In manufacturing, producing quality products is everything. Manufacturers who don’t produce products of sufficient quality will quickly find themselves shut out of a supply chain. Meanwhile, a commitment to product quality can result in fruitful buyer relationships that lead to a steady stream of reorders—in other words, the best kind of sales relationships.
Manufactures practice quality assurance—providing confirmation of their product quality to regulators, wholesalers, retailers, and consumers—by implementing a quality management system (QMS). From the QMS, the companies develop quality controls, steps that reduce risk and identify points of potential quality failure to shore up.
Manufacturers interested in upping their product quality—or just starting in the business—have several options to consider for their QMS, but three key practices usually need to be implemented.
There’s a reason they call it a “supply chain.” From the raw materials to the finished product, a product has numerous stops to make, hands to pass through—in other words, links in the chain. We know what they say about chains—they’re only as strong as their weakest link.
It’s a manufacturer’s job to make sure that the links in the chain that precede them are strong. Otherwise, even the best manufacturing practices can’t guarantee product quality.
The process to screen suppliers and contractors is called a supplier audit. Some supplier audits focus on the environmental impact, the human rights impact of the supplier’s processes, and the supplier’s lack of involvement in terrorism. Many companies care deeply about all three of these principles! But the supplier audits that most directly impact quality assurance include:
A quality systems audit (QSA) is an audit that assesses a supplier’s internal quality controls and production capability. Without a confirmation of supplier quality, it’s impossible to know whether a supplier will leave you high and dry. This kind of audit is especially important for manufacturers who work with foreign suppliers.
The most common QSA is an ISO 9001 audit. ISO 9001 is an internationally-accepted quality standard issued by the International Standards Organization. Variations on the standard include AS9100, a version of ISO 9001 adopted for the aeronautics industry.
While companies may be certified as ISO 9001-compliant, don’t leave it at that. ISO certificates can be falsified, and quality standards can experience steep drop-offs. Manufacturers should consider contracting an ISO-qualified auditor to confirm compliance.
The audit covers:
- Basic maintenance of equipment, facilities, and environment.
- Quality controls on incoming materials.
- QMS organization.
- Production controls.
- Finished good controls.
- Recruitment and training of employees.
- Behavior management and business development.
Good manufacturing practice (GMP) audits are necessary for suppliers of certain sensitive materials, including:
- Food and beverage consumables.
- Medical devices.
- Veterinary supplies.
Whereas ISO 9001 audits evaluate a supplier’s ability to meet its obligations, GMP audits add an additional layer of safety auditing in evaluating supplies for sensitive, heavily regulated products.
To the usual retinue of controls, GMP audits add:
- Packaging and labeling.
- Storage, warehousing, and distribution.
- Equipment and utensils.
- Production and process controls.
Product testing is a fact of life in the manufacturing industry, but one test is never enough. Quality assurance involves a constant cycle of testing, testing, and testing again. Moreover, the same testing procedures must be followed every time in order to ensure actionable results.
The point of a product test is to verify performance, uncover defects, and take corrective action to address defects. Manufacturers can come at this process in two ways:
- Design Test. Verification that no faults exist in the design—a thorough evaluation of the product specifications and the soundness of the engineering.
- Manufacturing Test. Testing of the finished product that comes off the line. Manufacturing tests might evaluate the product for structural soundness, conformity to design specs, and safety/health hazards.
Every experienced manufacturer knows that suboptimal environmental conditions lead to suboptimal products. Monitoring and controlling the environment of the production facility is critical to ensuring product quality.
Factors that need to be monitored in most factories include:
- Ambient temperature.
- Ambient humidity.
- Temperature of materials.
- Temperature and pressure in fuel tanks.
- Voltage running through machinery.
- Stress pressure on materials and machines.
Most manufacturers monitor these conditions using digital data loggers. Placed in strategic positions, these tools contain a sensor able to detect the relevant condition (a thermometer for temperature, voltmeter for voltage, etc). They also contain a microprocessor that translates the sensor’s reading into legible format, and a data drive to record the measurement.
Modern data loggers are full-on IoT devices, which automatically upload the data to the Cloud. SaaS can be programmed to generate reports of environmental conditions that heavily regulated industries–like pharma manufacturing, medical device manufacturing, and food production–need to be in compliance with regulatory authorities.
One of the first steps to an environmental monitoring plan is to perform thermal mapping of the production facility. Thermal mapping, also known as temperature mapping, is based on the principle that not all areas of the facility are the same temperature at the same time of day or the same time of year.
Manufacturers that execute thermal mapping install temperature data loggers at strategic points of the facility and take readings throughout the year. The time factor of thermal mapping is especially important in climates where summer and winter are drastically different in temperature.
Companies like Dickson are often brought in to perform the mapping process, and develop a complete picture of the conditions within a space, such as a warehouse where temperature-sensitive products might be kept.
The thermal map also helps companies develop a plan to upgrade their HVAC or orient their production facility to maintain optimal temperatures in key areas.
The implementation of adequate QSA may be expensive and/or time consuming, involving the hiring of third-party auditors and inspectors to perform tests and operations that the company’s senior management does not have the time or the expertise to perform themselves.
However, the expense of money and time is usually well worth it. Quality assurance is a key component to a company’s longevity and reputation in the manufacturing sphere.