Prepared byAhmed Serag

Introduction What is Process Simple Process Model Documentation Framework Process Documentation Usage Modes Process Elements Process Definition Template Questions

Technology

DefinitionThe Organizational structure, procedures, processes and resources needed to implement Quality management.

Quality system documentation should be used for several purposes:

Provide a mean to understand the system As an Aid for training Provide an understanding of the requirements to act as instruction As a basis for auditing To satisfy external regulations

The documentation formalizes the QMS are: Quality Policy Quality Manual Procedures Work Instructions Quality Records Job Description Reference Documentation

Quality Manual

Procedures

Work Instructions

Reference Documents

Quality Records (Templates)

Quality Manual

Procedure

Work Instructions

Quality Records

Road map of the organizationEvidence of commitment to quality and ability to meet specified

requirementsIt contains Quality Policies, processes and the interaction between theses processes

It describes the purpose of the process.What happens over the time to produce a desired resultsShould answer the five Ws; Who, What, When, Where, Why

Specifies the detailed requirements for a single operation; the tasks involved, how these should be performed and if there is a standard to be used.

They are the forms generated by applying the proceduresThey demonstrate achievement of the required qualityProvide objective evidence on how quality system is functioningThey are simply the “output “ of the process

A process is a group of activities, not just one. The activities that make up a process are not random or

ad hoc; they are related and organized. All the activities in a process must work together

toward a common goal. Processes exist to create results your customers –

whether they’re internal or external.

Activity 1

Activity 2

Activity 3

Activity 4

People Methods Materials Tools

Time

Input OutputProcesses

have Customers

Processes use resources

Processes have

Suppliers

Processes are how we do work

Expert Mode

•Expert mode documentation is short and concise

•Made for experts and does not contain any training material

• It is short.• Its problem that not

every one is expert

Intermediate Mode

•Uses expert mode but add some guidance

Beginner Mode

•Uses the intermediate mode documentation, but adds some details

• It needs a formal training

Expert Mode Example

Intermediate Mode Example

1. Purpose Why is the activity performed?

2. Activities What actions are performed?

7. Roles Who performs activities?

3. Input(s) What work products are used?

4. Output(s) What work products are produce?

5. Entry Criteria When does the activity begins?

6. Exit Criteria When does the activity ends?

8. Process Context Where is activity performed?9. Sub-Activity or procedure How the task implemented?