Objective: by considering clauses 8.1-8.

4
Outcomes: by considering clauses 8.1-8.4
Claus Objective/Outcome Pre-training Method Content Aid/ Evaluation Ti
e for trainer Exampl me
e
8.1 The trainees will be able to: Brainstorming Ask them whether they remember From
Opera 1.Plan, implement, and control Read clause what they learned in clause 6 as best Making them practice what
tional the process of their own 4.4 and they have learned by
organization clause 6 well as clause 4.4 practice
plann forming group, taking one
ing 2.Plan to control the planned s: Use
and changes and determine how to Explain 8.1a & or more organizations, and
contr respond to any changes ask the following question:
Lecture -planning process, implementing 8.1b
ol 3.relate clauses 4.4 and 6 with
the planned process and 1. Why does an organization
clause 8.1
4. explain the necessity of the controlling the implemented need processes?
maintaining document process 2. Take one organization
concerning the clause. and show the planned
-the ideas reflected in clause 4.4
and clause 6. changes of the organization
-how to respond to planned and and how to respond to the
unplanned changes changes.
8.2 The trainees will be able to: Brainstorming Making them practice what
Requir 1.identify the type of Understand From they have learned by
ements
communication the organization and consider Lecture best forming group, taking one
for
should consider relating to the pre- practice or more organizations, and
produc
ts and product and service requirements determined Explain: s: Use ask the following question:
service 2.determine the requirements of applicable -the nature of the customer 8.2a & 1. Take one Service
s products and services statutory communication. 8.2b organization, and list the
3.understand the importance of and -how to determine the statutory and regulatory
reviewing products and services regulatory requirements for products and requirements applicable to
requirements requirement services, and the importance of it.
s reviewing the requirements. 2. Take one Production
-the importance of retaining organization, and list the
documented information statutory and regulatory
concerning review results, new requirements applicable to
requirements, changes etc it.
8.3 The trainees will be able to: Brainstorming From Making them practice what
Design
and 1.establish, implement and Have a list best they have learned by
develo maintain a design and of Lecture practice forming group taking one or
pment
of
development process for participants Give explanation on: planning, s: Use more organizations, ask the
produc products and services and their input, control, output and changes 8.3a & following question:
ts and
2. Explain considerations that respective of design and development of 8.3b Take one organization and
service
s must be made concerning
organization products and services. explain briefly the
planning, input, control, output
. consideration concerning:
and changes of design and
1.Planning,input
development of products and
2. control, output
services.
3.Changes

8.4 The trainees will be able to: Read clause Brainstorming Give explanation on: From Making them practice what
1. determine the controls to be 4.4 and -how to determine controls for best they have learned by
Contro applied to externally provided other Lecture externally provided processes, practice forming group taking one or
l of processes, products products and services conform to
and services relevant requirements. s: Use more organizations, ask the
externa
lly 2. analyze the coherence of materials -type of the information that must 8.4a & following question:
provid externally provided processes concerning be communicated to external 8.4b 1.What does an organization
ed with QMS of their organization QMS providers do to select an external
proces 3. determine the information to processes. providers?
ses, be communicated to external 2.What does an organization
produc
providers. communicate to its external
ts and
service providers?
s
Examples
8.1a

8.1 Operational planning and control

Training Content
Before starting the training, read clause 4.4 and clause 6 to understand the requirement of establishment of processes and how to plan
them. As a brainstorming, ask them whether they remember what they learned in clause 6 as well as clause 4.4. Based on their
responses, revise some major points reflected under those clauses so that the trainees make themselves ready to understand operational
planning and control.
Answers
Clause 8.1
1.
2.
3.

Clause 8.2
1.
2.
3.
Clause 8.3
1.
2.
3.
Clause 8.4
1.
2.
3.
Topic: Clause 8.1 Operational planning and control
Objective :
Method
Aid/Example
Content