality like inspection management, buyers often modify them based on their workflows.
Training: Training should not focus exclusively on features and how functionality helps users improve quality and collaborate with other departments such as sales.
Go live: The go-live should not happen until all quality control processes have been clearly defined, and the system configured accordingly.
When Should You Implement Quality Management Software?
There is no perfect timing for implementation, but buyers should avoid peak seasons when it may significantly disrupt their activities. Implementation should be planned months in advance to allow time for data migration, integration, and training.
When buyers also plan to implement other related software such as ERP or EHS, it is preferable to implement all systems simultaneously. If this is not possible, companies should synchronize their plans to implement multiple software solutions and review business processes across multiple systems.
Quality Management Software Trends
Sustainability
Quality management software is focusing more on improving sustainability practices. This includes improving ways that companies can reduce waste and their carbon footprint. The overall goal is to reduce the human impact on the environment and practice better corporate social responsibility.
Social media
Quality management software are mining more and more customer data from social media sites and incorporating them into their QMS. This allows companies to see mentions about their products and what customers are talking about, thus helping them meet customer expectations and improve their products.
