Iso 9001:2015

QUALITY MANAGEMENT SYSTEM ISO 9001: 2015 Presented By: Hassan Faraz

Sequence •

•

Section – I: Basic Concepts: Quality –

Quality, Quality Assurance & Quality Control etc.

–

Cost of Quality

–

Quality Management

–

Quality Management Principals

Section – II: ISO 9001:2015 Requirements –

•

Clause by Clause (Clause 4 to 10)

Section – III: Hazard Identification, Risk Assessment & Controls

Section I Basic Concepts: Quality

What Is Quality Quality Is Conformance To Agreed Requirements How well requirements of the customer being met. (Good Quality)

How bad requirements of the customer being met. (Poor Quality)

What Is Quality? QUALITY IS CONSISTENCY OR

ABSENCE OF VARIATION OR

DOING RIGHT THE FIRST TIME OR

CUSTOMER SATISFACTION OR

MEETING SPECIFIED REQUIREMENTS

What Is Inspection or Testing To Check Whether Product / Service Has Passed The Acceptance Criteria. QC-1

Process A

QC-2

Process B

QC-3

Process C

QC-4

Quality Control (QC) Operational techniques and activities that are used to fulfill requirements for quality.

Quality Control is a Reactive approach. And it is used to verify the quality of output.

Quality Assurance (QA) “A part of quality management focused on providing confidence that quality requirements will be fulfilled” Quality Assurance is a Preventive approach, & it is used to managing for desired outputs.

Quality Assurance (QA)

4 M’s  MAN:

Training & Competence

 METHOD:

Defined & Documented, Work Study, Resource Optimization

 MACHINE: Calibrated, Preventive Maintenance (Preventive vs Breakdown) , Utilization  MATERIAL: As per defined Specs.

Quality Management (QM) Quality Management includes all the coordinated activities to

direct and control an organization with regard to quality

Cost of Quality (COQ) •

Cost of Quality ("COQ") is a measurement used for assessing the waste or losses from some defined process •

•

OR

Cost of quality is the amount of money a business loses because its product or service was not done right in the first place. •

•

OR

Variation / Inconsistency

Cost of Quality Cost of Poor Quality (CoPQ)

Cost of Quality Cost of Good Quality (CoGQ)

Cost of Quality (CoQ)

COST of QUALITY APPRAISAL COST 1. Inspection and Testing 2. Calibration of Equipment 3. Inspection of Purchased Goods 4. Quality Audit

INTERNAL FAILURE COST 1. Scrap & Rework 2. Re-testing 3. Downtime 4. Delays

PREVENTION COST 1. Quality & Process Planning 2. Preventive Maintenance 3. Training & Education 4. Supplier Evaluation

EXTERNAL FAILURE COST 1. Warranty Costs 2. Customer Complaints 3. Loss of Business 4. Returned Material / Products

Quality Management Principles

Quality Principles 4. Process Approach

Quality Management Principles Quality Principle

Benefits

Customer Focus

1. Increased Customer Loyalty Leading to repeat business 2. Increased Revenue & Market Share

Leadership

1. Motivation of people towards achievement of goals. 2. Providing people with required resources, empowerment.

Applicable Clause 5.1.2 Customer Focus

training

and

Engagement of People

1. Motivation, Commitment and involvement, of people. 2. Accountability of their performance

Process Approach

1. Lower costs & shorter cycle times through effective resource management. 2. Focusing on factors (resource, methods & material) that will improve key activities.

5.1 Leadership & Commitment 7.1.2 People 4.4.1 QMS & Its Processes

Quality Management Principles Quality Principle

Benefits

Applicable Clause

Improvement

1. Performance advantage through increased organizational abilities. 2. Flexibility to react quickly to opportunities.

10 Improvement

Evidence based Decision Making

1. Informed Decisions 2. Making decision and taking action based on factual analysis.

9.1.3 Improvement

Relationship Management

1. Increased ability to create value for both parties. 2. Clear and open communication 3. Optimization of cost and resources.

8.4 Control of externally provided product and service

Section II ISO 9001:2015 Requirements

ISO 9001:2015 Structure 4. Context of the Organization 4.1 Understanding the organization & its context

5. Leadership

5.1 Leadership & Commitment

4.2 Understanding Needs & Expectations of interested Parties

5.2 Quality/ Policy

Scope of QMS

5.3 Organizational roles, responsibilities & authorities

6. Planning

7. Support

8. Operations

9. Performance Evaluation

6.1 Action to address Risk & Competence

7.1 Resource

8.1 Operational planning & control

9.1 Monitoring, measurement, analysis and evaluation

6.2 Quality Objectives

7.2 Competence

8.2 Requirements for products & service

9.2 Internal Audit

6.3 Planning of changes

7.3 Awareness

8.3 Design & Development

9.3 Management Review

7.4 Communication

8.4 Control of Externally Provided products/ Service

7.5 Documented Information

8.5 Product & Service Provision

Quality Management System

8.6 Release of Product& Service

8.7 Control of NC

10. Continual Improvement 10.1 Nonconformity & Corrective action

10.2 Continual Improvement

Clause 4 Context of the Organization



Evaluation of the Organization

    

   



Type of the Organization. Purpose of the Organization. Size of the Business. Business Resources. Business Model. Business Boundaries. Business Opportunities. Business Operations. Business Issues. Interested Parties Requirements. Business Management.

Type of the Organization (Scope)

     

Profitable. Charity. Public. Private. Corporate. Business sector.

Purpose of the Organization (Scope)

      

Products and services. Mission. Vision. Policies. Objectives. Values. Culture.

Size of the Business (Scope)

   

Number of employees. Management sites. Functional sites. Complexity of the processes (technology, employee).

Business Resources (Scope)

 Human resources.  Infrastructure, including buildings, utilities, process equipment, monitoring and measurement equipment, work environment & raw materials.  Documented information.  Knowledge of the organization.

Business Model (Scope)



Brokerage.



Crowdsourcing.



Freemium.



Leasing.



Negative operating cycle.



Pay as you go.



Reverse auction.



Product to service.



Subscription.

Business Boundaries 

Location.



Facilities (e.g. production sites) including remote facilities which are part of the Quality Management System.

Business Opportunities 

Launching new products and services.



Opening new market.



Addressing new customers.



Building partnership.



Adoption of new technology.



Fostering new practices or standards.



Other possibilities to address customer needs.

Business Operations

Marketing

Sales

Preservation

After sale service

Design

Purchase

Documentation/Invoicing

Recycling

Production

Transportation

Disposition

Inspections

Delivery

Product Release

Payment

4 Understanding Organization & its Context 1.

External and internal issues that are relevant to its purpose and its strategic direction

2.

Needs & expectation of interested parties

3.

Scope of Quality Management System

4.

Quality management system

4.1 Understanding Organization & its Context External Issues • Political • Law & Order • Legal & Regulatory • Technological • Economic • Natural • Competitive context (International, national, regional or local)

Internal Issues • Technology • Financial • Products and services • Strategic direction • Culture • People • Knowledge • Processes • Systems

SWOT ANALYSIS

An ideal tool to meet the requirements of 4.1 clause. Strengths • Highly competent middle management • Less emissions due to clean technology

Opportunities • Government is funding the certification process for exporters • Solid waste recycling plant set by Govt. can be utilized.

Weakness • Capacity of product testing laboratory is not as per production volume • Labor is not aware of environmental issues related to their activities

Threats • Some competitors have less cost of production • Environmental Protection Agency is revising the parameters of industrial effluent

4.2 Needs and Expectation of Interested Parties The interested parties includes; •

Direct customers

•

End Users

•

Employees

•

Suppliers, Distributers, Retailers, or any other involved in supply Chain

•

Regulators

•

Any other relevant interested parties

Interested Parties Requirements Interested parties

Owners

Bankers

Leaders

Organization

Customers Society

Competitors

Suppliers

Community

Interested parties’ needs

Interested parties’ expectations

4.2 Needs and Expectation of Interested Parties Interested Parties Manager Human Resource

Requirements of QMS Provision of required Human Resources

Quality Assurance To Minimize NonDept. compliance

Needs and Expectations 1. To provide required manpower within the specified budget. 2. To ensure that employees working in the premises are competent. 3. To provide necessary trainings identified in TNA, to enhance the awareness levels. 1. Establish quality assurance program to reduce rejections and improve effectiveness 2. To identify quality issues, analyze them and take corrective actions. 3. To ensure that employees are aware of quality requirements. 4. Maintain documented information to assure quality. 5. To ensure that equipment are at their optimum condition to give desired results.

Business Management 

Business process inputs.



Business processes.



Business process outputs.

Business Process Inputs Customers requirements

Interested parties’ requirements

Applicable technical standards and codes

Business process inputs

Statuary Regulatory Requirements

Contractual Requirements

Business Management Process Management Processes Effectiveness Efficiency Profitability Sustainability

Performance measurement

Provide Leadership

Planning Processes

Improvement processes

To develop Business Plans

Business Management Processes Support Processes

Control processes

Operation Processes

Management of operations

To provide Resources

Business Process Outputs Business growth

Improved Business

Interested parties Satisfaction

Business process outputs

Profitability

Sustainability

Strategic Direction & Integration Business Objectives

Business Strategy Intended Business Results

Intended Business QMS Objectives

QMS Strategy

Strategic Direction

Internal Customer Focus

Business Objectives

QMS Objectives

Competitors Focus

Gross/Net Profit

Meeting Customer Requirements

Supplier Focus

Business Growth

Meeting Legal Requirements

External Customer Focus Business Continuity

Product and Service Conformity

Business Accountability

Customer Satisfaction

4.3 Scope of QMS While determining scope of QMS*, must consider;

a.

The external and internal issues;

b.

The requirements of relevant interested parties

c.

The products and services of the organization.

4.4 QMS & Its Processes Determine Required Inputs and Desired Outputs

Determine Sequence & Interaction of each process Determine acceptance criteria & Monitoring process Determine Resource needed

Assign responsibilities Address Risks and Opportunities Analysis, Evaluation & Improvement

Context of Organization (Clause 4) Context of the Organization Clause 4.1

Maintain documented information to support the process of its operations

Retain documented information to have confidence that processes have been carried out as per the planned arrangements

Quality Management System and its Processes Clause 4.4

Maintain documented scope of QMS

Context of the Organization Clause 4

Determining the Scope of Quality Management System Clause 4.3

Internal & external issues

Requirements of Interested Parties Clause 4.2

Requirements and expectations of the interested parties

Clause 5

Leadership

5.1 Leadership and Commitment 1 •

Communicating the Importance of QMS, Policy and objectives

2 •

Customer Focus Ensuring that customer requirements are determined, communicated and met.

3 •

Communication

Provision of Resources Management shall determine and provide the necessary resources for the QMS.

5.2 Quality Policy Policy shall ensure that it; •

Is appropriate to the purpose of the organization

•

shows top management commitment

•

Provides framework for establishing and reviewing Quality Objectives

•

Approved

•

Communicated

•

Reviewed

5.3: Organizational Roles, Responsibilities and Authorities • Defined Organizational Structure • Defined responsibilities

• Defined authorities • Communication of responsibilities and authorities

Examples:

Responsibility Matrix Job Descriptions Organizational Chart

Reference Documents Quality Policy Organizational Charts Job Descriptions Responsibility Matrix

RISK MANAGEMENT

Risk & Opportunities 

Risk is “the effect of uncertainties on the objectives”



Opportunity is “situation or condition favourable for attainment of a goal”

Risk Management Process •

Context Establishment.

•

Risk Assessment: • Risk Identification. • Risk Analysis. • Risk Evaluation. • Risk Treatment.

Based on ISO 31000.

Risk Assessment Risk assessment is the overall process of risk identification, risk analysis and risk evaluation.

Risk Analysis

Risk Identification

Risk Assessment includes: 1. Risk

Identification.

2. Risk

Analysis.

3. Risk

Evaluation.

Risk Evaluation

Risk Identification Risk identification is the process of finding, recognizing and describing risk. Note: Risk identification involves the identification of risk source, event and their potential consequences. Note: Risk identification can involve historical data, theoretical analysis, informed and expert opinions and stakeholders needs.

Risk Analysis The process to comprehend the nature of risk and to determine level of risk. Example Risk = Likelihood x consequences 5 x 5 = 25

Risk Evaluation The process of comparing the results of risk analysis with risk criteria to determine whether the risk is acceptable or tolerable.

Risk Criteria: Terms of reference against which the significance of risk is evaluated.

Risk Treatment Process of selecting and applying controls to treat risk. •

Risk Avoidance • The activity or condition that gives rise to the particular risk should be avoided. Example: eliminating the risk source or changing the process.

•

Risk Reduction • Reduce the risk by changing the likelihood or consequences of the risks.

•

Risk Acceptance • Accepting the Risk. Retaining the risk by informed decision.

•

Risk Transfer • The risk is transferred to another party that can most effectively manage this particular risk depending on risk evaluation.

Risk Based Thinking 

Risk-based problem solving (R&O identification).



Risk-based decision-making (Actions to address R&O).

Risk Based Thinking QMS Processes, Policies Information Assets Value Creation

Data Business Processes, Assets

Wisdom

Information

Knowledge

Clause 6 Planning

Actions to Address Risk Mapping of all Processes & Activities Identify the Potential Risks Associated with activities Determining Probability and Consequence Calculating Risk Factor Identification of Mitigation plan Implementation of Plan Risk factor after Mitigation

Risk Consequence can be; • Potential loss of contracts • Potential Harm to user

• Inability to meet contract / terms and requirements • Potential Violation of regulation • Impact on company’s reputation

• Est. Cost of Correction

Risk Register

QUALITY OBJECTIVES •

Objectives must be SMART

MANGEMENT PROGRAM FOR OBJECTIVES N A TIO N A L FU EL CO RPO RA T IO N

Management Program for Objectives & Targets

Rev#: 00

OBJ NO: _____________

Issue Date:

Document Code: NFC-FRM-005

DEPARTMENT: ___________________________________

TARGET DATE: ___________________

OBJECTIVE: _______________________________________________________________________________________________________________

Sr.

Action / Activity (Step by step)

Responsible Person

Give breakup of the objective in Specify form of activity for its suitable person for implementation each action.

Target Date

Resource Required (if any)

Mention Resources may tentative be mentioned completion here. date of action

Objective Setting

Current Status

This column will be used to describe the status of the action

Reference Documents

Risk Register & Risk Methodology Quality Objectives Management Program for Objectives

Clause 7 Support

7.1: Resource • The organization shall;

Determine the resources needed • Provide the resource • Maintain the resources •

It includes; • People • Infrastructure • Work environment (Physical conditions)

Organizational Knowledge • Knowledge specific to the organization generally gained by

experiences. 1. Intellectual property 2. Knowledge gained from experiences. 3. Lessons learned from past failures & successful projects (CA Log, Incident Log) 4. Standards 5. Conferences 6. Knowledge from customers or external providers

Internal Sources

External Sources

7.2 COMPETENCE • The

organization shall ensure to have competent employees to

perform task related to QMS.

Competence

Experience

Skills

Training

Education

7.2 COMPETENCE •

The organization shall provide training to achieve the necessary competence and evaluate the effectiveness of the actions taken Identify Training Needs Provide Training

Evaluate Training Effectiveness Maintain Records of Training

7.3: Awareness • Persons doing work under the organization’s control

shall be aware of; 1.

Quality policy

2.

Their roles in the QMS

3.

Requirements for organizations

7.4: Communication •Establishment of communication

system for both internal or external

Examples: • Inter office notes

• Inter office memo • Organizational Policies • Compliance board

• Notice board • Meetings • Trainings and electronic mails etc.

7.5: Documented Information Creation

Identification

Classification

Modification

Approval

Distribution

Adequate Use

Archiving

Disposal A procedure must be established to manage the document lifecycle.

Reference Documents Training Records Calibration Records Organizational Knowledge Inter Office Memo Quality Documents & Records

Clause 8 Operations

8.1: Operational Planning and Control INCLUDES:

• Determine requirements of products & services • Establish acceptance Criteria

• Determine Resources needed to achieve conformity • Implementing Controls as per specified acceptance Criteria • Maintain Documented Information

8.2.1. Customer Communication •

The company communicates with customer regarding information related to:

• Product specifications • Order and contract requirements • Customer feedback System (Improvement Suggestions) • Customer complaints System (Nonconforming Product, Late Delivery / Responses, Poor packaging, others.

8.2.3 Review Of Requirements Related To Product Review of Requirements • Define and review Customer Requirements • Analyze Organizational ability to meet the requirements • Resolve Differences & conflicts • Review of Contracts

• Maintain Documented Information

Clause 8.3: Design and Development of Product or service Design & Development Planning

Design & Development Inputs Design & Development Control Design & Development Outputs Design & Development Changes

8.4 External provision of Good & Service 1.

Define purchase requirements

2.

Product acceptance criteria

3.

Inspection of purchased product

4.

Conformance with purchase information

5.

Criteria for supplier selection

6.

Evaluation and Re-evaluation of suppliers

CONTROLS

8.5 Control of Product & Service Provision •

Product Planning & Specification

•

Availability of Work Instructions

•

Use of Suitable Equipment

•

In Process Monitoring

•

Availability of monitoring equipment

•

Maintenance of equipment

•

Production & Service provision records

Clause 8.5.2: Identification & Traceability Identification

Article #/Model #/ Item #/Design #

Traceability

Lot #/Batch #/ Serial #/Mfg. date

Inspection & Testing Status

Tags/Stickers/Trays for rejected/reworked items

8.5.3: Property belonging to customer & external providers •

It Includes;

•

Materials, components, tools and equipment, premises, intellectual property and personal data.

When the customer’s property is Lost, damaged or found to be unsuitable for use; 1. Report this to the customer or external provider 2. Retain documented information on what has occurred.

8.5.4: Preservation Identification Handling Contamination Control Packaging & Storage Protection

Transmission or Transportation

Clause 8.5.5: Post delivery activities: •

The extent of post-delivery are based on;

•

Potential undesired consequences associated with its products and services;

•

Nature, use and intended lifetime of its products and services;

•

Customer requirements; Post-delivery activities can include; 1. Warranty provisions, 2. Maintenance services, 3. Supplementary services such as recycling or final disposal.

8.6: Release of product and Service The organization shall retain the documented information on the release of product and service showing; 1. Evidence of Conformity with acceptance criteria 2. Traceability of person authorizing the release

RELEASE SLIP Date Product Batch # Batch Size Remarks Released By

8.7 Control Of Non Conforming Product a.

Correction;

b.

Segregation, containment, suspension of provision of products and services;

c.

Informing the customer;

d.

Obtaining authorization for acceptance under concession.

8.7 Control Of Non Conforming Product The documented information must be retained which; a) describes the nonconformity; b) describes the actions taken; c) describes any concessions obtained; d) identifies the authority deciding the action in respect of the nonconformity

Reference Documents Customer Feedback and Complaints Supplier Evaluation forms Acceptance Criteria

Corrective Action Forms QC Reports & Release label

Clause 9 Performance Evaluation

Customer Satisfaction 1.

Customer surveys

2.

Customer feedback (on delivered products and services)

3.

Meetings with customers

4.

Market-share analysis

5.

Complaints

6.

Warranty Claims

7.

Dealer reports.

Analysis & Evaluation • Conformity of products and services; • Degree of customer satisfaction; • Performance and effectiveness of the quality management

system; • Effectiveness of actions taken to address risks and opportunities; • Performance of external providers; • Need for improvements to the quality management system.

9.2: Internal Audit The organization shall conduct internal audits at planned intervals to review the effectiveness of QMS. The audit programme include;

9.3: Management Review MRM consideration: a)

Status of actions from previous management reviews;

b)

Changes in external and internal issues that are relevant to the quality management system;

c)

Effectiveness of the quality management system

(Customer Satisfaction, NC,

Corrective actions etc.)

d)

Audit results;

e)

Performance of external providers;

f)

Adequacy of resources;

g)

Effectiveness of actions taken to address risks and opportunities

h)

Opportunities for improvement.

Reference Documents Customer Feedback and Complaints

Internal audit records MRM Records Analysis reports

Clause 10 Improvement

Nonconformity & Corrective Actions Nonconformity

Correction

Corrective Action (CA)

Root Cause Analysis

Corrective Action Taken Deal with Consequence

Review of Effectiveness

Update Risk & Opportunities Maintain Documented Information

Maintain Documented Information

Continual Improvement Quality Objective s

Management Review

Correctiv e Actions

Data Analysis

Quality Audits

Hazard Identification, Risk Assessment and Controls •

Establish, implement and maintain procedures for ongoing hazard identification, risk assessment and determining necessary controls.

•

Take into account Routine and non-routine activities • Activities of all persons having access to workplace • Human behavior, capabilities and other human factors • Hazards outside of workplace but under control of organization • Infrastructure, equipment and materials at workplace • Design of workplace, processes etc. •

Hazard •

Source, situation, or act with a potential for harm in terms of human injury or ill health, or a combination of these.

Types of Hazards •

Following are major types of hazards; •

Physical

•

Chemical

•

Biological

•

Psychological

•

Ergonomic

Physical Hazards •

Physical Hazards include; • • •

• • • • • •

Noise Vibration Lighting Electrical Heat / Cold Dust Fire/Explosion Machine Moving Parts Working Space

Chemical Hazard •

Chemical Hazards include; • • •

•

Gasses Fumes Vapours Liquids

Biological Hazards •

Biological Hazards include; • •

•

Infections (bacterial/viruses) Allergic Response Ingested (via contaminated food)

Psychological Hazard •

Psychological Hazards include; • • •

• •

Shift work Workload Harassment Discrimination Stress

Ergonomic Hazard •

Ergonomic Hazards include; • • •

• •

Tool design Equipment design Job and Task Design Workstation design Manual Handling