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[Full Client Name Reg Caps] Procedure: [Process Definition Doc Title]: Name of Process Here Rev. [Rev Number]
NOTE: you must create one Process Definition document for
[Process Definition Doc Title]: Name of Process Here
each of the top-level processes identified in the manual.
1. SUMMARY 1.1. This document defines the [name of process here] process in detail. 1.2. The relationship between this process and the other processes within the [Short Client Name] [Q uality ity Manual D oc management system is illustrated in the process flow map included in the [Qual
Title]. 2. REVISION AND APPROVAL Rev.
Date
[Rev Number]
[Date of Issue]
Nature of Changes
Approved By [Procedure Approver Name]
Original issue.
3. PROCESS DEFINITION 3.1.
The purpose of the [process name here] is to [define its purpose here. This is a rough overview of what the process is intended to achieve].
4. PROCESS OBJECTIVES AND METRICS 4.1. Process objectives for this process are defined in records of management review; see the [Manag ement ement Review P roc. Title]. Title]. documented procedure [Manag 4.2.
In addition, each objective has at at least one metric (or KPI) with which management can measure the effectiveness of the process. These are also defined in records of management review.
5. PROCESS OWNERS AND RESPONSIBLE PARTIES 5.1. The owner of this process is [who?]. 5.2. Describe any additional responsibilities and authorities for this process here. 6. TYPICAL PROCESS INPUTS 6.1. The typical required inputs for this process are: 6.1.1. Technical information needed:
6.1.2. Resources needed:
6.1.3. Personnel needed: Page 1 of 2
[Full Client Name Reg Caps] Procedure: [Process Definition Doc Title]: Name of Process Here Rev. [Rev Number]
6.1.4. Special training needed:
7. TYPICAL PROCESS STEPS 7.1.
Here define the process steps. You may elect to do so using text, or a process map.
8. TYPICAL PROCESS OUTPUTS 8.1. The typical results (outputs) of the process are as follows: 8.1.1. Product produced:
8.1.2. Documents or technical information produced:
8.1.3. Records produced:
8.1.4. Services produced:
9. RELATED RISKS 9.1. The following risks are identified related to this process. (edit table as required) 9.2. Management may elect to conduct a formal risk assessment for any of these risks; the preferred method of risk assessment is indicated herein. Risk
