Design Control for Packaging

Meet end-user needs with your packaging through planned design reviews.


John Gagliardi, Founder and president of Midwest Process Innovation LLC (Maineville, OH)

Design review is a key element of your quality system, and it must be approached in a documented and comprehensive manner. Such reviews help ensure that your product design, including that of your packaging, is systematically evaluated to adequately meet end-user requirements.

Design reviews should reflect the dynamics of defined phases of your design process in lieu of periodic hallway meetings or undocumented gatherings. They commonly produce design revisions, process changes, and other productive steps in product and package development. And design reviews can be very profitable if you are measuring how long it takes to put a product out on the market.

FDA provides minimum direction for design reviews in 21 CFR 820.30(e) and further interpretation in the preamble to the 1996 Quality System Regulation (QSR). To meet the spirit of the comprehensive requirements of the cGMP and QSR, your review agendas should at least include the core product being designed, its accessories, components, related software, iterations of graphical presentation, packaging, production and resource requirements, and installation and service, if applicable. This article will focus on the various aspects of graphics and packaging and the impact of design review. It will address some of the detail that is necessary to ensure that robust output requirements are not only met, but also exceeded.

Packaging and labeling issues have long been considered one of the primary causes for market withdrawal and product recalls. Packaging and graphic design involve ensuring the credibility of ultimate performance criteria, physical safety, compatibility, and barrier demands. As a design project progresses, reviews should also cover manufacturability and documentation issues such as assembly drawings, manufacturing instructions, testing strategy, and sterilization validation. The frequency and detail of design reviews is directly related to the complexity of the product and its packaging and graphics requirements. Paying attention to these details during design could reduce the likelihood of having to withdraw product from the marketplace. Your customers will benefit from a robust design-and-development system, smart reviews, and effective corrective and preventive action.


Your packaging and graphics strategy should first be documented in a design control plan. Phase design reviews should be planned. Overly detailed plans invariably fail because they don’t allow for creativity and variability. The plan must include all major packaging and graphics activities and assignments to enable the design to move forward completely and efficiently. Broad plans may be easier to implement, and they require less updating.

Design reviews will challenge the design plan every step of the way, and they should. Having all knowledgeable players participate in design reviews is a must. Not only should packaging and graphics designers be actively involved, but also functional representatives from regulatory affairs, manufacturing, marketing, engineering, quality, documentation, purchasing, and product design. Each function has a role and responsibility, and those functions should be procedurally documented and recorded for each review. This objective evidence is crucial to establishing that your company even conducted a design review in the first place.

Incorporating at least one independent person not involved with the project is not only a requirement—it also makes sense. Issues and problems can be viewed with an unbiased clarity toward resolution. That, in and of itself, is the primary driver for focused and documented reviews. Projects without such input generally fail or end up being way over budget.


The project leader and team should create a master list of packaging and graphics deliverables in the design plan. These are considered before and after each review to act as an agenda or guide and to ensure that the project stays on plan. The objective of all design reviews is to turn end-user and technical requirements (inputs) into specific design requirements and deliverables (outputs).

In terms of packaging and graphics, marketing representatives often bring customer input and requirements to the review. Their questions may include: What is the product being used for? Are the graphics in line with your customer base? Is the packaging material state-of-the-industry? These questions help ensure that user intent is not forgotten or mislaid during the flurry of activities that surround design and development.

Manufacturing initiatives and issues should be brought up with process and equipment in mind. For example, will bar sealers be used, or is the product best served with shrink-wrapping technology? Is it a sterile product and, if so, will it require special loading requirements or carton configurations? Is the package going to be exposed to gamma or ethylene oxide sterilization? Is this product meant for bulk packaging or individual delivery? Can reusable pallets be used? Shipping requirements, logistics, and cost containment should also be considered so that packaging identifies and protects the product. Because of this required synergy, manufacturing is a key partner with the packaging and graphics design engineers.

Regulatory affairs and quality assurance (QA) departments must bless all of these activities and deliverables every step of the way. They will continue to focus on the legalities involved with new-product introduction and ensure that user intent is validated and verified prior to release.

Product and packaging engineers should also bring many deliverables to reviews. The size, weight, shape, and other properties of the product have a direct influence on packaging requirements. Are there special product requirements for light, temperature, humidity, storage, and sterilization? During the verification stages of the final product, will the specifications address the fragility of the product and packaging? What are the parameters for vibration, drop, and shock? Is the environment being considered? Because packaging components and accessories are part of the design’s intent, bringing your suppliers to reviews is not only recommended, but a necessity when critical packaging questions surface or a key decision is being made.


After you select a package and graphics design platform, a first review should be organized to tie concept and feasibility to the preliminary drawings and the initial QA paperwork. This will help focus on the up-and-coming demands of product development phases. The inputs at this review can include product criteria, the early stages of risk analysis, preliminary artwork concepts, design specifications, environmental-impact data, and sterilization demands. Prototype packages can then be constructed and shipping-tested to ensure initial structural stability.

The second review should include these prototypes and test results toward preproduction qualification runs and process and product capabilities. All testing results, preliminary drawings, and capabilities should be challenged during this review. Design changes must be noted and documented as part of the minutes from this session. Risk-analysis updates and packaging failure mode effects analysis (FMEA), both for the design and the process, will be instrumental at this stage in determining the next steps toward final design specifications and reliability testing. Process and production qualifications should be compared to the packaging strategy at this juncture to check progress and product intent.

A third review can further challenge package design to the extent that any anomalies in the plan will surface, even at this late stage of design and development. (Better now than in the field.)

This third review should be focused on verification assurances toward ultimately validating the product to meet user intent. By now, all of the environmental analysis should be completed, reliability testing results summarized in a final report, manufacturing plan approved, process and design FMEAs brought up-to-date, prototype changes finalized, and, generally, testing results quality assured to support manufacturing specifications and drawings.

This third review will take your packaging and graphics efforts up to the engineering pilot phase and eventually initial manufacturing. Validation efforts will be realized and confirmed after this initial production batch. During this review, investigations are coming to a close and manufacturability is close at hand.

Some companies hold yet another review to finalize specifications and tie up any loose ends prior to manufacturing. This is entirely based upon the type of product, packaging configurations, and market demands.


Packaging project leaders must keep up with the various iterations that a new design will inherit. Alignment with other players is imperative. As development, design, and production processes evolve, design reviews will reduce errors, assist in problem avoidance, ferret out existing and hidden problems, enact corrective action toward real solutions, enable reproducibility, ensure compliance using documented objective evidence, and reduce the common problems involved with transferring designs to the product arena. Especially toward the end of the development cycle, these design reviews will actively address the final design in a logical and formal manner. This formality will help ensure that packaging and graphics design requirements and specifications are met. Your customers will react accordingly.

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