1.

Introduction
Suitable methods must be applied for monitoring, and where applicable, measurement of
processes. “These methods shall demonstrate the ability of the processes to achieve planned
results. When planned results are not achieved, correction and corrective action shall be taken,
as appropriate, to ensure conformity of the product.” (see [2])

Examples of characteristics to assess the process performance or capability are or include the
following:

Capability indices Effectiveness and efficiency

Response time Use of suitable technology
Cycle time or throughput Avoidance and reduction of waste
Reliability and safety Costs
Rate of yield

2. Terms
Process
This document deals exclusively with production and assembly processes. A process is under-
stood as a series of activities or procedures in which raw materials or pre-machined parts or
components are further processed to generate a finished product.
The definition in the standard [1] is as follows: “Set of interrelated or interacting activities
which transforms inputs into outputs.”

Capability Studies
A process capability study (Process analysis, see [3]) is performed for a new or changed
production process (including assembly) in order to verify the (preliminary) process capability
or performance and to obtain additional inputs for controlling the process (see [3]).

References [10] and [11] distinguish between long-term and short-term studies. In a short-term
study (e.g., machine capability study), characteristics of products manufactured in one con-
tinuous production run are evaluated. A long-term study evaluates parts manufactured over a
longer time-span which is representative of the variation encountered in series production.

Capability and Performance Indices

Quantitative measures for evaluating capability include the machine and process capability or
process performance indices (see [4]). These must achieve or surpass the specified minimum
values.

The minimum requirements given in this manual for capability and performance indices are
valid at the time of publication (edition date). In case of conflict, the requirements of QSP0402
are binding and take precedence over this manual. Higher minimum requirements for process
capability or performance may exist for special characteristics, or may be specified internally on
a product-by-product basis.

Machine Capability Study

The machine capability study is a short-term study with the sole aim of discovering the
machine-specific effects on the production process.

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