Professional Documents
Culture Documents
C
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responsibility s
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Resource
Measurement, c
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improvement
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m ne m
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Input
realization Output
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6. Resource Management
6.2.1 General
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6. Resource Management
(Contd.)
6.2 Human Resources
6.2.2 Competence, Awareness and Training
The organization to
• Determine necessary competence for personnel performing
work affecting product quality,
• Provide training or take any other actions to satisfy these
needs***,
• Evaluate effectiveness of the actions taken.***
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6. Resource Management
(Contd.)
6.2 Human Resources (Contd)
6.2.2 Competence, Awareness and Training
(Guidelines)
Make employees at each relevant function level aware of
• importance of conformance with the Quality Policy & QMS
requirements
• significant impacts of their work activities on quality, actual or
potential
• benefits of improved personnel performance
• roles and responsibilities in achieving conformance to quality
policy
• the potential consequences of departure from specified
procedures
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Changes in ISO-9001-2008
Paragraph 6.2
Words, "affecting product quality" changed to "affecting
conformity to product requirements”
Paragraph 6.2.2
Sub-clause (b) -"provide training or take other actions
to satisfy these needs" changed to "where applicable
training needs to be provided to achieve the
necessary competence".
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4.4.2 Training Awareness &
competence
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Effectiveness
Extent to which planned activities are realized and planned
results achieved.
ISO 9000:2000 3.2.14
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7. Product Realization (Contd.)
7.3 Design & Development (D/D)
7.3.1 Design and Development Planning
• Plan and control Design and Development of the product
• During planning, determine
• Stages of design and development
• Review, verification and validation appropriate to each
Design and Development stage
• Responsibilities and authorities for Design and Development
• Manage interface between different involved groups to ensure
effective communication and clear responsibilities
• Update planning output, as appropriate, as Design and
Development progresses
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7. Product Realization (Contd.)
7.3 Design & Development (D/D) (Contd)
7.3.2 Design & Development Inputs
❚ Determine the inputs related to product
requirements and maintain records
❚ Design & Development inputs to include
❙ Functional and performance requirements
❙ Applicable statutory and regulatory requirements
❙ Where applicable, Information derived from previous
similar designs
❙ Other requirements essential for Design and Development
❚ Review inputs for adequacy. Requirements to be
complete, unambiguous and non-conflicting
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7. Product Realization (Contd.)
7.3 Design & Development (D/D) (Contd)
7.3.3 Design & Development Outputs
❚ Outputs of D/D provided in a form that enables
verification against D/D inputs. This shall be
approved prior to release
❚ D/D Outputs shall :
❙ meet D/D input requirements
❙ provide appropriate information for purchasing,
production and for service provisions
❙ contain or reference product acceptance criteria
❙ specify product characteristics essential for safe and
proper use
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7. Product Realization (Contd.)
7.3 Design & Development (D/D) (Contd)
7.3.4 Design & Development Review
❚ At suitable stages, conduct systematic D/D reviews
❙ to evaluate the ability of results of D/D to fulfill requirements
❙ to identify any problems and proposed necessary actions
❚ Involve and include representatives of functions concerned with
design stage(s) being reviewed
❚ Records of results of reviews and necessary actions to be
maintained
7.3.5 Design & Development Verification
❚ Perform verification to ensure that D/D outputs have satisfied D/D
input requirements
❚ Records of results of verification & necessary actions to be
maintained
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7. Product Realization (Contd.)
7.3 Design & Development (D/D) (Contd)
7.3.6 Design & Development Validation
❚ Perform D/D validation in accordance with planned
arrangements (see 7.3.1) to ensure
❙ Resulting product is capable of fulfilling the requirements
for the specified or known intended use or application
❚ Wherever practicable, validation to be completed prior
to delivery or implementation of the product
❚ Records of results of validation and necessary actions to
be maintained
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7. Product Realization (Contd.)
7.3 Design & Development (D/D) (Contd)
7.3.7 Control of Changes
❚ Changes in D/D to be identified and records
maintained
❚ The changes to
❙ be reviewed, verified and validated, as appropriate
❙ be approved before implementation
❙ include evaluation of the effect of changes on
constituent parts and delivered products
❚ Records of the results of validation and
necessary actions to be maintained
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Training Evaluation
6 - 19
How the training is evaluated?
Widely known
Simple framework
The advantages:
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Key features of ISO 10015
1. Linking training investment with company
performance
• Key client is the organization, not only the persons being trained.
(ROI Approach)
• A company has to recognize first what is the performance challenge
it faces and the causes for it.
• ISO 10015 offers a clear road map to connect training to
performance goals and use it for individual and group performance
improvement.
2. Organizing training on the basis of pedagogical
principles and processes
• Training as a tool to cover an identified performance gap.
• Establishing an appropriate training design and effective learning
processes.
• Ensures that training uses resources (finances, time and energy)
optimally.
Training: for organizational needs
4.1Training is 4-step
process
For selecting and implementing training to
close the gaps between required and
existing competence, management should
monitor the following stages:
a) defining training needs;
b) designing and planning training;
c) providing for the training;
d) evaluating the outcome of training.
The Training Process
4.2 Defining Training
Needs
4.2.1 General
4.2.2 Defining the needs of the
organisation
4.2.3 Defining the competence needs
4.2.4 Reviewing Competence
4.2.5 Defining Competence gaps
4.2.6 Identifying solutions close to
competence gaps
4.2.7 Defining the specifications for
training needs
Training Processes-1
Training Processes-2
Training Processes-3
Training Processes-4
4.3 Designing and planning training
4.3.1 General
4.3.2 Defining the constraints
4.3.3 Training methods and
criteria for their selection
4.3.4 Training Plan specifications
4.3.5 Selecting a training provider
4.4 Providing the training
4.4.1 General
4.4.2 Providing Support
1. pre-training support
2. training support
3. end-of-training support
4.5Evaluating training
outcomes
4.5.1 General
4.5.2 Preparing evaluation report
Contents of evaluation report:
– specification of training needs
– Evaluation criteria and description of
sources, methods and schedule for
evaluation.
– Analysis of data and interpretation
– Review of training costs
– Conclusions and recommendations for
improvement.
5 Monitoring and improving the training
process
5.1 General
5.2 validation of training process
Monitoring is the key tool:
– Monitoring is to be done by competent personnel
only.
– Monitor records at all stages. Detect nonconformity
at all stages. Take preventive and corrective
actions.
– if procedures followed and requirements met, then
update the personal competence records.
– if procedures not followed yet requirements are
met, revise procedures and update training records.
– If procedures followed and requirement not met,
either correct the training process or seek a non-
training solution.
• Identify further opportunities for improvement.
Thank
You