Imagine being the captain of a ship, and setting a course for a destination. That’s not too hard to imagine. Now imagine that your job as captain is actually to command an entire navy of smaller ships and boats, none of whom you can actually see, and whose ships are all commanded by individual captains, whose priorities and urgencies may be different from yours. No, this isn’t a direct analogy to modern manufacturing. Yet, in looking at today’s reality, the image does convey some of the flavor of the challenges that manufacturers across many industries are facing today.
Sea changes are not always easy to notice. They are similar to other wide-ranging processes in that the build-up may be slow, but the actual shift is unmistakable. When we study history, those sea-changes are called eras or epochs.
Are We In a New Era?
There is abundant evidence that Quality Assurance (QA) has entered a new era. Legislation such as the Food Safety Modernization Act in the food industry signals more market oversight of products/services sold via government regulations across industries.
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.
What makes a new era, what constitutes a sea change? One answer is that precedents are broken, new precedents established, on a fundamental level. In other words, things that are unprecedented become our new reality.
The FSMA is much more than a package of new regulations. As the first major change in how our food supply is regulated in 70 years it is specifically addressing the new reality of how the food supply is grown or produced, and the much more complex system that brings it to the nation’s table. Among other things, the many “firsts” address areas such as:
- Prevention (“For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply.”)
- Inspection and compliance: “…FSMA provides FDA with important new tools for inspection and compliance.”
- Records access: FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.
- Testing by accredited laboratories.
- Mandatory Recall: New authorities include Mandatory Recall when a company fails to voluntarily recall unsafe food after being asked to by FDA.
- Expanded administrative detention of product.
- Suspension of registration.
- Enhanced product tracing abilities (a system that will enhance its ability to track and trace both domestic and imported foods.)
- Additional record keeping for High-Risk Foods.
- Unprecedented authority for the FDA to better ensure that imported products meet U.S. standards and are safe for U.S. consumers (including importer accountability.)
- Third Party Certification of foreign food facilities comply with U.S. food safety standards.
- Certification for high-risk foods as a condition of entry into the U.S.
In addition to the precedent-setting powers and rules above, the FDA’s power is leveraged by a directive to collaborate with other governments and agencies, as well as including inspections performed by other Federal, State, and local agencies to meet the greatly increased mandates for oversight.
It would be a mistake to assume that the food industry is the only one that is undergoing a sea change. One doesn’t have to look far to discover evidence of precedents being broken. As reported in SCM * California, and now, the UK, are taking steps to hold companies to account for human rights violations (specifically slavery) that occur anywhere in the supply chain used to produce the projects they offer on the market.
Europe took a page from California and adopted its approach to corporate responsibility for supply chain transparency, and eradicating slavery and human trafficking in the global supply chain. All companies selling goods and services into both the United Kingdom and California will need to harmonize their global compliance for both jurisdictions.
In March 2015, the United Kingdom passed the Modern Slavery Act (UK Act). This is the first of its kind in Europe. While most of the UK Act addresses the violations and sanctions against those directly engaged in the criminal activities of slavery and human trafficking, the UK Act includes a new corporate reporting obligation that is modeled on a 2010 California law.
What is the sea change?
The essence of the sea change in global supply quality management is about the perception of accountability. While a company might see itself only loosely coupled to the members of its supply chain, the law and society now perceives companies to be welded to them, no matter how far away geographically, or how small the component relative to the product.
The new era of quality assurance is spreading ripples in widening circles. These ripples will eventually reach every manufacturer, no matter where they are located, or how modest their contribution is.
The captains of industry are asking themselves:
How do we maintain control of the quality of our products when we do little or none of the actual manufacturing?
How do we maintain this control even as the legal requirements are playing leapfrog with customer’s demands, driving quality standards onto ever higher plateaus and with ever more specific measures?
The COUNT in ACCOUNTABILITY
With this daunting array of demands from governments, consumers, as well the willingness of companies to shoulder the burden of corporate citizenship, the question of methodology (both as technology and management) naturally arises.
Translating the new perceptions of accountability into real-time management, it is clear that the lion’s share of the work of complying with the new demands consists of the ability to not only comply but to prove and document compliance at an unprecedented level.
Are the systems being used in your company up to these new demands when the regulations are the minimum QA performance?
While it is possible to eventually gather all the documentation necessary to prove compliance, new standards demand speed and close to real-time responsiveness.