Clause 7.1 Planning of product realization

“Hollywood... was the place where the United States perpetrated itself as a universal dream and put the dream into mass production.”

Angela Carter (English writer, Writing from the Front Line) 

Sequence of processes and sub-processes required to achieve the product is called product realization.

This requirement is about controlling operations. An organization needs to ensure that all activities take place under controlled conditions. In other words: operations must be organized in such a way that the customers are provided with the products or services that they want.

Most organizations already have their operations well organized. The best indicator for this is the fact that most of their customers are satisfied with the product they get. However, the key word here is consistency. Controlled conditions imply that an organization is consistently providing products that meet customer's expectations.

Therefore, activities need to be documented. However, it is important to realize that it is not necessary to document all activities. It is only important to document an activity if the absence of such a procedure would adversely affect quality. It is useless to create a procedure for a chef that explains how to cook, for a surgeon that explains how to operate, or for a truck driver that explains how to drive. If there is a problem in this area, it is probably better to consider training. Rather, documented procedures should focus on those activities that require coordination and communication, or that are dependent on critical data and information. For example: a procedure may describe the sequence of certain operations, or may include acceptance criteria and tolerances.

While a lack of documented procedures may result in inconsistencies and misunderstandings. It is important to consider that too many procedures will not be effective either. Over documentation can easily result in unnecessary bureaucracy or inflexibility. The number and type of procedures should be dependent on the size and complexity of the organization. A small distributor with only a few employees will likely have very simple and straightforward documentation, while a large nuclear plant may need very sophisticated procedures in order to keep their operations under control. Organizations need to identify the activities for which instructions are necessary and then document them.

Clause 7.1 is the base clause for product realization where we determined need and extent of application of other sub-clauses within clause 7. Here consideration is given to over all system as defined in clause 4.1, clause 1.2 where exclusions are permitted within clause 7.

Standard requires organizations to determine:

• Product Objectives
• Requirements for the product
• processes, documents, resources specific to product
• required verification, validation, monitoring, measurement, inspection and testing to meet product requirements
• records (4.2.4) to provide evidence of compliance to requirements

A word about flexibility:
It is not the existence of procedures that will create either flexibility or inflexibility but how they are documented.

Procedures

Procedures can take many forms: work instructions, operator instructions, flow charts, checklists, or even pictures or videos. Each organization needs to determine which format (s) will meet its needs best. In any case, a procedure and its format should be practical and easy to understand by the people who use it. Before creating any procedures, it is always an idea to consider the documentation that is already in place. This documentation may go a long way in meeting the requirements of ISO 9001.

Though clause 1.2 states that any requirement within clause 7 can be excluded, I do not see any situation where clause 7.1 can be excluded. Clause 7.1 is base clause and asks to determined product realization cycle considering requirements of clause 7.2, 7.3, 7.4, 7.5 and 7.6.
Similarly clause 7.5.1, also, can not be excluded because 7.5.1 demands defining control of production and service provision. The requirements within 7.5.1 are to be applied if applicable to product or service

External Document Reference: Documentation Kit

Product Realization cycle