ISO presentation

ISO/DIS 9001 (9001:2015)AWARENESS PRESENTATION

8/26/2015Mohammed Fakhruzzaman, Head of Team (QA)

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OBJECTIVES

At the end of this training program Participant should be able to:

Understand ISO 9001 is a good management tool

Understand all activities to be managed and controlled in a systematic way to keep things in order


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WHAT IS ISO 9001?

ISO = International Organization for Standardization

9001 = unique ID number

2015 = Year published


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Formation 23 February 1947Type NGOPurpose Int’l standardizationHQ GenevaMembership 63 countriesWebsite www.iso.orgNo. of stds over 18,000

WHAT IS ISO 9001

Based in Switzerland

Made up of over 160 national standards bodies

Almost 20,000 standards in the ISO portfolio

All standards are based on international consensus

ISO standards are usually developed by its technical committees (TC) and sub-committees (SC)

ISO/TC176/SC2 (quality systems) is responsible for 9001


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WHAT IS ISO 9001


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YEAR STANDARDS TITLE

1959 MIL‐Q‐9858 QUALITY PROGRAM REQUIREMENTS

1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS

1974 BS 5179 GUIDELINES FOR QUALITY ASSURANCE

1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING

1987 ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing

ISO 9002:1987 Model for quality assurance in production, installation, and servicing

ISO 9003:1987 Model for quality assurance in final inspection and test

1994 ISO 9001:1994 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE

2000 ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS ‐ REQUIREMENTS

20082015

ISO 9001:2008 ISO 9001:2015

QUALITY MANAGEMENT SYSTEMS‐ REQUIREMENTSQUALITY MANAGEMENT SYSTEMS‐ REQUIREMENTS

WHAT IS ISO 9001?

It’s a quality management system that can be adopted by any organization.

The system is focused towards the meeting of customer requirements and enhancing of customer satisfaction


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Keywords: 1. Quality2. Management system3. Customer requirements4. Customer satisfaction5. Risk & Opportunity6. Leadership7. Identify, Monitor ,measure &

improve8. Corrective action

WHAT IS ISO 9001 QMS - REQUIREMENTS?

Quality = degree to which customer requirements are met

Management = Plan &coordinated activities to direct and control an organization

System = Set of interrelated or interacting processes for achieving desired objectives

Quality management system = a system to direct and control an organization to meet customer requirement

Requirements = a set of management parameters


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7 QUALITY MANAGEMENT PRINCIPLES (THESE ARE EVALUATION CRITERIA FOR FBEA)


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The ISO 9001 Stadard is based on these principles

SL # ISO 9001:2008 ISO 9001:20151 Customer Focus Customer Focus2 Leadership Leadership3 Involvement of People Engagement of people

(competent & empowered)4 Process approach Process approach5 System Approach to management6 Continual improvement Improvement7 Factual approach to decision

makingEvidence based decision making

8 Mutually beneficial supplier relationship

Relationship management

3 Core Concepts• Identify the processes needed to achieve the planned results• Continually monitor the risks (Risk-based thinking Cause & effect,

FMEA)• Manage the processes and the system using “PDCA”Will improve the process by removing the following waste

Ineffectiveness

Inefficiencies

Problems/Errors

Inconsistencies

Malicious practices

Uncertainties

Bad culture


ADVANTAGE Assist management to identify the potential risk and opportunity for improvement Providing confidence to interested parties as to the consistency, effectiveness. Provide senior leadership to identify efficient management process for effectiveness Provide guidance to Highlights process deficiencies through internal audit. Remove ambiguity from the processes Sets out areas of responsibility across the organization Communicates a positive message to staff and customers Provide understanding of CAR when NON-CONFORMANCE arises from the expected process

outcome Marketing opportunities Improved communication, planning and administration processes Provide guidance to monitor, measure and improve the process. Mandatory to tender for some public sector work


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ADVANTAGE

Improved quality and service

Delivery on time

Right first time attitude

Fewer returned products and complaints

Independent audit demonstrates commitment to quality


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DISADVANTAGE

Most of us does not have an adequate understanding of ISO

Think ISO implementation is require for ISO accreditation purpose only.

Lot of paper work


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ISO 9001 ACCREDITATION Perform by independent Certification Body, such as BSI, BVQI, SGS, etc.

Organization gets 3 years renewable certificate

Stage 1 audit = Adequacy audit = Documentation audit

Stage 2 audit = Conformance audit = Physical audit of personnel, records and processes to be conducted within 4 months of stage audit

First year = Certification audit

2nd year = Surveillance audit

3rd year = Surveillance audit and/or re-certification audit

Note: If after 3 months, nonconformities were not corrected (via the corrective action procedure) by the organization, the ISO 9001 certificate will be revoked by the Certification body


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STRUCTURE OF ISO 9001 PDCA

8/26/2015Mohammed Fakhruzzaman, Head of Team (QA)14

SCOPE OF ISO 9001

1. Demonstrate ability to consistently provide product that meets

o customer and

o applicable statutory and regulatory requirements, and

2. aims to enhance

o customer satisfaction through the effective application of the system, including processes for continual improvement of the system

o assurance of conformity to customer and applicable statutory and regulatory requirements.


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WHY ISO 9001 IS CHANGING

All ISO management system standards are subject to a regular review under the rules by which they are written.

Integrate with other management systems

Revision of the 8 quality management principle

Provide an integrated approach to organizational management

Provide a consistent foundation for the next 10 years

Reflect the increasingly complex environments in which organizations’ operate

Ensure the new standard reflects the needs of all potential user groups

Enhance an organization’s ability to satisfy it’s customers.


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WHAT ARE THE SIGNIFICANT PROPOSED CHANGES IN ISO 9001:2015?

The key changes in the proposed standard for 2015 based on ISO/DIS9001 Standard, published in May 2014, are:

The emphasis on leadership

The focus on risk management

Emphasis on objectives, measurement and change

Communication and awareness

Fewer prescriptive requirements. (refer to hard copy for details ) Significant change.docx


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DEFINITION OF PROCESS


PROCESSINPUT OUTPUT

“set of interrelated or interacting activitieswhich transforms inputs into outputs”

• Production Processes (PD,Cutting,sewing, Pressing & packing)

• Management Processes (administration, audits, CAR, HR)• Support Processes (maintenance, warehouse, purchasing, QA)• Customer Processes (Merchandising, Planning)

ISO 9001:2015 STRUCTURE

Clause 1 Scope

Clause 2 Normative references

Clause 3 Terms and definitions

Clause 4 Context of the organization

Clause 5 Leadership

Clause 6 Planning for the QMS

Clause 7 Support

Clause 8 Operation

Clause 9 performance evaluation

Clause 10 Improvement8/26/2015Mohammed Fakhruzzaman, Head of Team (QA)

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Structure of ISO 9001:2015

4 Context of organization

Understanding of the organization and its context

Needs & Expectations of interested parties

Scope of the QMS

QMS and its Processes

5 Leadership

Leadership and commitment

Quality policy

Roles, responsibilities and authorities

6 Planning

Actions to address risk and opportunity

Qualityobjectives

7 Support

Resources

Competence

Awareness

Communication

8 Operation

Operation planning and control

Determination of requirements for products/ services

Design and development

Control of externally provided products and services

9 Performance evaluation

Monitoring, measurement, analysis and evaluation

Internal audit

Management review

10 Improvement

PLAN DO CHECK ACT

Documented information

Planning of changes

Production & service provision

Release of products and services

Control of Nonconforming process outputs, products and services

Continual improvement

Nonconformity and corrective action


4 CONTEXT OF THE ORGANIZATION

Determine the external and internal issues relevant to organization’s purposeo strategic direction and the achievement of customer satisfaction.

o the needs and expectations of interested parties relevant to the QMS

Prepare a schedule of reviewing and monitoring those on a regular basis. Determine the scope of the QMS taking the external and internal issues,

interested parties and products and services? Establish QMS processes needed and their sequence and interaction. Set criteria for managing those are established to ensure the effective

operation and control together with o responsibilities, o methods, o measurements ando related performance indicators needed to ensure the effective operation and

control?


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LEADERSHIP

Ensure top management taken accountability for the effectiveness of the QMS.

Formulate the policy and objectives for the QMS, compatible with the strategic direction of the organization are established and communicated.

Establish quality objectives at relevant departmental , sectional and individual levels with the business?

Integrate QMS requirement into the business processes and promote awareness of the process approach throughout the organization/process?

Ensure customer requirements and applicable statutory and regulatory requirements are determined, met and communicated throughout the organization?

Establish the risks and opportunities that are relevant to the QMS

Establish & communicate the responsibilities and authorities for the effective operation of the QMS?

Ensure job responsibilities are understood by the relevant person.


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PLANNING

Address the risks and opportunities to give assurance that the QMS can achieve its intended result(s)

Plan actions to address these risks and opportunities and integrated them into the system processes?

Define process for determining the need for changes to the QMS and managing their implementation?


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QUALITY POLICY

In quality management system, a quality policy is a document jointly developed by management and quality experts to express the quality objectives of the organization, the acceptable level of quality and the duties of specific departments to ensure quality.


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DQ

S-UL

Managem

entSystems

Solutions©

Notable Changes

PROCESSINPUT OUTPUT

P-D-C-AISO9001:2008 Preventive

Action


DQ

S-UL

Managem

entSystems

Solutions©

Notable Changes

PROCESSINPUT OUTPUT

P-D-C-AISO9001:2015

Risk Based Thinking


SUPPORT Determine and provide the resources (people, environment and infrastructure) needed for

the o establishment,

o implementation,

o maintenance and

o continual improvement of the QMS

When monitoring or measuring is used for evidence of conformity of products and services to specified requirements, determine the resources needed to ensure valid and reliable monitoring and measuring of results?

determine the knowledge necessary by implementing lesson learnt processeso for the operation and its processes

o achievement of conformity of products and services

Ensured that persons who can affect the performance of the QMS are competent on the basis of appropriate education, training, or experience or taken action to ensure that those persons can acquire the necessary competence?

Has the documented information required by the standard and necessary for the effective implementation and operation of the QMS are established? 8/26/2015Mohammed Fakhruzzaman, Head of Team (QA)

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OPERATION Define process for the provision of products and services that meet customer

requirements

Planned changes are carried out in a controlled way and take action to mitigate any adverse effects.

Are any outsourced processes managed and controlled?

Define process for reviewing and communicating with customers in relation to products and services, enquiries, contracts or order handling?

Define “review process” prior to the commitment to supply products and services?

When design and develop products or services, establish and implement the processes in line with the requirements of the standard?

Ensure that externally provided processes, products, and services conform to specified requirements?

Establish criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers?


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OPERATION Provision of products and services carried out in controlled conditions which include:

o the availability of documented information that defines the characteristics of the products and services;

o the availability of documented information that defines the activities to be performed and the results to be achieved.

o monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met?

o the people carrying out the tasks are competent?

Ensure having effective methods traceability during the operation process?

Property belongs to customers or external providers is controlled effectively

Identify & define post-delivery activities associated with the products and services such as warranty, maintenance services, recycling or final disposal.

Identify & manage “nonconforming process” outputs to prevent unintended use.


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PERFORMANCE EVALUATION

Determineo what needs to be monitored and measured and

o the methods for monitoring , measurement , analysis and evaluation, to ensure valid results

Establish schedule for monitoring and measurement for analyses and evaluation

Establish the methods of monitoring customer perceptions of the provision of products and services

Determine the need or opportunities for improvements within the QMS and identify the method for management reviews?

Established a process for an internal audit of the QMS?

Establish & implement an approach to perform management reviews


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IMPROVEMENT

Determine and select opportunities for improvement

Implement necessary action to meet customer requirements and enhance customer satisfaction

Establish appropriate processes for managing nonconformities and the related corrective actions?.

Decide & establish method of addressing the requirement to continually improve the suitability, adequacy, and effectiveness of the QMS?


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ACTION PLAN to implement

ISO 9001:20158/26/2015Mohammed Fakhruzzaman, Head of Team (QA)

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Identify required processes that determine departmental performance

Set KPI from each process outcome inline with DFL Quality policy

Identify risk associated with those processes and make action plan

Monitor , measure and analyse those processes through process audit

Improve.


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ADAPT WITH CHANGE MANAGEMENT

Formula for change : D X V X F > resistance to change

D (Dissatisfaction)- unhappy with the current situation

V (Vision) - desire to get solution

F (First) – First, concrete steps taken towards the vision

If the product of above three factors is greater than

R = Resistance to Change- Everything/Everyone against the change

Then change is possible. Above 3 factors are multiplied and if any factor is absent or low then we would not be overcome the resistance.


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EQUATION OF CHANGE OR DIMENSION OF CHANGE


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Vision + Skills + Incentive + Resource + Action plan = Change

x + Skills + Incentive + Resource + Action plan = Confusion

Vision + x + Incentive + Resource + Action plan = Anxiety

Vision + Skills + x + Resource + Action plan = Gradual change

Vision + Skills + Incentive + x + Action plan = Frustration

Vision + Skills + Incentive + Resource + x = Wrong start

APPROACH TO PROCESS

Process: A set of INPUT that transforms a specified set of OUTPUT QUALITY must be managed by a SYSTEM SYSTEM must be managed using the PROCESS APPROACH PROCESSES are linked to each other A process has inputs , resources, activities, outputs and customers. OUTPUT of one PROCESS is a INPUT for next process


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APPROACH TO PROCESS

QUALITY usually judged by Outcomes

When OUTCOME fails to meet expectations we often point to workers motivation & inadequate effort

Quality problem in one process are often due to deficiency of one or more system related process or failure in coordination of interrelated processes.

If the processes are deficient the outcome will likely be a deficient.

Poor quality is often the result of poor job design or failure of leadership to provide a clear purpose for activities


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APPROACH TO PROCESS

Input = requirements ( Related to efficiency

Output = product or service ( related to effectiveness)

Product or service = result of a process

Process = a set of inter-relating activities produce output


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input process output

APPROACH TO PROCESS

Every process require specific inputs, resources, activities, outputs and customers

“The process approach introduces horizontal management, crossing the barriers between different functional units and unifying their focus to the main goals.”

What we can do now is: Define and document the INPUT,RESOURCES, ACTIVITIES, RESPONSIBILITIES and OUTPUTS of

the identified PROCESSES.

We can name this document as ……..Department Control Plan

Execute this plan, and monitor, measure, analyze and improve its performance (KPI)

Thus, Plan – Do - Check – Act (Edward Demmings)


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BENEFITS OF APPROACH TO PROCESS


Benefits of the process approach are:

Enables expected outcome achievement by Integrating & aligning the processes.

focus on process effectiveness. Provide confidence to customers, and other interested parties. Transparency of operations. create shorter cycle times lowering cost, through removal of ambiguity. Improve consistency and predictable outcome. Focus on opportunities prioritize improvement initiatives. Encourage people involvement and clarification of their responsibilities.

RISK BASE THINKING

Risk base thinking is something we all do automatically

Risk base thinking is part of the process approach

Risk base thinking helps us seeing positive side of risk

Risk base thinking help us identifying opportunity for improvement

Risk base thinking prioritizing the risk to be acted on

Risk base thinking build a strong knowledge base

Risk base thinking establishes a proactive culture of improvement

Risk base thinking increases the probability of reaching

objectives

Risk base thinking makes prevention a habit


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THINGS TO DO FOR RISK ANALYSIS


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Identify what our risks and opportunities are for the dept./organization as per business context –

Analyse and prioritize risks & opportunities

Plan action to address the risk

Check the effectiveness of the actions- does it works

Improve

Conduct FMEA Analysis ..\Risk analysis\Risk analysis template.xltx

RISK ANALYSISPERFORMING A RISK ANALYSIS ON BUSINESS PROCESSES CAN DETECT POTENTIAL NONCONFORMITIES

Describe the risk

Describe the potential effects

Quantify likelihood of occurrence (consider frequency)

Quantify severity of consequence (consider harm or damage)

Assign risk rating (likelihood x severity)

Risk rating > 4 shall be controlled (ALARP = as low as reasonably practicable)


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Score ratings1 = very low2 = low3 – moderate4 = high5 = very high

Z:\QUALITY MANUAL\ISO\RISK ANALYSIS\RISK ANALYSIS TEMPLATE.XLTX


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Personnel performing work affecting conformity to product requirements

- shall be competent on the basis of appropriate o education,

o training,

o skills and

o experience.


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Establish Job Description

Hire /Train employee

Appraise performance

Identify training needs

Conduct training

Assess effectiveness

of training

PLAN DO CHECK ACT

KEY PERFORMANCE INDICATORSAsk this question when

determining KPI’s:Being a LEADER of the

department/ organization, what data will instantly give us overall performance of any process at any given point of time?

List all them down to BSC and select desired KPI’s.


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Balanced scorecard

Financials

Processes

Customers

Human capital

Create a survey may contain the following: 1. Employee’s name2. Job position3. List of routine activities4. List of non-routine activities5. Key performance indicators6. Skills required7. Competency assessment per skill (use score

ratings)8. Recommendation for training

Employees fill Leaders fill Benefits: Leaders can identify work

redundancies, activity gaps, competency gaps, need for training and maybe the need to re-engineer the work processes

Output: ?8/26/2015Mohammed Fakhruzzaman, Head of Team (QA)

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Sometimes, work activities are not defined. So there’s a lot of confusion

Defining staff duties and responsibilities and analyzing training needs to ensure competence is essential

ENSURE ALL EMPLOYEE

Know our Quality Policy

Aware on their roles and understand the importance how their contribution leads to the achievement of quality objectives

Comply with the requirements of the Processes, Procedures and Work instructions etc.

Provide feedbacks or ideas about the QMS

Report any nonconformities


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MONITOR AND MEASURE?

If we cannot measure it, we cannot improve it. Lord Kelvin

Measurements provide us a baseline to improve upon.


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WHAT DO WE MEASURE?

1. Customer satisfaction (Survey, returns rate, complaints, lost business, etc)

2. Process conformance and effectiveness (internal audit)

3. Process performance (Key Performance Indicators and quality objectives)

4. Product characteristics (QC inspection before release to customer) where nonconforming products must be controlled


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WHAT TO DO : AUDIT PROCESS

Purpose is to verify whether QMS

a) Conforms to Quality Plan,b) Conforms to ISO 9001 requirements,c) Conforms to your QMS requirements, andd) is effectively implemented and

maintained.


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Establish al audit

schedule

Distribute Audit Plan

Perform audit

Report findings

Follow-up actions

AUDIT DEFINED

documented process for gathering audit evidence

Criteria is set of policies, procedures or requirements

Evaluate findings against the audit criteria to determine whether it has been fulfilled (create checklist)

Audit evidence is records, statements of fact or other information relevant to the audit criteria and verifiable

Audit conclusion is the outcome of an audit provided by the audit team after consideration of the audit objectives and all findings


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What to ask? What records to inspect? What activities to observe? What action taken against the identified risk and

what are the improvements

1. Verify conformance and effectiveness against a specific requirement.

2. That requirement may come from the ISO 9001 Standard, your Quality Manual, SOP, etc.

3. Answer depends on what audit criteria want to verify

4. look for the audit evidence5. Use the ISO 9001 Audit Checklist and start

auditing.


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Audit methodologya) Interviewing the

auditeeb) Inspection of

documents and records, etc.

c) Observation of ongoing activities

5S (..\5S


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MATURITY LEVEL

LEVEL 5 Focus on Prevention

Employees are continually seeking improvement opportunities.

##

Anyone can walk into the work area and easily locate items. Abnormal conditions are visually obvious and corrective action measures are in place.

##

Area employees have devised a dependable and documented method of preventive cleaning and maintenance. Work area cleanliness and organization are a way of life.

##

Employees are continually seeking the elimination of waste, all changes are documented and information is shared with employees.

##

Employees maintain consistent standards in compliance with the 5S program. ##

LEVEL 4 Focus on

Consistency

A dependable documented method has been established to maintain things free of unnecessary items.

##

A dependable and documented method has been established to recognize, with a visual sweep, if items are out of place or exceed quantity limits.

##

5S schedules detailing tasks and responsibilities are understood and practiced.

##

Workplace method improvements are visible and understood by all employees. ##

Checklists exist showing that employees follow through on 5S schedules.

##

LEVEL 3 Make It Visual

All unnecessary items have been removed.

##

Designated locations are marked to make things

##

5S schedules detailing tasks and responsibilities are developed and utilized. ##

Method improvements are being incorporated and documented. ##

5S schedules detailing tasks and responsibilities have been developed and are utilized.

##

LEVEL 2 Focus on Basics

Necessary and un-necessary items are separated. ##

A designated location has been established for all items. ##

Things are cleaned on a regularly scheduled basis.

##

Methods are being improved, but changes have not been documented.

##

A recognized effort has been made to improve the condition of the work environment.

##

LEVEL 1 Just

Beginning

Necessary and unnecessary items are mixed together. ##

Tools, supplies, books and materials, process procedures, workinstructions are randomly located.

##

Things are dirty or disorganized.

##

No attempt is being made to document or improve current processes. ##

Minimal attention is spent on housekeeping.

##

SUSTAINSORT SET IN ORDER SHINE STANDARDIZE

NONCONFORMITIES

Don’t avoid because

Detecting & actioning on root cause will STOP them recurring.

Document the solution for QMS requirement.All Non conformance to QMS & Process failure

require Corrective action.


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CORRECTIVE ACTION PROCESS


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Detect nonconformity

Report nonconformity

Review nonconformity against criteria

Issue CARPerform root cause analysis

Evaluate need for corrective

action

Implement corrective

action

Record the results of

actions taken

Verify effectiveness of actions taken

WHAT TO IMPROVE?

continually improve the effectiveness of the QMS through the use of the Risk analysis, quality policy, quality objectives, audit results, analysis of data, corrective actions and management review.

All nonconformities require corrective actions


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WHAT TO ANALYZE?

Analyze what is measured:a) Customer satisfaction levelsb) Internal audit resultsc) Product QC inspection resultsd) KPI resultse) Suppliers’ performance.


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HOW DO WE ANALYZE? Line Chart/Trend Chart/Control Chart – to detect trends and unusual activities within the

data set, Pareto Chart Analysis – to analyze the different components that make up the data

value in a descending order, complete with the cumulative percentage line superimposed on it

SWOT Analysis - to analyze process strengths, weaknesses, opportunities and threats based on the characteristics of the data set - whether internal or external,

Arithmetic average or mean – to Identify the average performance value of the process, Median - to identify the actual middle value of the data set, Mode - to identify the most frequent value occurring within the data set, Range - to identify the difference between the lowest and highest values , Standard deviation – to identify the SD from the mean Cause and Effect Analysis – To analyze the causes and effects of a given data set, Risk Analysis - To identify potential risks given the data set using FMEA method


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TREND CHARTUSE IT TO IDENTIFY POTENTIAL PROBLEMS

0

5

10

15 Errors What


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PARETO PRINCIPLE (80/20 RULE)

80% of value is achieved with the first 20% of effort

"80% defect is produced by 20% of causes"

"20% of the tools in a toolbox are used in 80% of tasks"

Identify and classify all problems

Calculate cumulative occurrences

Focus on solving those problems

Continually improve the management of those causes


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ROOT CAUSE ANALYSIS AS PER DFL METHOD ..\..\..\FZAMAN\LEARNING RESOURCE\PROBLEM SOLVING METHOD\DANAM PWS


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RISK RADAR (..\RISK ANALYSIS

Current Average

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5S + Safety FY05 Perfromance Trend

Goal Rating


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