Documenti di Didattica
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2
Expected Outputs
3
Course Outline
DAY 1
Terminologies on Process Approach
PDCA in Establishing a Quality Management System
Plan for the QMS
Work1: Establish ABC’s QMS Scope
Work 2: Establish PAQ’s QMS Process Map
DAY 2
Requirements of ISO 9001:2015 on Risks and Opportunities
Roles of Risks and Opportunities in Strategic Planning
Review of the Strategic Plans
Roles of Risks and Opportunities in Operational Planning
Work 3: Workshop on ROA
Presentation of Initial ROA and Critiquing
TOPIC 1. Module 1
Terminologies in Process Approach
Process
Set of interrelated or interacting activities that
use inputs to deliver an intended result.
Output
Result of a process.
Product
Output of an organization that can be produced without
any transaction taking place between the organization
and the customer.
ISO 9000:2015
Service
Output of an organization with at least one activity
necessarily performed between the organization and
the customer.
Terminologies in Process Approach
Effectiveness
Extent to which planned activities are realized and
planned results are achieved.
Efficiency
Relationship between the result achieved and the
resources used.
ISO 9000:2015
Requirements of for Process Approach
7.1.6 services
Organizational 9.3
knowledge 8.5 Management review
Production and
7.2 service provision
Competence
8.6
7.3 Release of products
Awareness and services
7.4 8.7
Communication Control of
nonconforming
outputs
7.5
Documented
information 11
PDCA as tool for Improvement
Successful
organizations
have an
ongoing
focus on
improvement.
Context of the
organization –
combination of internal
and external issues
that can have an
ISO 9001 Clause 4.1
effect on an
organization’s
approach to APPROACH IN
developing and DEVELOPING
AND ACHIEVING
achieving its OBJECTIVES
objectives.
Why Do We Need to Understand the
Context of the Organization?
To facilitate effective approach in setting and
achieving the goals and aspirations of the
organization (e.g. Vision, Objectives);
To facilitate effective approach in setting the
strategies of the organization (e.g. Strategic
ISO 9001 Clause 4.1
Secure Responsive
Stable Convenient working condition
Trustworthy Adequate incentives
Honest Effective implementation of
Prompt regulations
Efficient Service availability
ISO 9001 Clause 4.2
Vital Accessibility
Accurate Easy and orderly process
Timely Helpful and friendly staff
Automated Reliable
Modern Conscious of its role
Effectively managed
Why Do We Need to Understand the Needs
and Expectations of Interested Parties?
To have focus on establishing objectives and
performance indicators;
To determine the appropriate scope of the
quality management system;
To facilitate determination of the QMS planned
ISO 9001 Clause 4.2
results;
To facilitate determination of requirements
related to products and services;
To facilitate determination of the risks and
opportunities that need to be addressed.
Step 1.3 Establish the Scope of the QMS
covered, and
provide justification for any requirement of this
International Standard that the organization
determines is not applicable to the scope of its
QMS.
Step 1.3 Establish the Scope of the QMS
When an organization
seeks to have its QMS
certified to ISO 9001, it is
required to agree a
"scope of registration“
ISO 9001 Clause 4.3
LRA exists with the purpose to implement and protect the Torrens
system of land titling and registration, as well as registration of
transactions involving personal properties. As such, LRA is mandated
to issue decrees of registration and certificates of titles and register
documents, patents and other land transactions through its property
registration services.
Docketing &
Publication Examination Authentication
BENEFICIARIES
Entry Uploading
Payment Approval
Entry Releasing
Payment Approval
SUPPORT PROCESSES
Sample QMS Process Map
ISO 9001 Clause 4
WORK2.1: ABC’s Organizational Structure
Department Functions
results;
To facilitate determination of requirements
related to products and services;
To facilitate determination of the risks and
opportunities that need to be addressed.
Again on the Requirement of 6.1.1
Planning for
the QMS
(6.1.1)
STRATEGIC OPERATIONAL
(6.1.2)
Performance
SWOT Planning
ROA
Strategic Controls
Tactics
Directions (4.4.1f, 8.1)
47
ISO/TS 9002:2016 Basis for SWOT
OBJECTIVES 49
SAMPLE MISSION & VISION STATEMENT
MISSION STATEMENT:
To engage in the general business of integrated
logistics and trading needed or required in
carrying out the business of the corporation.
VISION STATEMENT:
To be the preferred Filipino
integrated logistics company in
the Philippines by 2020 offering
efficient, progressive and
innovative solutions for all
logistics needs. 50
SAMPLE STRATEGIES FROM SWOT ANALYSIS
VISION: INTERNAL
To be the preferred Filipino STRENGTHS WEAKNESSES
integrated logistics •Owned Assets •Timescales, deadlines and pressure.
•Strategic Location •Continuity, supply chain robustness.
company in the Philippines •Quality Processes and Procedures •Decentralize sales to develop business
by 2020 offering efficient, •Manpower with in-depth knowledge in
logistics
progressive and innovative •Ability to raise long and short capital.
solutions for all logistics •CARE Certification (Safety, Health and
Environment)
needs.
OPPORTUNITIES S/O Strategies: W/O Strategies:
•Business Expansion and Continuation
•Modernization and upgrading of •Integrated approach in business
•New Markets (ASEAN Integration)
•New Technologies equipment and infrastructure development
•Partnerships •Guarantee exceptional services and •Strengthen global partnership and
•ISO 9001 Requirements for Human deliverables network.
EXTERNAL
STRATEGIC DIRECTIONS:
1. Modernization and upgrading of equipment and
infrastructure
2. Guarantee exceptional services and
deliverables
3. Integrated approach in business development
4. Professionalize our people in terms of learning
and competency development and values
formation
5. Strengthen global partnership and network.
6. Benchmarking to close competitors
7. Maintain a healthy and safe work environment
52
Alignment of Objectives with the
Strategic Directions
Strategic Direction
Example: Maintain a healthy and safe work environment
Objective
Example: Injury free workplace
Performance Indicator
Example: Percentage of safe personnel
Planned Result
Example: 100 Percent
Tactics
Example: Conduct awareness campaign
53
Why Align the Objectives with the Strategic
Directions?
54
REQUIREMENTS ON QUALITY OBJECTIVES
55
Sample Annual Performance Plan
Injury Free Percentage of safe 100% Conduct Daily (start on Snack for P20
Work Place personnel Toolbox 1st WD of per person
meetings January 2018)
Awareness February 5, Soft and
Seminar on 2018 Hardcopies of
Injury Free leaflets
Workplace
56
Sample Annual Performance Evaluation
Ja
94% 4 4 4
n
Work Place personnel 4
Mar Feb
97% 5 4.75 4.42
5
100% 5 4 4.5
Sample Evaluation Criteria
CRITERIA DESCRIPTION
ACHIEVEMENT RATING Measure of the extent to which
(AR) planned results are achieved.
Planning for
the QMS
(6.1.1)
STRATEGIC OPERATIONAL
(6.1.2)
Performance
SWOT Planning ROA
Strategic Controls
Tactics
Directions (4.4.1f, 8.1)
63
REQUIREMENTS FOR ADDRESSING RISKS
AND OPPORTUNITIES ON PROCESSES
64
Why do we need to Address Risks
and Opportunities?
Action Intention
Address risks to •prevent, or reduce, undesired
effects
ISO 9001 Clause 6.1.1
65
Requirements on Risks and Opportunities
Requirements for Risks & ISO During which process of
Opportunities (R&O) 9001:2015 the company’s establish
Clauses QMS.
Determine R&O when planning for 6.1.1 Strategic Planning and
QMS, consider 4.1 and 4.2. Operational Planning
Plan actions to address the 6.1.2a SWOT, Performance Planning
determined R&O and Risk/Opportunities and
Actions Analysis
Plan how to integrate and 6.1.2b.1 Establishing strategic directions,
implement actions to address R&O objectives, tactics and incorporate
into the QMS processes actions on procedures
Implement the actions to address 4.4.1f Implement actions on the
the R&O processes and those that are
specified in the procedures
Implement the actions to meet 8.1 Production and service provision
requirements for products/services
66
TOPIC 2. Module 2
Risks/Opportunities & Actions (ROA) Analysis
RISKS/OPPORTUNITIES & ACTIONS ANALYSIS
Process: Material Procurement Process Owner: Material Control Department
Interested Parties – Needs & Expectations: Internal & External Issues:
•Production Department – materials are available when needed •Single source provider per critical material
•Production Control Department – adequate time to process requests •High quality performance of suppliers i.e. minimal rejects
for materials •Low delivery performance of suppliers i.e. with delays
•Material Provider – on-time and accurate purchasing information (e.g. •Good IT infrastructure i.e. connectivity
POs)
Interested parties can include the end-user, customer, function on the next process,
external provider, process owner or any entity that can affect and/or be affected by the
results of the process.
Needs and expectations can be stated, generally implied or obligatory.
The “needs and expectations” can serve as basis for identifying the “planned results”. 71
Risks/Opportunities & Actions (ROA) Analysis
RISKS/OPPORTUNITIES & ACTIONS ANALYSIS
Process: Process Owner:
Interested Parties – Needs & Expectations: Internal & External Issues:
The planned results should be aligned with the “needs and expectations”
The planned results should support the achievement of the process objectives or the function’s
MFOs and form the basis for the procedures expected outputs.
Results should be verifiable. Concrete evidence should support the attainment of the planned
results. 73
Planned Results into Expected Outputs
Risks/Opportunities & Actions (ROA) Analysis
RISKS/OPPORTUNITIES & ACTIONS ANALYSIS
Process: Process Owner:
Interested Parties – Needs & Expectations: Internal & External Issues:
Can be described as the manner in which the requirements of the process could be prevented from
fulfillment.
Risks can lead to non-fulfillment of a requirement (i.e. nonconformity)
Situation that will hinder achievement of the planned results/outputs.
Risks contributes to the “opposite” of the planned results/outputs (i.e. nonconforming outputs)
75
Consider risks during normal, abnormal and emergency situations.
Risks/Opportunities & Actions (ROA) Analysis
RISKS/OPPORTUNITIES & ACTIONS ANALYSIS
Process: Process Owner:
Interested Parties – Needs & Expectations: Internal & External Issues:
Set of circumstances which makes it possible to enhance desirable effects that could
enhance customer satisfaction or achieve improvement.
Opportunities, as exploitable circumstances, are to be translated into concrete actions
(Additional Controls column).
Opportunities can stem from risks. If this is the case, put the opportunity in the same row
76
with the risk.
Risks/Opportunities & Actions (ROA) Analysis
RISKS/OPPORTUNITIES & ACTIONS ANALYSIS
Process: Process Owner:
Interested Parties – Needs & Expectations: Internal & External Issues:
Define the existing actions or controls that prevent, detect, correct, contain or
mitigate risks.
Actions should be defined in a concrete manner and should be verifiable.
In case there is an identified opportunity, describe the existing action or control
that is subject for improvement . 77
Risks/Opportunities & Actions (ROA) Analysis
RISKS/OPPORTUNITIES & ACTIONS ANALYSIS
Process: Process Owner:
Interested Parties – Needs & Expectations: Internal & External Issues:
The analyst may opt to do a “reverse analysis” approach (i.e. describe first the
Existing Controls then work back to identify the risks being controlled
Actions entered into this column should be reflected into the documented
procedures, as applicable.
78
Risks/Opportunities & Actions (ROA) Analysis
RISKS/OPPORTUNITIES & ACTIONS ANALYSIS
Process: Process Owner:
Interested Parties – Needs & Expectations: Internal & External Issues:
Actions should be preventative in nature to eliminate or reduce the likelihood of the occurrence of
risks including its consequences/effects.
Identified actions should become part of the controls or planned arrangements of the process or
procedure.
Can trigger revision of procedures. Must have target dates and assigned person/function.
Actions should be defined in a concrete manner and should be verifiable. 79
Risks/Opportunities & Actions (ROA) Analysis
RISKS/OPPORTUNITIES & ACTIONS ANALYSIS
Process: Material Procurement Process Owner: Material Control Department
Interested Parties – Needs & Expectations: Internal & External Issues:
•Production Department – materials are available when needed •Single source provider per critical material
•Production Control Department – adequate time to process requests •High quality performance of suppliers i.e. minimal rejects
for materials •Low delivery performance of suppliers i.e. with delays
•Material Provider – on-time and accurate purchasing information (e.g. •Good IT infrastructure i.e. connectivity
POs)
82
Requirements to Integrate and Implement
Actions Into the QMS Processes
Clause Requirement
6.1.2b.1 The organization shall plan how to integrate and
implement the actions into its quality management
system processes (see 4.4)
4.4.1f The organization shall determine the processes needed
for the quality management system and their application
throughout the organization, and shall address the risks
and opportunities as determined in accordance with the
requirements of 6.1
8.1 The organization shall plan, implement and control the
processes (see 4.4) needed to meet the requirements for
the provision of products and services, and to implement
the actions determined in Clause 6
Actions into Controls in the Procedure
TOPIC 2. Module 4
REQUIREMENTS FOR ADDRESSING RISKS
AND OPPORTUNITIES ON PROCESSES
86
Risks and Opportunities Processes
Requirements for Risks & ISO During which
Opportunities (R&O) 9001:2015 process of the
Clauses company’s
establish QMS.
Plan how to evaluate the 6.1.2b.2 Performance Evaluation,
effectiveness of actions to address Internal Audit
R&O
Analyze and evaluate appropriate 9.1.3e Performance Evaluation,
data and info in order to evaluate the Internal Audit
effectiveness of actions taken to
address R&O
Review the QMS while taking into 9.3.2e Management Review
consideration the effectiveness of
actions taken to address R&O
If necessary, when NC occurs, update 10.2.1e Corrective Action (CA) on
R&O determined during planning Nonconformities
Definition of EFFECTIVENESS
“extent to which planned activities are realized and
planned results are achieved”
- 3.7.11 of ISO 9000:2015
Process
Set of interrelated or
interacting activities
INPUTS that use inputs to OUTPUTS
deliver an intended
result.
- 3.4.1 of ISO 9000:2015
89
What the Auditors should look for in a process?