In-process instructions for internal specs
When the specification is being created for internal or in-process control, it is most effective when it contains step-by-step instructions for manufacture or conversion and quality or conformance. Each step must reference a material or component, a process and a standard description linked to process capability and expected characteristics. Link target qualities to process equipment and material adjustments using language and techniques familiar to operators.
Finally, there must be measurable criteria for success for completion of the step. Obviously, test criteria, methods and outcomes must be included. Specifics are critical. Single sentence instructions with no guidance or references (to observable standards) must be avoided. Illustrations, photos and examples of target, minimally acceptable and minimally unacceptable quality are also helpful. Process instructions, test criteria and methods can be located in a standalone document, but since the specification estate will most likely be electronic, link the manufacturing process to it for convenience.
Finished product and in-process machinability
Describe the type of equipment, generic or specific, on or with which the item or part will and should be handled. Quantify target and maximum recommended line speed, force, compression (top-to-bottom, side-to-side), dwell, environmental conditions and similar information intended to assist materials handlers and customers as well as characterize limits of the material.
Shipping, handling and storage
Add sections which describe how the packaging is to be contained, protected, secured and shipped. Clearly state where codes for “date of manufacture” and batch or lot number descriptions can be found. Explain to the customer what those codes mean and/or how to decode them. It is acceptable to describe the batch/lot number as “alphanumeric, not decodable by customer” if that is the case.
Explain who can decode it in the event of a conformance issue. Describe the conditions under which the packaging needs to be handled, shipped and stored (temperature, humidity, environment, weight, equipment, etc.), the shelf life from date of manufacture and the maximum age of the packaging when received by the customer.
User guidance and limitations
Many suppliers add language to a spec which cautions general risks of use. The statement essentially advises that since each use and user is unique and outside the control or full understanding of the manufacturer, no warrantee, specific outcome or performance characteristics can be assured or predicted. Add any standard descriptive language not previously contained regarding use limits (consumer reuse, microwaving, temperature limits, dishwasher suitability etc.) affecting safety and performance.
Drawings, illustrations and design
Create a section for design and mechanical/CAD drawings. Create a mechanical drawing with all of the data and illustrations that you and the customer need to measure, evaluate, analyze and assess each aspect and feature of the item. Include radii, measurements, tolerances, features, close-up detail of intricate areas, sectional blowups of tops, bottoms or side features and functions, etc. Add revision dates and descriptions. Provide illustrations, detail and explanations describing crucial aspects of the item, e.g. coloration, graphic size, detail and accuracy, dimensional locations of features such as peelable lidding or attachments.
Special features and accessory documents
Additional sections or documents should be added to describe specific features of specialty packaging or specialty preparation. For example, packaging which is expected by the user to be sterile, sanitized, or similarly prepared and evaluated or tested to validate those conditions for safety and suitability should include quantitative and qualitative criteria for use such as a microbiological properties section with explanations of methodology and any helpful guidance.
Add additional sections to include 21CFR regulatory data and information. For materials with sensitive, restricted, at-risk, controlled or regulated components, add in sections referencing CA Proposition 65 callouts and limits, industry guidelines, compendial limits (USP/FCC, for example) and global/international (WHO/JECFA) substance guidelines and limitations.
Sustainability and recycle
Add disclosure and guidance relating to rework, sustainability, recycle, green etc.
Testing and Methods
Typically, specs include a column on each page to include target, minimum and maximum values or standard descriptions representing expected outcomes. Included in that column are references or descriptions of test methods. Usually, the methods have a number and are linked to a certified standards authority. They can also be described as a “manufacturer method” (Company X # 123, for example). In that case, customers must be provided with the full method including revisions, a challenging task.
References and relevant miscellaneous information
Like a report or bibliography, specs may include references and miscellaneous information and guidance. Remember the objective of any specification estate. It is intended to disclose, explain, document, describe, guide, quantify, qualify and assist internal and external resources from cradle to grave. In the event that anything goes wrong or is in need of investigation, many technical eyes will be reviewing the contents of the spec for anything and everything. In the event of performance issues, quality or suitability, technical experts are likely going to look for verification that the item was qualified for commercial food use which usually involves multiple levels of experimentation, scale-up and commercial manufacturing, all accompanied by documentation.
Each step of the process should be referenced by research notebook numbers, experimental item numbers, provisional approved for use/sale numbers and finally a commercial product code. If any of these references are missing from the spec and related documents, it functions as evidence of process errors or omissions. It is easier to add these references to the specification or its attachments at each step and to make sure that the final commercial item spec ports or pulls in all of the references to versions from development through commercialization, as well as post-commercialization updates and versions.
In my experience, specifications which are vague, limited in scope and detail, incomplete, deceptive, erroneous and interpretive or inconsistent with corresponding MSDS’ and technical data sheets not only tarnish the reputation of those who disseminate them, but expose manufacturers and suppliers to costly claims. Stated differently, a poorly written specification is the technical expert’s best friend and will be used during litigation to illustrate organization unprofessionalism, carelessness and incompetence. Creation of properly written specifications based on full disclosure, usage, regulatory and performance parameters is well worth the time and effort it takes to do it.
Next month: Recommendations for creating a comprehensive packaging process operations and troubleshooting guide
Gary Kestenbaum has 40 years’ experience in the food and packaging industries, 6 as a supplier with National Starch, 18 as a product developer with General/Kraft Foods and 15 as a packaging engineer and developer with Kraft. As senior food packaging safety consultant with EHA Consulting Group, Kestenbaum provides guidance on packaging safety and suitability-related projects for raw material manufacturers, converters and associated supporting professionals. He can be reached at [email protected] or 410-484-9133. The website is www.ehagroup.com.