Carton Manufacturers Should Not Exclude the "Design and Development" Clause in Quality System Certification

It is understood that the vast majority of carton enterprises, when conducting ISO9001:2000 quality management system certification, delete clause 7.3 in its entirety on the grounds that their organization has no "design and development" element. The author believes that this practice is inappropriate.

1. Deleting the design and development clause reduces the organization's ability to provide products that satisfy its customers. As an organization, as long as there is hardware production, there must be corresponding software to support it. Therefore, the ISO9001:2000 quality management system not only sets quality management requirements for hardware production, but also sets quality management requirements for software design and development.

As everyone knows, the design and development process of carton enterprise products consists of forming two documents: one is a graphic file — a drawing or design — that transforms the virtual carton in the customer's mind into a flat carton on a medium; the second is work instructions — a production process sheet — that transform the flat carton into a three-dimensional carton with certain functions and performance. It should be said that in the process of product realization, product design and process design, as one of the processes, is a key process that determines whether the final product can satisfy customer requirements. Therefore, the quality management system standard specifies in detail a series of management requirements for the entire design and development process, such as planning, review, verification and control. Its purpose is to ensure that customer requirements, or known intended-use requirements, are fully, accurately and completely reflected, and, through process design, to select appropriate methods and steps so that the final result of this transformation can satisfy customer requirements and expectations.

However, when carton enterprises conduct ISO9001:2000 quality management system certification, they delete the design and development clause, which means that, during the operation of the quality management system, the design and development process will be in an out-of-control state. They neither monitor the two design processes of product and process in a timely manner, nor measure them appropriately and control them as necessary, nor confirm the conformity, suitability and effectiveness of the results of these two designs. Obviously, this will reduce the organization's ability to provide qualified products that satisfy its customers. There is an example to prove it: one third of the quality accidents that occurred in this organization in 2002 were caused by design and development.

1. Deleting the design and development clause will call the organization's certification qualification into question

As stated above, carton enterprises not only have a product design and development process, but also have a process design and development process. When certifying the quality management system, deleting the design and development clause means deleting a quality management requirement suited to the characteristics of the organization and its products. The consequences are, first, that the organization's quality management system documents lack an important chapter capable of effectively monitoring product realization, and, in their interrelation and interaction, lose a very weighty element, so that the organization's system documents become incomplete and lack systematicness and integrity.

This gives rise to a serious inconsistency between the quality manual, the guiding document of the quality management system, and the ISO9001:2000 quality management system standard. Second, during the actual operation of the quality management system, the product realization process that actually exists in the organization does not match the quality management system model based on the reflection of processes. The design and development process that actually exists cannot operate under the regulation of the documents, which inevitably makes it impossible for the design results to satisfy customer requirements.

Section 1.2 "Application" of "Quality Management System Requirements" clearly points out: "When any requirement of this standard is not applicable due to the characteristics of the organization and its products, it may be considered for exclusion." It also points out: "Unless the exclusion falls within those requirements in Chapter 7 of this standard that do not affect the organization's ability or responsibility to provide products that satisfy customer and applicable statutory and regulatory requirements, conformity to this standard cannot be claimed." On this basis, we can say that carton enterprises that delete the design and development clause are no longer qualified to declare that their organization's quality management system and its operation conform to the ISO9001:2000 quality management system standard. Naturally, the organization also loses its certification qualification.

1. Carton enterprises have a special product design and development process

Do carton enterprises have a product design and development process or not? The answer is affirmative. It is just that their design and development process is mostly particular and sometimes appears too simple, and is therefore easily overlooked and misunderstood. In fact, the design and development of carton enterprises takes three different forms, depending on the different ways in which the organization accepts customer requirements and the differences in the content of the information received:

One kind is "stage design". So-called stage design means dividing the design and development of a carton into two stages: first, the initial design stage; second, the redesign stage. The initial design is completed by the customer side, and the redesign is completed by the carton maker. The product design and development process of a carton enterprise starts from the input of the customer's basic design and ends with the output of the design result. The reason carton design and development is divided into two parts is that the vast majority of cartons designed by customers themselves are rough and sketchy and cannot be used as technical documents. Therefore, after the carton factory receives the customer's designed "work" by faxing a drawing or delivering a sketch, it must carefully revise, polish and supplement it. It should be said that, as a component part of the whole design process, that is, the refinement and improvement at the later stage, this is an extremely important stage in carton product design and development.

The second is "reproduction design". So-called reproduction design means taking the physical carton sample or box-face pattern provided by the customer as the basis and transferring it onto another medium. The reason this kind of "reproduction" is also called design is that, after the manufacturer receives the customer's design information, it does not carry out a simple "copy", but rather, according to production needs, the designers must complete one conversion after another, and in the process of conversion maintain not the slightest difference from the physical sample provided by the customer.

In addition to the above two product design and development processes, carton factories also have a "full-process design". So-called full-process design is design carried out using the packaged item or inner packaging box sent by the customer as a reference, or based on simple requirements raised by telephone or in a face-to-face discussion. In this way, the customer fully entrusts the manufacturer with designing and developing the packaging container for it.

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