Embarking on production can become a harrowing ordeal for design teams unfamiliar with production quality or those previously burned by manufacturers without the necessary protocols. When time-to-market deadlines are tight, there can be significant pressure to find a manufacturer who meets cost, lot size, and production capabilities; however, all these factors are for naught if the finished product offers poor quality and performance. Designers should begin their search criteria with an ISO 9001-certified manufacturer that has received an independent assessment of operational competence.
How Do Manufacturers Define Quality?
Organizations require a quality manufacturing system (QMS) to provide repeatability and guide the overall refinement of processes that ensure competitive risk-taking and alignment strategies. While ISO 9001 does not aim to provide uniformity to other quality management systems (indeed, ISO 9001 offers an open-ended solution approach to its implementation over strict requirements), it does offer a Plan-Do-Check-Act (PDCA) method to meet the desired QMS outcomes. This cyclical process operates on four levels of quality management:
- Meeting requirements and the value of consistency.
- How new or altered processes can add value to the product.
- Achieving business objectives with newfound value.
- The improvement of processes based on qualitative and tangible data closes the loop.
In reality, the manufacturer of a complex product like a PCBA only represents a small stage of the supply chain; as such, optimization of operations can only occur by examining the whole supply chain:
| ISO 9001 Certified Manufacturer Supply Chain Factors | |
|---|---|
| Input Sources | Raw materials, sub-products, and other inputs of direct inputs. |
| Inputs | Materials, energy, and labor consumed during the product’s creation. |
| Activity | The entire production process for a single manufacturer. |
| Outputs | The product or service rendered. |
| Output Receival | The manufactured product’s end-use by customers, industry, etc. |
Typically, manufacturers focus on their direct responsibility, i.e., the “Activity” portion of production. Of course, ensuring the best processes during production extends to preceding and succeeding manufacturing production levels – for example, providing the proper temperature and humidity control for board materials, proper packaging in EMI shielding to prevent damage during transit/handling, etc. By taking a more active role in the management of the product beyond manufacturing, businesses can track performance and leverage this data in the direct manufacturing process.
As mentioned, PDCA forms a critical backbone of the ISO 9001 QMS. Each step indicates a gradual improvement in the overall process:
- Plan – Establish objective requirements and determine resources necessary to achieve goals.
- Do – Implement requirements.
- Check – Monitor and measure processes against objective requirements while reporting results.
- Act – Take actions to improve performance, as necessary.
How ISO 9001 Certified Manufacturers Implement PDCA
Risk is an exciting concept for a QMS in a competitive environment: businesses need to limit their exposure to risk while also taking the opportunity to leverage it when available strategically. For example, nonconformities occurring during manufacturing require corrective action so manufacturers can isolate their development in the production process and implement the proper solution. By thoroughly analyzing nonconformities, additional avenues for improvement may present themselves. Manufacturing managers must balance risk and opportunity by providing products and services that meet customer demands, industry standards, and regulations while improving manufactured products’ quality, reliability, and conformity.
Therefore, planning must begin with strongly defined leadership and benchmarks that can guide and act as nominal reference points. Leadership has to enshrine customer focus, which keeps production a self-improving process by continuing to meet and exceed the ever-greater demand (both in quantity and quality) of the entire customer base. Management communicates this throughout the organization with a policy that must provide the framework for meeting quality goals while communicating and updating the policy in response to regulatory requirements and changes in customer demands. With the overall scope defined, ISO 9001 shifts back to the PDCA foundation:
| Plan-Do-Check-Act Details | |||
|---|---|---|---|
| Plan | Do | Check | Act |
| Address risks and opportunities
Quantifiable quality objectives
Resources
Organization training/competence
Communication
Documentation |
Operation controls
Manufacturer requirements
Design and development
Controlling for external processes
Controlling for nonconformance |
Monitoring and measuring
Evaluations
Internal audit
Management review |
Corrective action for nonconformance
Continual improvement |
Your Contract Manufacturer Delivers and Continually Refines Quality
While ISO 9001 is a thorough framework for implementing quality management systems that improve customer satisfaction, regulatory adherence, and product quality, an ISO 9001-certified manufacturer has ample leeway to realize these goals; there is no “one size fits all” approach. An ISO 9001 certification communicates to the customer that the manufacturer has internal and external motivations to act in the customer’s best interest (since these policies align with the manufacturer’s best interest). For any PCB fabrication or assembly needs, VSE is here to help. At VSE, we’re a team of engineers committed to building electronics for our customers, including an organizational dedication to improving our customers’ products and experiences. We’ve worked alongside our valued manufacturing partners for over forty years to realize life-changing and life-saving devices.
