In Manufacturing, and beyond, Quality and Compliance Management can become significant competitive advantages for Manufacturers. In many cases, meeting Quality and Compliance criteria is sufficient to exceed customer expectations across all areas. It is only through a Quality management system that timely and accurate data can be obtained to maintain Compliance.
This involves implementing a Quality System that is entirely Customer-Centric, leveraging industry regulations and requirements to determine a Manufacturer's reliability. The more regulated the system, the easier it becomes to excel in the eyes of customers simply by adhering to Compliance rules.
But what does Quality mean? A good definition identifies Quality as consistently meeting and exceeding customer expectations. Regulations and Compliance merely define the minimum boundaries of these expectations. If Quality means surpassing expectations, it implies that merely meeting minimum regulatory criteria won't suffice; there's an opportunity for true excellence by going beyond mere compliance.
What makes a Manufacturer excellent can be summarized as follows:
1) Product strategies
2) Processes and systems to translate customer demand into product offerings
3) Support technologies to integrate various company departments engaged in this effort.
Quality Management is crucial in aligning these three areas toward a common goal. When Compliance and Quality are customer-centric, each of these defined areas feels the urgency to collaborate and share necessary information to serve the customer in the most profitable manner possible.
Cost reduction is equally important in supporting Quality Management, for the following reasons:
1) The cost of non-quality for Manufacturers can reach up to 25% of a company's total budget.
2) Many Fortune1000 companies report spending over a billion dollars annually due to non-Compliance costs.
3) Regulatory inspection costs far exceed the costs associated with Compliance and Quality Management activities.
Strategies commonly used to turn Compliance and Quality Management into a true competitive advantage are universally recognized as:
1) Having a single System of Records guiding the Manufacturer toward its Quality objectives.
2) Implementing ERP and Quality Management systems aligned with the actual business and Quality Management system adopted by the Manufacturer.
3) Considering key internal and external parameters such as external supplier quality levels, internal resource needs, and the opportunity to create CAPA workflows (Corrective Actions & Preventive Actions) to optimize Quality levels and address dynamics like process variations, customer complaints, and product inconsistencies.
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