Straight Talk: Program Safety and Compliance for Packaging Professionals

If you've searched EHA's and other websites for keywords "packaging" and "safety" or "compliance", there is no doubt that you've been exposed to an avalanche of warnings, awareness, preparedness suggestions amid a maze of acronyms, laws, agencies, schemes, programs and related jargon all intended to promote the same theme:

"If you are a manufacturer or converter of packaging materials, you'll need to assess whether you have a safety and preparedness program and, if so, have that program evaluated against the GFSI standards for packaging manufacturers".

Over the past year, we've paid close attention to the comments of existing and potential packaging industry clients, many of whom are encountering the same dilemma: How do I react in a prudent and practical manner to the pleas of my customers to align my supply chain and manufacturing procedures with the guidance presented by the GFSI-accredited safety and compliance organizations?

The rhetoric we hear is thematic as well. The most familiar pleadings include:

Issue #1: Why now and why us?

Q: "I've been producing high-quality products out of this facility for as long as I can remember! Like any other manufacturer, we see and deal with quality issues, but we've never had a single customer complaint dealing with a consumer safety or contamination issue. Why are we suddenly being forced to the meet the same expectations as high-risk ingredient manufacturers?"

A:The desire and urgency to hold all packaging and related businesses (accessory to the manufacture of food and edible products) to high safety standards is borne out of practical responsibility following actual incidents, fear, politics and public pressure, all factored by the electronic age where information and detail is only a touch screen away.

Every day, risk and exposures are uncovered in the food and materials supply chain. Even though you believe that the output of goods you sell which support the food industry has never contributed to a health or safety hazard situation (documented by the absence of any complaints), past freedom of fault is not in and of itself a substitute for a proactive risk mitigation program based on guidance from governmental regulatory agencies and industry organizations dedicated to the public good.

They've mandated that companies KNOW the materials they are using and the products that they are shipping are free of safety hazards, as opposed to depending upon on "certificates of compliance and analysis" from a second or third party. FSMA says, in effect, if you touch it, you are responsible for controlling every aspect of quality and safety from intake to shipment.

As to the question of "why now", if you're manufacturing food contact packaging and materials, FSMA has not radically changed how regulators evaluate your products. You are still held to the same expectations and legal requirements as anyone who produces ingredients and additives. FSMA does not add to the level of legal responsibility, rather it specifies and documents programs, steps and procedures that must be followed to support and document that you're doing the right thing to make and sell a safe product and can show and prove it on demand, if asked.

As far as 3rd party inspections and certifications are concerned, they are a way of standardizing and formalizing worldwide methods of evaluating and grading facilities and the people and programs within. As with any other technical discipline, standardization of expectations and procedures is not considered weird or intrusive; rather, it is welcomed by all levels of industry, commerce, healthcare and science.

Issue #2: "Am I at personal risk if my name is on certificates of guarantee or quality if we do not have a certified program in place?"

Q: "I may be caught in a bad situation. On the one hand, my name is on every boilerplated quality compliance document that leaves our manufacturing facility. Those documents imply that our company meets or exceeds the highest industry and governmental standards for food safety, but from what I'm hearing and seeing in the industry, that may not be true. Am I at personal risk if we encounter a food safety issue in the future"?

A: Every situation is different, so it is difficult to opine on legal risk, however where laws and regulations are in place, it is expected that quality and regulatory manages and certifiers know what is expected within their industry regarding health and safety and that any representations of same in the absence of industry-standard and recognized programs represent risk to the corporation in the event that a public health or safety incident should occur. Proof of risk analysis and mitigatory programs assist in demonstrating intent. Inspections, certifications and the implementation of a "best practices" process take that intent to the highest level.

Issue # 3: "How and why is the GFSI standard used as a Model?

Q: "I'm satisfied that my company's converting facilities are run under the auspices of a GFSI-accredited program, but I know that my key strategic suppliers are not. A representative from our quality organization recently toured a suppliers facility and reported back to me that they did not measure up to the standards required by GFSI and were very sensitive to the concept of being evaluated against a GFSI scheme."

A: GFSI is a non-profit branch of the Consumer Goods Forum, a global (consumer goods) industry-based organization dedicated to serve and improve related industries. One of the five strategic priorities is health and safety, with the responsibility for same delegated to GFSI. GFSI, like its overseeing organization, is a global entity composed of representatives from vendors, manufacturers and related companies whose objective it is to partner in identifying food (and related support materials, processes and equipment) safety risks and creating programs and steps to mitigate and control them. Having said this, the GFSI-based schemes are a model and template for risk analysis and improvement.

Success and commitment is not always measured in how many individual expectation categories one meets, but a desire to prioritize, understand risk and improve. One of the primary objectives in the GFSI initiative on safety and compliance is harmonization of expectations, evaluations, grading, and related activities, as well as inspector qualifications, accreditation and certification.

GFSI's slogan, "Once certified, accepted everywhere" connotes unification and recognition of both expectations and results.

Issue # 4: "As a Supplier or Vendor, what aspects of (non) Compliance are my customers concerned with"?

Q:"I have a long and satisfying relationship with my strategic vendors. It's been challenging, but over the years our purchasing department has negotiated lowest-cost continuous supply contracts with them. They are very flexible, give us unparalleled technical and customer service and, frankly, we couldn't replace them even if we wanted to. We've broached the subject of (GFSI) compliance and they've told us that is a commitment that they are not prepared to make at this time. Management has made it clear that this relationship is critical and that no one is to do anything to endanger it. What can I do to protect the quality and integrity of our products while at the same time honoring management's edict"?

A: We've heard real concern from clients that they either don't know what level of health and safety compliance their vendors are achieving or, of greater concern, that vendors are pushing back against proof of compliance and are threatening their customers with withdrawal from supply rather than confirm to industry-standard program guidelines.

Stated plainly, your customers and suppliers who have committed to compliance through consultant evaluations, upgrades, inspections and ultimately, certifications, are looking for proof that your organization is committed to the same level of safety and compliance as they are. They are concerned, and rightfully so, that one food safety glitch by an industry partner taints everyone in the chain.

In many cases, supplier contracts have been painstakingly negotiated and movement to an alternate vendor is not an option. In cases such as these, a softer approach and compromise is not only a viable option, it is the ONLY option. Supply chain partners must be cultivated and treated as such when being introduced to the latest health and safety expectations.

Customers and end users need to recognize the tenuous position that these vendors are in and are best off considering specific circumstances and practicality rather than mandating unenforceable timelines and impractical cost models. That is no knock against the GFSI-based programs which address all risks recognized to date; however practitioners are often intimidated by the breadth of these programs and are convinced that compliance is an "all or nothing" approach as opposed to a commitment to attainable levels of continuous improvement.

"Is the Cost of Compliance Out of Control?"

Q: "My supplier has made it clear that if they are to become compliant with a GFSI-based program, it will take a lengthy amount of time, they will have to do it in increments, resources will have to be assigned and the cost will be borne by our company. When they told me the cost, I was staggered. They were not talking about a one-time expense; they told me that the cost of goods would increase exponentially in addition to one-time pass-along costs for resource and infrastructural upgrades. Are they justified in their approach and are there any options to avoid this unacceptable and disruptive impact to our current workable business model"?

A:Undoubtedly, full compliance from beginning to end can be daunting. In most cases, as we've discussed previously, the professionals who contact us at EHA Group sound overwhelmed, intimidated and frustrated by the specter of cost, degree of difficulty , resources and sheer change.

We talk "inquirers" off of the figurative cliff and advise them that circumstances are not nearly as dire as they think. We tell them that, in most cases, they have a solid framework for compliance already in place, supported by functioning programs that need adjustment and improvement, not elimination and replacement. The most frequent challenge we face with clients is that programs are in place, but not properly documented.

We find that describing, supporting and documenting them on paper in a standard format gives existing programs credibility and provides evidence of practice and compliance.

These and other messages from client and client vendors raise honest and reasonable issues, which are borne from real-world concerns about cost, business culture, practicality and benefits vs. harm and disruption.

At EHA, we've listened intently to these concerns. The following responses represent, we believe, honest and practical considerations for packaging materials and converting organizations.