The document discusses quality system documentation and process documentation. It defines quality system documentation and lists its common uses, such as providing understanding, training aid, auditing basis, and satisfying regulations. It also lists the typical elements that formalize a quality management system, including quality policy, quality manual, procedures, work instructions, quality records, job descriptions, and reference documentation. The document then discusses what a process is, provides a simple process model, and lists three modes for process documentation - expert, intermediate, and beginner - along with examples. It concludes by providing a template for process definition.

1. Prepared by
Ahmed Serag

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

3. Technology

4. Definition
The Organizational structure, procedures, processes and
resources needed to implement Quality management.

5. 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

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

7. Quality
Manual
Procedures
Work Instructions
Reference Documents
Quality Records (Templates)

8. Road map of the organization
Quality Evidence of commitment to quality and ability to meet specified
requirements
Manual It 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 results
Procedure Should answer the five Ws; Who, What, When, Where, Why
Work Specifies the detailed requirements for a single operation; the
tasks involved, how these should be performed and if there is a
Instructions standard to be used.
They are the forms generated by applying the procedures
Quality They demonstrate achievement of the required quality
Records Provide objective evidence on how quality system is functioning
They are simply the “output “ of the process

9.  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.

10. Activity Activity Activity Activity
1 2 3 4
Processes are how we
do work
Processes Processes
have Input Output have
Suppliers Customers
Processes use
resources
People Methods Materials Tools
Time

11. Expert Mode Intermediate Mode Beginner Mode
• Expert mode • Uses expert mode • Uses the
documentation is but add some intermediate mode
short and concise guidance documentation, but
• Made for experts adds some details
and does not contain • It needs a formal
any training training
material
• It is short.
• Its problem that not
every one is expert

12. Expert Mode
Example

13. Intermediate
Mode Example

14. 1. Purpose Why is the activity performed?
2. Activities What actions are performed?
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?
7. Roles Who performs activities?
8. Process Context Where is activity performed?
9. Sub-Activity or
procedure
How the task implemented?