All you need to know about creating documents intended to protect consumer safety and the mutual interests of end users and suppliers. Before you respond “So?” know that the least exciting part of your job may represent the most important quality and safety protection for your company.
Readers: I know what you’re thinking! “Oh no, not another sermon from Gary imploring me to create (better) technical documents?”
Well, okay, you’re right; it IS another one of those “best practices” articles, BUT……I have an excuse. It has occurred to me based on actual experiences that many, if not all, of the clients I’ve represented in adversarial matters (legal-speak for “claims and lawsuits”) would have benefitted financially to the tune of six or seven figures if they had created, issued and followed better, more comprehensive technical documents.
Specifically, I’m referring to:
- Component and product specifications (raw material, in-process and finished products);
- Work instructions;
- Test methods;
- Criteria for success (verbal descriptions with illustrations);
- Adjustment manuals complete with references, illustrations and test protocols;
- Operating guides with illustrations and examples;
- Troubleshooting guides;
- Product Data Sheets;
- Raw material pre-use and finished product pre-ship quality inspection manual.
If you haven’t been in a position where products, documents or other items “under your control and on your watch” have come under legal fire and scrutiny, you’re lucky, believe me. All it takes is one experience wherein a high-level big-shot in your organization or, worse, a regulatory representative, has you “on the carpet,” grilling you as to why you didn’t do this, why you allowed that to occur or why you or your staff appeared to be “asleep at the switch,” failing to identify and correct the obvious. Worse, once YOU start reviewing the paper trail, documents and related processes, you will ALWAYS, and, I repeat, ALWAYS, observe errors and omissions that leave you speechless.
Some of those mistakes may or may not be your direct fault or a result of an oversight on your watch, but, regardless, the undeniable fact is that you will identify them as being foreseeable, preventable or correctable…after the fact, or course, once the insomnia-creating event has already happened. Worse, following the inevitable, dreaded “lessons learned” session, when the facilitators and stakeholders rake you over the coals again, it will be exposed that corrective or preventative action steps had been ideated, documented (somewhere) and considered, but never streamlined or implemented.
The connection to food safety is this: Process is connected to quality, which is directly connected to safety in the food industry. Regardless of whether you provide the raw packaging material, convert and process that raw material with other substances, manufacture the equipment to support conversion processes or add the food to the package, you are in a position to control quality and food safety.
If the package material or finished package properties are not designed, converted or used with limits and controls in place, the quality is bound to be affected. Since packaging is created to protect the product, control the conditions surrounding same (moisture, spoilage, oxygen, shelf-life, integrity, configuration, portioning) and function as an enticement to purchase, we assume that there are absolutes, ranges, controls and other parameters intended to limit and control suitability. It is imperative that well-advised limits and safety checks are comprehensive, well -written, understandable and accompanied with practical guidance and illustrations.
How many times have you purchased an item and found what you considered to be simple aspects of instruction and “quick startup” to be non-understandable, missing or buried in an improperly described section? Using your own experiences will give you guidance on just how broad, detailed and comprehensive your documents need to be.
Let’s begin with the most basic of control documents: the packaging material or component specification.
You buy, use, convert and/or sell a food packaging component, material or product. Regardless of whether it is unique, customized or a commodity, it needs to have a comprehensive, fully descriptive item or material specification. That spec must describe what it is by trade and generic name. The first section of the spec should explain the intended and expected (typical) uses. While a food packaging grade component might also be used in the manufacture of industrial goods, its intended use for the sake of this example is in food packaging. Give the user a general description of the fact that it’s used to convert rigid, semi-rigid or flexible food packaging.
Since it is suitable for use in food packaging applications, provide the user with all regulatory reference numbers and documents.
It is in the best interests of supplier and end user to disclose and describe intended uses and applications, limits and exclusions. Add a “recommended uses and suitability” or similar section describing typical uses as well as food applications where an alternate grade or type product would be more suitable. Do not hesitate to include exclusions, warnings, limits and related guidance based on industry experiences, practical expectations and physical/chemical composition.
Composition, layers and materials
Next, add a section to list and describe components, layers or appliqués, coatings or processing aids, completely describing the exact composition of each. Avoid describing subcomponents as a “confidential trade secret” and use of nonspecific and unhelpful nomenclature. If, for example, one of the layers was purchased from a third-party supplier as an intermediate component intended for lamination into the finished film or part, define it (e.g. “multilayer blended PE coextrusion” or similar) at least in general terms, if confidentiality is truly critical.
Be detailed, concise and use language, units of measure and related info that the average packaging engineer can understand or easily covert. I suggest U.S. and metric. Make sure that you use accurate and verifiable language and data taken directly from your supplier’s material data sheets.
If the vendor disclosure and other documents in your possession do not include valid information needed to adequately and accurately populate the materials section of your specification, contact your supplier and request complete or revised technical specifications and data disclosure in advance of completing your specification.
The next section describes the dimensions of your product. Include all dimensions of the item including inside, outside, roll, core etc. Add weights to this section including weights of individual parts, cases, impressions etc.
Create and populate physical/chemical properties. Include properties that will be critical to customer performance and abuse. WVTR, OTR, porosity, permeability, strength, burst, puncture resistance, etc. IF the structure or part includes “active” or intelligent functionality, quantify limits and qualify expectations.
Tolerances, variations and defects
Add a section to describe the quality and quantity of allowable defects, expected variabilities and tolerances, with maximum values or a standard description called out in a separate column for each characteristic in the section.
A very helpful and often overlooked section in packaging specifications refers to “sensory characteristics.” Describe the expected odor or taste of the components as well as the color and visual texture. Characterizing them as “matches standard (reference)” is acceptable if there is also a corresponding description that would be helpful to a packaging tech or material control resource. Examples of honest and accurate sensory descriptions might include “odorless/tasteless” or “slight odor characteristic of (define)” with added language to connect it to a standard that the reader can obtain and compare using a repeatable test method. Sensory descriptions can include typical absence of odor or flavor, accompanied by descriptive specificity. Use of the boilerplate “no off odors” or similar unspecific language will do more harm than good in the event of customer allegation of sensory non-conformance, underperformance or taint. Be sure to reference test methods by ASTM, AOAC, TAPPI or other name and number. If the test method is unique or proprietary, provide an asterisked explanation in the event the customer desires to obtain the method and equipment to perform it.
Next: More crucial considerations