4.20 Statistical Techniques r2



ISO Procedure

Statistical Techniques

Approved: __________________________________________________

title Name

Approved: ___________________________________________________

title Name

Approved: __________________________________________________

title Name

Approved: __________________________________________________

title Name

Approved: __________________________________________________

title Name

Change Record

|Rev |Date |Responsible Person |Description of Change |

|A |- |Name |Initial Release |

Distribution List

(list the departments that receive controlled copies)

1. Purpose

• To ensure consistent quality and appropriate process control through the use of statistical techniques.

• To collect, analyze, and interpret data relating to product and process performance.

2. Scope

This procedure applies to data gathered from process, shipment, and inspections; and from marketing analysis.

3. Responsibilities

collects data from in-process tests.

samples the quality of received product.

identifies all critical process control points and statistical methods to be employed.

collects test results from barcode readers.

4. Procedure

4.1 Applications

The following table lists the inspections or tests from which data is analyzed:

Test or Inspection Name Responsible Person Collection Method

|(i.e., receiving inspection) |(i.e., inspector) |(i.e., visual) |

|(i.e., inprocess) |(i.e., operator) |(i.e., test equipment) |

| | | |

| | | |

|(i.e., Final system test) |(i.e., Manufacturing Engineer) |(i.e., Software) |

4.2 Process Analysis

The following table with the types of analysis, test, and record keeping:

Types of analysis Tests /inspections Forms used to record data

providing data

|(i.e., first pass yield, burn-in failure | | |

|rates, Pareto, histogram) | | |

| | | |

| | | |

| | | |

| | | |

The following table lists the person responsible for data collection, frequency, and method:

Test Responsible Person Frequency Collection Method

| | | | |

| | | | |

| | | | |

reviews and analyzes the data. The data is disseminated by .

4.3 Data Review

collects data. , at attended by the data and causes of problems and corrective actions are reviewed.

4.4 Market Analysis

collects marketing data through . reviews the marketing data.

4.5 Written Procedures

documents the procedures for collecting and analyzing statistical data. These procedures are maintained under the Document Control system.

5. Related Documentation

Contract Review

Process Control

Inspection and Testing

Servicing

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