QUALITY MANAGEMENT SYSTEM

What is a Quality Management System? Why is QMS important?

A traditional Quality Management Software (QMS Software) program is a database or electronic repository, where all the quality related files and records of a company are stored. The software provides tools to help the company achieve the quality related requirements of their customers work and meet regulatory requirements for quality management.

However, modern QMS Software systems are much more than an electronic repository because it also allows the automation of the quality assurance process by automating quality processes and notifying management of changes in real-time. The data can be entered manually or automatically based on the needs of an organization.

There are many ways QMS can help a company achieve quality assurance objectives. For instance, it can help develop certain benchmarks to achieve QA goals or it can be used to streamline production. Companies have also used paperless QMS to reduce paper waste and improve the manufacturing process.

What are the benefits of a Quality Management System (QMS)?

A good QMS Software will allow managers to keep track of the company procedures and quality processes for compliance to standards such as ISO 9001, AS9100, ISO 13485 and many other, while also recording and helping to improve more tactical quality assurance processes such as First Article Inspection Reports (FAIR) as well as in-process dimensional inspection reports of jobs or work orders on the factory floor. Some of the records that can be maintained using QMS include:

Outlining specific procedures to understand and improve quality business process guidelines within the manufacturing environment.

Keeping record of training sessions and documentation to train employees for easy tracking and auditing.

Calibration and maintenance of company equipment and measuring instruments and gages.

Reductions in scrap rate, based on Real-time tracking of dimensional inspection reports are saved in QMS software.

Non-conforming material and documentation tracking to alert the management of impending issues and problems.

Corrective Action Request tracking to provide closed loop systems to improve company processes and update documentation and procedures based on specific guidelines embedded in QMS.

Supplier quality management by keeping track of the supply chain and its stakeholders.

Tracking Return Material Authorization (RMA) when a client needs to return a potentially discrepant product.

What are the main functions of QMS software?

Regulatory Compliance

Document Management

Employee Training Records

Non-Conformance Report Tracking (NCR)

Corrective Action and Preventive Action (CAPA)

Vendor Quality and performance tracking

Continuous Improvement

Calibration of precision instruments and gages

Audit Management

Risk Management

How can QMS effectiveness be measured?

QMS can be measured by the continuous improvement of quality metrics, the cost of quality, and the time that it takes to manage the quality related systems and processes of an organization. Effective QMS software should help to maintain the overall quality system or business management processes within the organization, with as little overhead cost as possible. It should also help improve the frequency, and cost of non-conformances and the need for corrective action both internally and externally with vendors or approved suppliers.

How can QMS effectiveness be measured?

The following seven Quality Management Principles (QMPs) have been established by industry experts across the world who contribute to the ISO standards which is the most widely recognized international organization for establishing quality management standards:

QMP 1 – Customer focus – Ensuring customer satisfaction.
QMP 2 – Leadership – Ensuring alignment at all levels of the organization towards quality objectives.
QMP 3 – Engagement of people – Engaged employees are the foundation of quality.
QMP 4 – Process approach – Core quality processes are fundamental to a quality product and service.
QMP 5 – Improvement – The most successful companies are always focused on improving their processes an products.
QMP 6 – Evidence-based decision making – Ensuring customer satisfaction.
QMP 7 – Relationship management – Collaboration with clients and vendors is essential to a high quality value stream.

How does QMS help ISO9001, AS9100 and ISO 13485 certification?

The standards listed above, and others, are put in place to establish an internationally recognized methodology for manufacturing companies to create quality policies and procedures to ensure high quality and continuously improving products and services. The ISO standards, established by the International Standards Organization and AS9100 which is published by the Society of Automotive Engineers specifically for the Aerospace industry are the benchmark which manufacturers need to follow to be recognized as world class manufacturing companies.

QMS software is essential to being able to meet the stringent quality requirements of these standards. Many companies choose to manage their quality systems with a network of file folders on their computer network, filled with documents, forms, and records that are required for meeting the above standards. Some companies even still choose to manage their quality system processes largely with paper documents which are stored in filing cabinets. While it is possible to meet the requirements using these methods, the overhead cost of doing so, and the chances of errors and out of date information is enormous. Companies who manage quality this way have considerably higher cost of compliance to the standards.

QMS software can dramatically reduce the cost of compliance, the amount of time and overhead burden required to stay in compliance, pass audits, reduce risk, and generally manage the Quality Management Systems of the company. Cloud based QMS software especially, can be used very efficiently to ensure that overall quality and compliance to the standards are met with the minimum of cost and work. The software is always available, it’s easy to access, always on the latest version, and can provide a single source of truth as it relates to quality data.

Is QMS made for medium and large companies only?

QMS software should be used by any company who is focused on building high quality and services based on the principles of continuous improvement, risk management and quality assurance. It doesn’t matter what the size of the organization is. Even small companies can benefit from using QMS software to reduce the cost of quality management. Whether or not a company is trying to become certified to a standard, or just wants to have excellent quality within their organization, QMS software can be the most effective way to ensure that client satisfaction and the resulting financial success is at the core of everything a company does.

How does QMS integrate with ERP? How are they related?

QMS and ERP (Enterprise Resource Planning) software are often sold separately and are not well integrated. This situation can cause considerable labor expense, risk of errors, manual duplication of data entry and lots of frustration with a company.

In an ideal case, the QMS and ERP software should be one and the same, and deeply integrated together with no real distinction between them. All the quality related processes are based on and connected to much of the data within the ERP system, so they should be well integrated to eliminate duplication of data. The types of record control needed to show companies are in compliance with quality standards reside in the ERP, such as clients, work orders, vendors, work cells, employees, machinery, inspection gages and instruments and more. With a well integrated ERP and QMS, all this data can be automatically propagated into the relevant QMS forms such as NCRs, CARs, RMAs, etc. This allows very easy auditing and querying to take place so the best decision can be made in regards to continuous improvement and client satisfaction. When data is siloed in separate systems, the opportunity to leverage the data is significantly reduced and therefore isn’t done as often, which can reduce the overall performance of the company.

What do QMS systems have to do with MES systems?

QMS and MES (Manufacturing Execution Systems) should be well integrated to achieve the best operational performance on the shop floor. MES software helps to improve overall efficiency on the shop floor, and as such, should be deeply connected to the QMS and QA data so essential to effective manufacturing processes. For example, a work order can have visual work instructions, tool lists, and more which are traditionally information kept in an MES system, but the inspection plan and inspection data should be well integrated as well, which is traditionally QMS software. By combining them together seamlessly, the shop workers will have everything they need at their fingertips in a single system to do their jobs most effectively.

What do I need to look for when buying a QMS system?

The right QMS software for any particular organization will be different depending on their specific needs. The first step is to ensure that the QMS software has all the functionality you need to effectively manage your quality processes in a cost effective manner. The second step is to see how well integrated it is into the other software functions such as ERP, MES, CMMS (Computerized Maintenance Management Systems). Keep in mind that a QMS can seem fully featured, but if it isn’t well integrated into the other software systems a company needs, the cost to maintain it will be significantly higher. Lastly, look at the company behind the software. What experience do they have actually running a quality centered manufacturing company? Have they been in the trenches running manufacturing companies? Or is it a group of software developers who think they know what a manufacturing company needs for quality management? These answers can reveal significant differences between the usability of the software solutions you may be reviewing.

What do I need to look for when buying a QMS system?

The right QMS software for any particular organization will be different depending on their specific needs. The first step is to ensure that the QMS software has all the functionality you need to effectively manage your quality processes in a cost effective manner. The second step is to see how well integrated it is into the other software functions such as ERP, MES, CMMS (Computerized Maintenance Management Systems). Keep in mind that a QMS can seem fully featured, but if it isn’t well integrated into the other software systems a company needs, the cost to maintain it will be significantly higher.
Lastly, look at the company behind the software. What experience do they have actually running a quality centered manufacturing company? Have they been in the trenches running manufacturing companies? Or is it a group of software developers who think they know what a manufacturing company needs for quality management? These answers can reveal significant differences between the usability of the software solutions you may be reviewing.

How do QMS systems save you money?

At the end of the day, manufacturing companies such as machine shops, job shops, and other contract manufacturers need to focus on making high quality products with the minimum of cost to meet or exceed customer quality requirements, delivered on-time. Quality problems in the manufacturing process can significantly hamper those efforts and drive up the cost of manufacturing, causing delays in production which results in late deliveries and unhappy customers. QMS Software can help improve quality, reduce overall costs and save money so the objective of delivering quality products at a low cost can be achieved. It can also dramatically reduce the cost of compliance to standards such as ISO 9001 and AS9100 which may be a requirement to do business with the types of customers that manufacturers want. By saving money both on the shop floor and at the high level of the QMS, a shop can focus on the direct manufacturing process with a minimum of overhead which will positively affect the bottom line, allowing profits to be reinvested to grow the company.