Product realization

The standard requires the supplier to have a process for product realization to deliver products on time to customer requirements including product design where applicable. 

Product realization in the automotive industry is either called advanced product quality planning (APQP) or project management. In terms of their objectives there is no difference. In terms of the mechanics there may be some differences, depending on the methodologies employed by the organization. 

The standard requires that if a project management approach is used, a project manager and project team be assigned, that appropriate resources be allocated, and any special responsibilities and organizational interfaces be defined. 

In some respects this requirement is ambiguous as there are no equivalent requirements for when the APQP approach is used. The APQP manual merely offers guidance. With the APQP approach the equivalent of the project manager is the project team leader and the equivalent of the project team is the product quality planning team. 

It is suggested that the project organization be described in the quality plan regardless of whether an APQP or project management approach is used. (See Part 2 Chapter 1 for a discussion on resource documentation.) 

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Measurement and review of product realization stages Use of common tools for FMEA, SPC, MSA... 

Requirement for measurements at appropriate stages of product realization to be defined, analyzed, and reported... 

Requirement for the status of product realization to be reviewed at appropriate stages... 

Requirement for audit of product realization and production processes to determine the effectiveness of process performance... 

Are multidisciplinary teams employed to manage product realization and production phases ... 

Will the processes for product realization consistently deliver conforming products on time to customers ... 

Reporting product realization measurements to management (clause 4.2.4.2) Conducting project reviews (clause 4.2.4.3)... 

The standard requires that measurements be defined, analyzed, and reported to management at appropriate stages of product realization and that these measurements include quality risk, costs, lead times, critical paths, and others as appropriate. 

The standard requires the use of a multidisciplinary approach to prepare for product realization including development and review of special characteristics, FMEA, and control plans. 

The standard requires the supplier to establish and maintain documented procedures to develop and verify the design of processes used for product realization. 

This requirement applies to the processes used in product realization, production, installation, and servicing and hence is not intended to be applied to management and procurement processes. 

Establish a product realization process that covers the phases from product conception to product approval. 

How do you manage the product realization process so that it delivers products and processes that meet customer requirements ... 

What approach do you take to manage product realization ... 

The standard also requires that the instructions be derived from appropriate sources, such as the quality plan, the control plan, and the product realization process, which means that all instructions should be traceable to one or more of these documents. They should form a set, so that there are no instructions used outside those that have been approved by the planning team. This is to ensure that no unauthorized practices are employed. Another important aspect to consider is the use of informal practices - practices known only to the particular operator. Process capability should be based on formal routines, otherwise repeatability cannot be assured when operators change. 

This clause requires the designation of special characteristics that should have been accomplished during product realization (as required by clause 4.2.4.7). As for the documentation of special characteristics, the symbols should have been applied both when establishing the process controls and preparing the control plan (also clause 4.2.4.7) and associated documentation during the planning phase. Therefore the requirements not previously addressed are for the control of special characteristics and evidence of compliance i.e. quality records. 

Planning of Product Realization (Plan and develop processes to produce product)... 

The product realization is the main part of the QMS activity. Product realization in the case of a laboratory is the process of performing the analysis. 

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