ISO 9001:2000 for Carton Manufacturers: Why Clause 7.3 on Design and Development Should Stay

Industry practice shows that most carton manufacturers, when seeking ISO 9001:2000 quality management system certification, remove Clause 7.3 entirely because they believe their organization has no design and development element. This article argues that such an approach is not appropriate.

1. Removing the design and development clause weakens a company's ability to deliver products that satisfy customers. Any organization engaged in hardware production still needs corresponding software support. ISO 9001:2000 therefore sets quality management requirements not only for hardware production but also for software design and development.

In carton manufacturing, product design and development is generally documented through two outputs. The first is a graphic file—a drawing or layout—that converts the customer's mental image of a carton into a flat carton on a medium. The second is a work instruction—a production process sheet—that converts the flat carton into a three-dimensional carton with defined functions and performance. During product realization, product design and process design are key processes that determine whether the final product can meet customer requirements. For this reason, the quality management system standard specifies planning, review, verification and control requirements across the entire design and development process. The purpose is to fully, accurately and completely reflect customer requirements or known intended-use requirements, and then use process design to select suitable methods and steps so the final conversion meets customer requirements and expectations.

However, when carton manufacturers exclude design and development for ISO 9001:2000 certification, this process can become uncontrolled during system operation. Product and process design are not monitored in a timely way, measured appropriately or controlled as needed, and the conformity, suitability and effectiveness of the two design outputs are not confirmed. Clearly, this reduces the organization's ability to provide qualified products that satisfy customers. The article notes an example: in the organization concerned, one third of the quality accidents in 2002 were caused by design and development.

1. Removing the design and development clause also places the organization's certification qualification in question.

As stated earlier, carton manufacturers have both product design and development and process design and development. Deleting the design and development clause during quality management system certification removes a quality management requirement suited to the organization and its products. The consequences are twofold. First, the organization's quality management system documents lose an important chapter capable of effectively monitoring product realization; within an interrelated and interacting system, a very weighty element disappears. The system documents become incomplete and lack systematicness and integrity.

This also creates a serious inconsistency between the quality manual—the guiding document of the quality management system—and the ISO 9001:2000 standard. At the same time, during actual system operation, the product realization process that truly exists in the company does not match the process-based quality management system model. The real design and development process cannot operate under documented rules, which inevitably prevents design results from satisfying customer requirements.

Clause 1.2 Application of Quality Management System Requirements states that when a requirement of the standard is not applicable because of the characteristics of the organization and its products, an exclusion may be considered. It also states that conformity cannot be claimed unless the exclusion falls within Chapter 7 requirements that do not affect the organization's ability or responsibility to provide products meeting customer and applicable statutory and regulatory requirements. Therefore, a carton manufacturer that deletes design and development is no longer qualified to declare that its quality management system and its operation conform to ISO 9001:2000. Naturally, it also loses certification eligibility.

1. Carton manufacturers do have a special product design and development process.

Do carton manufacturers really have product design and development? The answer is yes. Their design and development process is often particular and sometimes appears too simple, making it easy to overlook or misunderstand. In fact, because organizations receive customer requirements in different ways and receive different types of information, carton companies show three different design and development processes:

The first is 'stage design.' Carton design and development is divided into two stages: an initial design stage and a redesign stage. The customer completes the initial design, while the carton maker completes the redesign. The carton company's product design and development process starts with input from the customer's basic design and ends with output of the design result. The reason for dividing the work is that most cartons designed by customers themselves are rough and sketchy and cannot be used as technical documents. After receiving the customer's 'work' by faxed drawing or sketch, the carton factory must carefully revise, refine and supplement it. As the later-stage improvement within the overall design process, this is an extremely important phase in carton product design and development.

The second is 'reproduction design.' Here, the customer's physical carton sample or box-face pattern is used as the basis and transferred onto another medium. This is still called design because the manufacturer does not simply 'copy' the customer's design information. Instead, according to production needs, designers must complete one conversion after another while keeping the result exactly consistent with the physical sample provided by the customer.

Beyond those two product design and development processes, carton factories also have 'full-process design.' This type of design uses the packaged item or inner packaging box sent by the customer as a reference, or relies on simple requirements raised by telephone or in a face-to-face discussion. In this method, the customer fully entrusts the manufacturer with designing and developing the packaging container.

——This article is reprinted from China Packaging Network (pack.cn), original link: http://news.pack.cn/show-362271.html