5 Things to Know About Manufacturing Quality Assurance

This might seem counterintuitive, but quality assurance (QA) in manufacturing isn’t entirely about the quality of the product being manufactured.

That’s actually quality control (QC), and it forms a critical part of QA. But QA itself is more about the assurance component—not just making quality products, but assuring other people of their quality.

ISO 9000, a widely-accepted compliance standard, defines quality assurance as “part of quality management focused on providing confidence that quality requirements will be fulfilled.”

Providing confidence to whom? Customers? Retailers? Employees? Regulators? All of the above?

It’s definitely “all of the above” — in some industries to a greater extent than others. Assuring your customers, retail carriers, and applicable regulatory bodies is something that every manufacturer has to pay close attention to. Quality assurance is even important to your employees, as they are crucial partners in the manufacture of quality products and their buy-in is important.

Here are five things to know about manufacturing quality assurance: 

1. Quality Assurance Reduces Costs

A major component of quality assurance in manufacturing is adopting practices that standardize and reduce variability in your manufacturing processes and output. After all, how can people be assured of the quality of your output if the output varies from one production run to another?

Methods of standardization can include adopting recipes, formulas, and standard operating procedures (SOP).

This has the beneficial effect of eliminating manufacturing waste, in the form of excess transport, excess production, excess storage, excess processing, rework for quality purposes, product defects, and delivery delays.

This translates to streamlined processes, which translates to lower costs and more profit. Understood through this lens, it’s easy to understand why more manufacturers believe they can’t afford to neglect QA, compared to those who believe they can’t afford it.

2. Quality Assurance Leads to Satisfied Customers

You might think it would go without saying, but it’s amazing how many manufacturers seem to lose sight of the fact that quality products lead to satisfied customers–and satisfied customers are repeat customers. 

In an effort to cut costs, some manufacturers neglect quality assurance, which leads to a downward spiral of lost customers and decreasing revenue.

By contrast, an investment in quality assurance leads to greater customer loyalty, which leads to an upward spiral of brand strength, repeat business, and referrals. In this context, QA is one of the most important investments manufacturers can make in the longevity of their operations. 

3. Quality Assurance is Essential for Regulatory Compliance

Most manufacturers face some level of regulatory compliance burden to operate legally, even if it’s just compliance with OSHA (Occupational Safety and Health Administration) requirements to maintain employee safety on the manufacturing floor. Compliance with OSHA regulations can form a critical part of your quality assurance strategy.

Other industries have much higher regulatory burdens. The food, pharmaceutical, and medical device industries face regulatory compliance burdens from the FDA (Food and Drug Administration), while the aerospace manufacturing industry must comply with regulations like AS9120, an aerospace-specific variant of ISO 9000. 

For these industries, QA becomes an essential component of a strategy to remain compliant with these regulations and keep the doors open, by the grace of the applicable regulatory bodies.

4. Quality Assurance Facilitates Communication, Record Keeping, and KPI Tracking

You can’t improve anything you can’t measure. To improve and validate the quality of products and processes, businesses depend on key performance indicators (KPI) to help them understand when they are moving in the right direction and what needs improvement.

Committing to quality assurance is an opportunity for a manufacturing organization to get clear on what KPIs demonstrate the quality of the output, without one KPI undermining other departments. This fosters communication between different departments within the organization to create unity of purpose.  

Tracking KPIs for quality assurance creates a record of manufacturing processes and activities, which can be used for regulatory compliance as well as quality assurance. 

Manufacturing and other organizations often deploy an integrated enterprise resource planning (ERP) software solution as part of their QA and KPI tracking procedures. ERP systems can also compile SOPs and contribute to the streamlining and cost-cutting process to make the operation more efficient. 

5. Equipment Validation is Essential to Quality Assurance

Manufacturing QA isn’t just about the quality of the products. Most manufacturers use equipment as essential tools in the manufacture of products. QA for manufacturing therefore must include validation of the quality of that equipment—that is, validation of its proper installation and functioning according to factory parameters.

In regulated industries, IQ OQ PQ is the standard process for evaluating equipment. This Dickson guide is a good primer. Essentially, IQ OQ PQ validates the manufacturing equipment in three stages:

  • Installation Qualification (IQ) — validation that the equipment was installed properly, positioned optimally in the facility, with adequate access to power and all components in the packing list. 
  • Operational Qualification (OQ) — validation that all components of the equipment perform according to the manufacturer’s parameters, before being placed into production mode, with repeatable results. 
  • Production Qualification (PQ) — validation that the equipment performs according to the manufacturer’s parameters under production conditions — to be completed before the equipment is actually put into production, to produce repeatable results.

While manufacturers outside of highly-regulated industries may not have to validate equipment according to IQ OQ PQ standards for compliance purposes, it remains an instructive quality standard that even non-regulated manufacturers should consider observing.

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Quality assurance is a fact of life for manufacturers in heavily-regulated industries like food, pharma, and aerospace. But even manufacturers who don’t face stiff compliance burdens should look at the standards that manufacturers hold themselves to (and are held to) when public health and public safety are at stake. If you want to build your brand up with a reputation for quality, what better standard can you follow?

Once you commit to QA, the next step is to implement quality controls under the auspices of a quality management system (QMS) — a system of quality controls that is repeatable, trainable, and unified by buy-in from all stakeholders.