Quality is a strategy that must be pervasive throughout every department and every level of the organization. In business, engineering, and manufacturing, quality has a pragmatic interpretation as the non-inferiority or superiority of something that aims at satisfying customer expectations.
What is Quality for Manufacturing?
manufacturing quality is conformance to specifications. Quality of design and conformance to specifications provide the fundamental basis for managing operations to produce quality products. As customer expectations have risen over time, manufacturing quality has come to be an absolute requirement, regardless of where products are manufactured, distributed, and sold. Assuring manufacturing quality entails three principal functions: quality design and engineering, quality control, and quality management.
The cost of poor manufacturing quality is high. Rework, scrap, product failures, and recalls can severely damage a manufacturer through inefficiencies, delays, direct costs, customer dissatisfaction, and low shareholder confidence. Today manufacturers must build products on time, first time, and every time to achieve and maintain competitive standing in global markets.
Some outsource manufacturers miss seeing the importance of having a quality management system (QMS). It is usually due to the old mindset is that investing in quality activities is not a priority and money should go elsewhere.
In manufacturing, the focus is often on reducing costs rather than on improving quality. Research proved that companies that focus on reducing costs increase their costs and reduce their quality over time, while those that focus on quality reduce costs and increase or maintain higher quality standards.
We will discuss below the reasons why manufacturers should invest in QMS.
1- Ensure Compliance
Most industries from medical devices to automotive to F&B have mandatory compliance requirements from various government agencies, and all companies have customer requirements they must comply with. In most cases, the manufacturer must be able to show detailed compliance records quickly, accurately, and consistently. This process can be extremely time-consuming when working with paper systems or even spreadsheets. QMS enforces compliance with procedures, ensures accuracy, and promotes shared responsibility for compliance and quality.
Companies that don’t worry about quality until the end of the production process have higher rework rates than those that build quality into their strategy and processes. The companies that don’t build quality into their processes don’t discover production issues until the product is complete, when they may have to rework an entire lot. This is also the most expensive point in the cycle to do rework, since it may require undoing work done in several operations downstream from the problem step. By focusing on creating processes that produce quality output, companies can act as soon as those processes begin to veer off course. A QMS system helps ensure that process monitoring occurs and provides mechanisms for corrective actions. A QMS system that includes Advanced Product Quality Planning (APQP) capabilities goes a step further by creating products and processes designed for quality results.
Scrap and rework can make up a big part of a product’s cost. Any action that works to reduce or eliminate issues that allow manufacturing non-conforming products will automatically reduce costs. A QMS helps eliminate both scrap and rework by helping to ensure that the entire organization stays focused on producing quality products. When margins are as thin as they are in the contract manufacturing industry, even small savings per unit can make all the difference to profitability.
It’s easy to compete by offering the lowest price, but it’s hard to stay in business for long with that strategy. Focusing on quality is a sustainable competitive edge that enhances your status as a supplier and makes it easier to command premium pricing.
Competing on quality doesn’t mean that your product exceeds the required specs. It means you consistently meet those specs and deliver on time. QMS helps by ensuring that your processes promote quality performance. They enable anyone on the team to call attention to quality issues, and they help promote a quality mindset throughout the organization.
5-Reduce Costly Errors
QMS systems include capabilities for tracking training, so you know your operators have the skills necessary to complete their assigned tasks. They also include document management so that you can ensure that the team works with the latest specs and process directions.
Many industries, especially contract manufacturing, have frequent engineering change orders that affect work in process. QMS software ensures that the latest revisions and documents are available. With paper-based systems, people often pull old routings or marked-up drawings from their files. There is no easy way to ensure people work to the right set of specs—except for an integrated QMS solution.
Regulated industries such as medical devices, pharma, and food and beverage are subject to periodic surprise audits. The surprise factor leaves no time to catch up on the filing backlog or to synchronize spreadsheets. QMS software has audit management capabilities built-in, and you can rely on the audit trails and compliance protocols to produce consistent reports quickly, helping you to ace the audit.
People don’t think of quality as a revenue driver. They are more likely to consider it a cost — but it does drive revenue. A QMS solution helps ensure that you have healthy margins for the incremental revenue by eliminating non-value-added activities, reducing errors, and controlling costs. Consistent quality and delivery performance make your company a more desirable supplier, making it more likely that customers will place future business with you.
Quality is everyone’s responsibility as it measures the output of a company, not an individual.
Now that you have learned about the reasons why manufacturers need to invest in QMS, learn about the Importance of advanced QMS in the pharmaceutical industry.