Quality Management in Industrial Instrumentation
In industrial manufacturing and engineering circles, we hear the word 'quality' more often than we can count. There seems to be a universal interest in achieving high quality, but what exactly does 'quality' mean, and is it measuring the same metrics in every application? More specifically, what does the mention of 'quality management' mean for those of us in the industrial instrumentation world?
For instrumentation manufacturers such as Whitman Controls, providing high quality means that our instruments perform their functions as promised, allowing end users to achieve the safety, performance, and accuracy levels that they expect in every product. More than this, maintaining high quality levels over time without waiver signals our trustworthiness and dedication to our clients' long-term success. In this context, the act of Quality Management is therefore a manufacturer's internal set of methodologies and practices that ensure these outcomes - that is, that we continually exceed our customer's expectations, upon initial purchase as well as perpetually into the future. These practices can be bundled together into a packaged process known as a Quality Management System, or QMS.
Developing Quality Management Systems in Accordance with ISO 9001
Not all QMSs are created equal, nor do they measure the same metrics across industries and applications. This is where a QMS Standard comes into play, which is a body of standardized principles that a QMS can embody when being developed. The ISO 9000 family of Quality Management standards is the most highly regarded, internationally recognized standard set in existence. Within this family, one specific document contains the core specifications that a QMS should include, known as the ISO 9001:2015 Standard on Quality Management Systems - Requirements. ISO 9001 is not a quality management system itself - instead, ISO 9001 offers guidance and details that manufacturers can follow when assembling their own QMS. Companies often seek out certification of their QMS against ISO 9001 requirements - just as we've accomplished here at Whitman Controls, achieving this certification cements a company's dedication to formal, professional, companywide quality management.
To finish answering our earlier questions, what benefits are gained by industrial automation manufacturers (and similar companies) when following a QMS built around ISO 9001? Such a QMS provides these four benefits:
- Enables the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
- Facilitates opportunities to enhance customer satisfaction.
- Addresses risk and opportunities associated with its context and objectives.
- Provides the ability to demonstrate conformity to specified quality management system requirements.
ISO 9001 Certification - What it Means to Instrumentation Manufacturers and Purchasers
To better explain the ISO 9001 Quality Management System standard, let's list and describe each of the core elements required to be reflected in compliant QMSs. At the same time, we'll provide examples of each component in the context of industrial instrumentation manufacturing and purchasing to help readers understand what ISO 9001 certification means to their projects. Quality Management Systems certified against ISO 9001 must achieve the following objectives:
- Set Clear Expectations - quality management is adopted with clear intentions, focusing on exceeding the needs of interested parties involved in the products and services being delivered. A good QMS must identify these expectations at the onset, so that practitioners never lose sight of their ultimate objective. With instrumentation manufacturing, expectations center around personnel safety, process integrity, and ethical representation of a sensor's true capabilities, risk factors, and failure conditions.
- Document Requirements - a competent QMS serves to capture all requirements expected of a manufacturer, its products, and its processes, so that all aspects can be cross-checked over time. Further, diligent change management must be employed to make sure that any revisions to the requirements are logged and communicated appropriately. For automation products, this can include everything from technical specifications to testing parameters, and so on.
- Establish a Workflow - once quality requirements are documented, a workflow can be developed that manufacturers will follow throughout their operations. ISO 9001 is a process-driven standard, utilizing the Plan-Do-Check-Act (PDCA) cycle to translate customer requirements into tangible manufacturing actions. Instrumentation quality checks and testing in particular must follow a rigorous process to be reliable.
- Standardize Procedures - workflows can have a level of inherent variability to them, depending on the operators, products, materials, tooling, and other conditions in play at any given time. To combat this variability, ISO 9001 certified QMSs serve to standardize business operations and manufacturing procedures. Standardized instrumentation production and testing processes are infinitely more dependable than non-standardized methods.
- Measure Performance - the Plan-Do-Check-Act cycle gives specific attention to monitoring and measuring processes against the above policies, objectives, requirements, and planned activities, keeping all aspects of production in line with expectations. Quality control testing and in-line production sampling are two examples of how instrument OEMs measure internal performance.
- Manage Risk - ISO 9001 is universally known for its Risk-Based Thinking foundation, upon which the rest of the standard is built. Risk-Based Thinking frames a business' perspective on all aspects of their operations. For example, if a sensor manufacturer wanted to cut production costs by reducing their material specs, Risk-Based Thinking would dissuade them from reducing specs beyond a point where undue risk was introduced.
- Map Decision Paths - tough business-scale decisions are hard enough to make, let alone when they have to be made in a hurry based on limited information. To avoid such situations, ISO 9001-compliant QMSs employ decision maps to help guide critical decision paths that are likely to come up. For sensor OEMs, this mapping effort is very useful for guiding quality control inspections and induced-failure testing processes.
- Facilitate Continuous Improvement - quality management is largely about ensuring safe, dependable products today, but it's also about pushing continuous improvements out over the long haul. Automation component vendors actively poll their operations for opportunities to enhance quality objectives, rolling these enhancements into their daily practices.
- Audit Quality Program Success - no quality management system is complete without an integrated method of auditing itself for both failure points as well as successes. ISO 9001-compliant QMS include robust audit programs, where every last established practice, procedure, and expectation can be measured and evaluated. Instrumentation vendors rely on these audits to make sure that their QMS is at full health, and that as new technologies and products roll out as they so often do in this arena, the QMS stays ahead of the curve at all times.
As a veteran-owned small business, Whitman Controls is dedicated to supplying premium quality, reliable, technologically advanced instrumentation for use in nearly any application. Our Bristol, CT manufacturing facility embodies over 40 years of engineering, fabrication, and customer service expertise, serving both end-user and manufacturing customers nationwide through direct and distribution channels. Our values drive us to provide the highest level of servant partnership that you can find. To discuss your applications or to learn more about our capabilities, please contact us at (800) 233-4401, via email at [email protected], or online at www.whitmancontrols.com.
