In the past few years, the workload of staying in compliance with government regulations has increased several fold. It is not the “fault” of any one government or country, but a general, worldwide trend. It’s has been driven by the increased reach of complex, multi-tier supplier networks and inadequate QA management tools, as well as an impatient consumer wanting to know more than ever before.
When breakdowns in quality reach our headlines, often the biggest brand is in one country, and the source of the problem in another, possibly several tiers back in the supply chain.
In response to the public attention caused, as well as to the scope of the scandals (some of which have led to deaths and serious illnesses, as well as the incarceration of top management), new regulations are passed that exceed in scope anything we’ve ever seen before. Some of the wide-ranging changes include initiatives such as:
Companies committed to keeping their ISO certifications must now contend with achieving the new standards in an updated version: ISO 9001-2015.
The Food Safety and Modernization Act (FSMA) encompasses the entire food industry. As the FDA characterizes it, the “FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.”
The International Automotive Task Force (IATF) has issued IATF 16949:2016, an update to the ISO/TS16949:2009, requiring that companies in the automotive industry successfully transition to the new standard by September 14, 2018, if they want to retain their certification.
In fact, entire new industries have sprung up to help companies achieve the necessary competence in making sure they are able to comply and stay in business in their own industry, with access to the largest (and usually most regulated) markets.
The Parable of the Street Light
One night, Nasruddin the Sage was walking home along a dark street. Suddenly he saw a man crawling around under a street light. For a while, Nasruddin watched the man desperately crawl back and forth in the cone of light being cast by the bright lamp above him. Curious, Nasruddin asked “What are you doing, my good man? What do you seek?” The man answered, “I am looking for a key I lost.” Nasruddin, a helpful sort, got down on his hands and knees and joined the man in looking for the key. After a few passes, he stopped. “My good man,” he said, “there’s no key here. Where did you drop it?” The man pointed to the dark, to the shadows near some densely planted bushes across the street. Nasruddin asked, “If you dropped your key over there, why are you looking over here?” The man answered, “Because that’s where the light is, of course!”
Ah, the light! This is where we should focus.
Paradoxically, the plethora of new regulations can imperceptibly skew a company’s natural path towards becoming a best-practice-level practitioner of Quality Assurance, because compliance is becoming so voluminous, time-consuming and comprehensive. Processes and their documentation can take on the status of an end in and of themselves.
What’s Left in the Dark?
The essence of quality assurance is ensuring the quality of the materials flowing through the supply chain, as constituent parts of a final product. Each lot, each shipment, each of these materials, the object of all the documentation, may at some point end up as the key that was lost in the dark.
The answer to preventing the loss of that “key” is the testing of mission-critical lots, validating acceptable results in an electronic form, tracking their shipments, and follow-up skip-lot laboratory testing, along with the tools that allow your company to respond to the results of the tests. This allows a company to truly know the material variability of the materials flowing in their supply chains. Some, of course, will be substandard, and your company can quickly see any anomalies and respond before they proceed through the supply chain, contaminating it with substandard or counterfeit material, bypassing the barriers that all the new documentation and new regulatory requirements are designed to establish.
To assess the degree to which the QA effort is geared to the purpose satisfying regulatory requirements, rather than to producing documentation that safeguards product safety and performance, it’s useful to consider the following questions:
Is supply quality management being performed by using periodic audits or with a defined, ongoing testing regimen?
In other words,
- Is every lot being tested, using reliable measures of the appropriate elements and characteristics?
- Is the data being provided directly by suppliers using a standardized template and in electronic form, or is it in a supplier-generated form of the document requiring eyeballs or transformation from format to format to be actionable?
- Is the data instantly available to be processed through Statistical Process Control (SPC), which can quickly display a trend in either a positive or negative direction, and can detect falsification?
While some companies have realized that the electronic approach and ongoing testing are the right things to do both to protect the reputation of the company and the safety/satisfaction of its consumers, many others do not know that these solutions are available and are cost-effective.
Our product GSQA® is designed and time-tested to manage this situation and assist in achieving regulatory compliance across industries, and over the web. View our modules page to learn more about how each of our broad software features improves supplier quality management.