Overview of ”Lean” (JMD)

Notes (2011) are based on ”Lean Production Simplified”, 2nd ed.

by Pascal Dennis

Dennis Chapter 2The LEAN Production System

• Look at the basic elements in Figure 2.4 (page 19) and 2.5 (page 20).

• Core goal is customer focus• Muda = waste

– Actual work – adds value to the product– Auxiliary work – supports the actual work– Muda – activity that creates no value. Test: if you stopped

doing this, there would be no adverse effect on the product.– Types of Muda – motion, waiting, conveyance, correcting,

overprocessing, overproduction, inventory, knowledge disconnection

LEAN

• Lean is about reducing muda. Overproduction is a most serious waste that leads to the other wastes.

• Mura – unevenness or fluctuation of work, caused by fluctuting production plans.

• The lean system seeks to reduce mura through heijunka or production leveling

• Muri – means hard to do, caused by variations in production, poor job design or ergonomics, poor part fit, inadequate tools or jigs, unclear specifications, etc.

• See figure 2.8 (page 26) for relation. Think about a system for the lego-production example. What could have worked better?

Dennis Ch. 2 - Stability• 5S and TPM are two keys to achieving production stability. • 5S is a system of workplace organization and standardization whose goal is

to support visual management. Visual management means managing by exceptions. Out-of-standard conditions should be immediately seen and corrected.

• 5S leads to TPM. In Total Productive Maintenance - Production team members are involved in basic maintenance activities.

• TPM targets the 6 big losses that afflict equipment. • Machine Loss Pyramid – highlights importance of identifying hidden and

minor losses early on, by involving production team in checking &

improving equipment performance.

Visual Management

• Seeing as a group• Knowing as a group• Acting as a group

The 5S system is (page 31):Sort – Set in order – Shine (and inspect) –

Standardize- Sustain

Dennis Ch3. -Total Productive Maintenance (TPM)

• TPM represents a shift from ”I operate, you fix” to ”We are all responsible for our equipment, our plan, and our future.” The target is zero breakdowns.

• Figure 3.2 (page 40)• Key measures – availability, performance efficiency, and

overall equipment effectiveness (OEE). Accurate data is essential (MTBF, MTTR)

• 6 big losses (page 41) – breakdowns, setup delays, idling, reduced speed, process defects and reduced yield.

The Machine Loss Pyramid• Breakdown means function loss• Minor stoppage means function reduction• Minor failfure means substandard condition that causes

function loss• Hidden failure means a condition that leads to minor failure• See figure 3.4 (page 43). Breakdowns are the tip of the

iceberg. Prevention of the higher levels are done by preventing failures at the lower levels.

• ”Minor anomalies” – fail to attract our attention. TPM is looking for anomalies, and taking action before breakdown.

Dennis Ch4. - Standardized Work

The ”industrial engineering” assumptions:1. There is a single best way2. Workers are not involved in the designing of the work

or maing improvements3. Standards are rarely changedOld concept was to maximize the utilization of machines.

New concept is to maximize the utilization of people.Lean system develops people-centered processes. The

measure of efficiencty is labor density.Labor density = Work/Motion

Why standardized work?

1. Process stability – repeatability, meet targets every time.2. Clear stop and start points for each process. Know the pace of

production, know if ahead or behind.3. Organizational learning – knowledge in the organization, not

with the person only.4. Audit and problem solving – can assess and identify problems,

checkpoints, easy to track5. Employee involvement and poka-yoke – team members develop

standardized work6. Kaizen – standardized work provides baseline against which we

measure improvement7. Training- workers more easily respond to changes in demand.

Elements of Standardized Work

• Takt time = how frequently we must produce a product = Daily operating time/Required quantity per day

• Takt time should sync with cycle time. Cycle time = actual time it takes to do the process.

• Work sequence – what is the best way to do the process? (posture, etc.)

• In-process stock – how much inventory should be there? Requires to know work-in-process standards per process.

Charts used to define standardized work

• Production capacity chart (page 55) – determine capacity of the machines in process

• Standardized work combination table (page 56) – Shows work elements, their sequence, time per each, operator and machine time, interactions.

• Standardized work analysis chart (page 57) – Showes work layout, process steps and times, critical quality, safety items, standardized WIP stock.

• Job element sheets (JES)– A job element is the minimum action or group of actions required to advance a

process– JES are one-page that define: actions making up the job element, rationale,

photos of key points, revsion record.• How to measure Time – breaking the process into elements. Noting the

start and stop time of each element. (p.58 – steps)

Overall Efficiency

• Efficiency = Output/Manpower• Overall efficiency involves all the processes• Some processes will be harder than others. The

challenges are: identify the bottlenecks, decide how to exploit the bottlenecks, elevate the bottlenecks by allowing the team members to help each other.

• Identifying Kaizen (small improvement) opportunities – use guidelines (p.62) for motion, layout, grips. (Use of layout – cells, p. 63-65).

Elements of JIT Manufacturing

• Inventory reduction exposes problems• Kanbans & pull production systems• Small lots & quick setups• Uniform plant loading• Flexible resources• Efficient facility layouts

Role of Inventory Reduction

• Inventory = Lead Time (less is better)• Inventory hides problems

The Pull System

Number of Kanbans Required

N = number of containersD = demand rate at the withdraw stationT = lead time from supply station C = container sizeS = safety stock

C

SDT N

containerskanban 4.425

10(200)(.5)

C

SDTN

bottles 10.5)0.10(200)(d)(T)0.10(deman S

containerper bottles 25C

hour .5minutes 30T

hourper bottles 200D

:Solution

Computing the Number of Kanbans: an aspirin manufacturer has converted to JIT manufacturing using kanban containers. They wish to determine the number of

containers at the bottle filling operation which fills at a rate of 200 per hour. Each container holds 25 bottles, it takes 30 minutes to receive more bottles, safety

stock is 10% of demand during LT.

Small Lot Sizes & Quick Setups

• Small lots mean less average inventory and shorten manufacturing lead time

• Small lots with shorter setup times increase flexibility to respond to demand changes

• Strive for single digit setups- < 10 minutes• Setup reduction process is well-documented

– External tasks- do as much preparation while present job is still running

– Internal tasks- simplify, eliminate, shorten steps involved with location, clamping, & adjustments

Uniform Plant Loading

• A “level” schedule is developed so that the same mix of products is made every day in small quantities

• Leveling the schedule can have big impact along whole supply chain

Monday Tuesday Wednesday Thursday FridayAAAAA BBBBB BBBBB DDDDD EEEEEAAAAA BBBBB BBBBB CCCCC EEEEE

Monday Tuesday Wednesday Thursday FridayAABBBB AABBBB AABBBB AABBBB AABBBBCDEE CDEE CDEE CDEE CDEE

5 units5 units10 units

Weekly Production Required

Traditional Production Plan

JIT Plan with Level Scheduling

ABCDE

10 units20 units

Flexible Resources

• Moveable, general purpose equipment:– Portable equipment with plug in power/air– E.g.: drills, lathes, printer-fax-copiers, etc.– Capable of being setup to do many different things with

minimal setup time

• Multifunctional workers: – Workers assume considerable responsibility– Cross-trained to perform several different duties– Trained to also be problem solvers

Effective Facility Layouts

• Workstations in close physical proximity to reduce transport & movement

• Streamlined flow of material• Often use:

– Cellular Manufacturing (instead of process focus)– U-shaped lines: (allows material handler to quickly drop

off materials & pick up finished work)

Traditional Process Focused Layout

• Jumbled flows, long cycles, difficult to schedule

JIT Cellular Manufacturing

• Product focused cells, flexible equipment, high visibility, easy to schedule, short cycles

JIT and TQM- Partners• Build quality into all processes• Focus on continuous improvement - Kaizen• Quality at the source- sequential inspection• Jidoka (authority to stop line)• Poka-yoke (fail-safe all processes – device that allerts

operator that an error has occured.)• Preventive maintenance- scheduled• Work environment- everything in its place, a place

for everything

Respect for People: The Role of Employees• Genuine and meaningful respect for associates• Willingness to develop cross-functional skills• Actively engage in problem-solving (quality circles)• Everyone is empowered• Everyone is responsible for quality: understand both internal

and external customer needs • Associates gather performance data• Team approaches used for problem-solving• Decisions made from bottom-up• Everyone is responsible for preventive maintenance

The Role of Management• Responsible for culture of mutual trust• Serve as coaches & facilitators• Support culture with appropriate incentive

system including non-monetary • Responsible for developing workers• Provide multi-functional training• Facilitate teamwork

Supplier Relationships and JIT• Use single-source suppliers when possible

• Build long-term relationships

• Work together to certify processes

• Co-locate facilities to reduce transport if possible

• Stabilize delivery schedules

• Share cost & other information

• Early involvement during new product designs

Benefits of JIT • Smaller inventories• Shorter lead times• Improved quality• Reduced space requirements• Lower production costs• Increased productivity• Greater flexibility

Implementing JIT• Implementation needs a designated “Champion”• Make quality improvements- all processes O-P• Reorganize workplace

– Remove clutter & minimize storage• Reduce setup times• Reduce lot sizes & lead times• Implement layout changes

– Cellular manufacturing & close proximity• Switch to pull production• Extend methods to suppliers

JIT in Services• Most of the JIT concepts apply equally to Service

companies• Cellular layouts, product focused, & flexible

employees shorten response times • Service inventory, “paperwork”, should be

eliminated, simplified, examined for “waste”• “Fail-safe” all processes from Orders-Payment• Team based organizations

Summary of Ch 5• TQM concepts incorporate JIT manufacturing • Team based work systems, empowerment,

cross-functional flexibility, with appropriate reward systems are all part of JIT.

• Most of the JIT concepts are equally applicable to “Service Organizations.”

• JIT requires changes to be made in all functional areas and examination of all processes for waste.

Jidoka – (from Dennis Chapter 6)

• Jidoka : “built in quality”• The zero defect philosophy • Autonomation• Andon• Pokayoke• Maintenance system

Jidoka : “built in quality”

“ It refers to the ability of the production lines to be stopped in the event of such problems as equipement malfunctions, quality problems or work being late, either by machines which have the ability to sense abnormalities or by workers who pusheda line-stop button. Preventing, in this way, the passing of the defects, recoccurence prevetion becomes simpler as abnormalities becomes more obvious, making it possible to “built in quality at the production process”.At the same time, since defects are prevented automatically, inspectors become unnecessary, which in turn in significant labor savings.”

The zero defect philosophy :

- Stopping the process to built in quality- Pokayoke, Andon, Problem solving...- “Keep it simple...”- Procedure and standards built for operation...

Autonomation

« Autonomation describes a feature of machine design to effect the principle of jidoka used in the Toyota Production System (TPS) and Lean manufacturing. It may be described as "intelligent automation" or "automation with a human touch."[1] This type of automation implements some supervisory functions rather than production functions. At Toyota this usually means that if an abnormal situation arises the machine stops and the worker will stop the production line. Autonomation prevents the production of defective products, eliminates overproduction and focuses attention on understanding the problem and ensuring that it never recurs. It is a quality control process that applies the following four principles:

Detect the abnormality. Stop. Fix or correct the immediate condition. Investigate the root cause and install a countermeasure. »

Autonomation

This illustration shows how a limit switch stops Operation #10 when the transfer conveyor has five pieces.

Andon

« An electrical Board which lights up to show at a glance the current state of the work operations. Andon boards allow speedy corrective action to be taken by supervisors when a problem araises,

Besides indicating abnormal situations sone Andon provide work instructions (such as quality checks, change of cutting tools, and conveyance of parts) and job progress information.”

Visual control example

Andon

8. Jidoka

Andon

Pokayoke

Examples of poka-yoke in consumer products include: Automatic transmissions: the inability to remove a car key from the ignition switch of an

automobile if the automatic transmission is not first put in the "Park" position, so that the driver cannot leave the car in an unsafe parking condition where the wheels are not locked against movement. (This is an example of ).

3.5" floppy disks: the top-right corner is shaped in a certain way so that the disk cannot be inserted upside-down.

High-security padlocks: it is impossible to remove the key from some high-security padlocks unless the shackle on the padlock is closed. Only by locking the padlock can the key be removed. Security mistakes/accidents are therefore much less likely to occur, particularly where the padlock key is kept on a chain attached to someone's belt. This is because the design ensures that a key cannot easily be left in an unlocked padlock, or a padlock left unlocked after opening it, or not fully closing the shackle of a padlock. Each of these three scenarios would be dangerous in high-security scenarios such as military installations, armories, prisons or bonded warehouses. In contrast, most standard-security padlocks do allow a key to be removed from a padlock, regardless of whether the shackle is closed or not.

Examples of poka-yoke in consumer products include:

UK 13 amp electric plugs: it is impossible to wrongly insert the plug into the socket, due to its arrangement of three rectangular pins.

Microwave ovens: a door switch automatically disconnects the activation button when the door of the oven is opened. As a result, it is impossible to cook anything in a microwave oven unless the door (which contains a Faraday cage to block microwaves) is fully closed. If it were possible to activate an oven with the door open, this would allow dangerous leakage of high intensity microwave radiation, which would be very harmful to any living creatures in the immediate area.

SIM (Subscriber Identity Module) cards: The SIM card used in cellular phones has its upper left corner trimmed diagonally to guide the card correctly into position.

Pokayoke

Pokayoke

JIDOKA video

http://www.youtube.com/watch?v=JSQ0WfY86k0

Chapter 8 – Hoshin Planning (Dennis)

Strategic Planning - Strategic Planning is focused on answering the questions:

A. Who are we?B. Where are we?C. Where do we want to

go?D. When do we want to be

there?E. How do we get there?

• One of the keys to effective planning that Hoshin attempts to address is how to keep your plans from ending up in a binder on the shelf collecting dust. The picture of the aligned arrows and arrows in disarray on page 126 gives a great visual of what effective planning can do for an organization. How do we develop, communicate, and implement strategic initiatives with flexibility and buy-in throughout the organization? Most of us can probably think of examples where the goals of top management are not aligned with the various departments and activities.

Hoshin planning

• Five steps to becoming a learning organization can be tied to Hoshin planning.

1. Personal Mastery2. Mental Models3. Shared Vision4. Team Learning5. Systems Thinking

• Key steps in Policy Deployment of the Hoshin Planning System are:

1. PDCA2. Process cycles (Figure 8.6)3. Catchball4. Pacemaker (Control dept,

p.132)5. A3 Thinking

PDCA• PDCA refers to Deming’s

Plan-Do-Check-Act cycle. A simple application to strategic deployment might look like:

• Plan -Reduce average cycle time by 10% during the year

• Do-Make the parts• Check-Reduced cycle time by

8%. Did not accomplish. • Act-Continue team activities

to review and modify the process.

• Process refers to 3 concurrent PDCA cycles. As analogy one can visualize a series of shafts and gears working in harmony.

• On the top level was a large shaft spinning slowly. This shaft represents the organization and its long term plan. It contains the vision for PQCDSM. (productivity, quality, cost, delivery, safety, morale)

• A series of gears connected the top shaft to a series of parallel shafts spinning at a faster rpm. These shafts represented the various divisions and their 1-year plans for achieving PQCDSM.

PQCDSM• Another series of gears connected

these to numerous smaller shafts on the third level that represented the day-to-day activities of the individual departments and temporary teams all trying to accomplish PQCDSM. While some of them might be temporarily inactive for various reasons (teams that completed their project), most of them are making a humming sound spinning at very high rpm’s as they focus on accomplishing the 1-year plan that is being driven by the long term plan. Lines of communications between the three shafts provide feedback to the higher levels to adjust their focus if necessary.

• Figure 8.6 on page 128 shows his version in a flow chart form that shows the closed-loop design of the 3 cycles interacting with each other.

• Dennis mentions Nemawashi, “to prepare a tree for transplanting” (p.130) This implies group consensus about the plan of action, and is really the outcome of the catchball process.

Catchball and Pacemakers• Catchball is described on page

130 and is the communications and give-and-take back and forth within management to gain understanding and buy-in to the objectives and goals. Have you ever seen or heard a goal from someone higher up that you or other key people were unaware of? Worse yet, have you ever heard of one that key people don’t agree with? Obviously, these situations aren’t conducive to high performance.

• Pacemakers are departments that align activities by leading the process, making the process visible, coordinating solutions, and building required management systems. These can be traditional departments such as Engineering or positions that many of us are unfamiliar with such as Value Stream or SQDC Managers (Safety, Quality, Delivery, Cost). This is the control department concept, pp. 131-132.

A3 Thinking• A3 Thinking combines scientific

methods with “telling the story”. It can be used for planning, problem solving, proposals and summarizing current status of conditions. Combining with the “Tools of Quality” can increase the effectiveness of the presentation. Dennis discusses the benefits of standardizing and shortening reports.

• Departmental scoreboards can display departmental metrics and summaries to drive their performance. Visualizing their plan and activities makes it is easy for staff and management to get a feel for what they are doing and verify their alignment with top level activities.

• To make Hoshin Planning work, it is important that managers do not accept their leader’s Hoshin without questioning. Leaders should not attempt to deploy without verifying their subordinates understanding and support of the plan. Review of the plans on a routine basis is critical to their success. Dennis shared his amazement the first time he was informed that he had a bi-monthly 2 hr. Hoshin review scheduled with his superior, Mr. Cho. Obviously, their plans weren’t going to sit on the shelf and collect dust. Hoshin follow through can also be audited as part of the PDCA check process.

Telling stories with A3 Thinking Example of a Problem solving A3

Hoshin Planning - Tools• The following is a summary from an

early book published in the states (1989) on Hoshin Planning that focused on various tools that could be used to facilitate the Hoshin process and organizational performance. It is a slightly different definition to Hoshin that we read in Dennis.

• Similar to Maslow’s Hierarchy of Needs, the Hoshin process developed the Organizational Hierarchy of Needs. Success requires moving from the bottom level (5) to the top (1).

1. One Vision2. Alignment3. Self-Diagnosis4. Process Management 5. Target Focus Alone (leads to

misaligned operations)

• The steps in the Hoshin cycle include:1. Vision (Hoshin generation)2. 1 Yr Plan3. Deployment (individual &

alignment) (Hoshin deployment)4. Execution (process management)

(Hoshin implementation)5. Monthly Diagnosis (Hoshin

evaluation)6. Annual Diagnosis

• It is important to remember that this is a cycle, so the diagnosis steps will come prior to the vision and 1 year planning steps as we repeat the process.

Quality Tools

• It is important to remember that this is a cycle, so the diagnosis steps will come prior to the vision and 1 year planning steps as we repeat the process.

• There are 3 sets of tools to assist with the process. They are:

– 7 Tools of Quality– 7 Management Tools– Alignment Tools.

• The “7 Tools of Quality” are designed to perform analysis where quantifiable data exists. Kaoru Ishikawa is generally given credit for advancing the 7 Tools of Quality in a formalized problem solving discipline. Of the 7 Tools, the Fishbone Chart to assist with root cause analysis is the only tool that he developed. Even though there have been several tools added to the arsenal of problem solving tools, and sometimes the list of “7 Tools“ slightly varies, some of them are:

• 1. Check Sheet, 2. Scatter diagrams, 3. Histograms, 4. Pareto analysis, 5. Process Flow Chart, 6. Fishbone chart, 7. Control Chart

Managment Tools and Alignment ToolsThe planning process often involves analysis of thoughts

and ideas that are not easily quantifiable. To assist with this analysis are the 7 Management Tools. They are:

• Affinity Diagram (KJ analysis) – Gathers large amounts of data (thoughts) and organizes it into groupings based on the natural relationship between each item.

• Interrelationship Diagraph – Explores and displays interrelated factors involved in complex problems. Shows the relationship between problems.

• Tree Diagram – Systematically maps out the full range of tasks / methods needed to achieve a goal.

• Matrix Diagram – Displays the relationship between necessary tasks and people or other tasks, often to show the responsibility for the task.

• Matrix Data Analysis – Show the strength of the relationship between variables that have been statistically determined.

• Process Decision Program Chart (PDPC) – Maps out every conceivable event that may occur when moving from a problem statement to the possible solutions.

• Arrow Diagram – Used to plan the most appropriate schedule for any task and to control if effectively during its progress.

Another set of tools are called the “Alignment” tools. Their purpose is to help align strategy between functions (processes) and levels. Among these are:

• Flag system – Shows how key actions (means, policies) of each manager can be aligned to support key directions (targets) of the organization. Can be shown as a tree or series of charts aligned sided by side.

• Target / Means - Shows the relationships between targets and means to identify control items and methods. Generally formatted on tree or systems chart.

• Quality Function Deployment – Matrix that translates customer requirements into technical requirements at different stages of product development and production. Often referred to as the “House of Quality”.

• Proper use of these three sets of tools can improve the development, alignment, deployment, execution and diagnosis (Plan-Do-Check-Act) of the organization’s strategic and operational plans plan. You don’t have to use all the tools all the time. Like golf, you just need to know how different clubs can be used, and determine which one will get the job done.

Dennis (Ch 9) The Culture of Lean &

Own summary on Quality Management Systems

Toyota’s LEAN Culture

• Day-to-day behavior– Plan-do-check-act (PDCA)– Standardization– Visual Management– Teamwork– Paradox– Intensity– The “do” (path) concept

Chapter 9 - The Culture of Lean Production• During the book we reviewed Dennis’s

House of Lean. There can be other Houses of Lean that are similar but a little different in their interpretation.

• Different people have different interpretations of Lean. But there is a robustness of Lean tools and systems that fit different applications.

• According to the “House”, Stability and Standardization are the foundation. Just-in-Time and Jidoka are the pillars. Involvement is the Heart. All are focused on satisfying the customer with quality, cost and lead-time by continually eliminating waste from the processes.

• Several of the Lean ideas seem to be paradoxical in nature (pg 141) but if you approach the system with humility and open-mindedness you too can enjoy a Lean journey!

• Lean success requires a certain culture that not everyone is accustomed to or comfortable with. In Chapter 9, we see a summary of keys to this culture including:

1. Human Resources issues and questions.

2. Grasping the situation through PDCA.

3. The “Warm Heart” Principle – Hard on the problem, easy on the people.

4. Standardization, visual controls and Management as Theater.

5. Intensity.6. Respect for people.7. Continual improvement.

PDCA• GTS – grasping the situation, big picture, key parts, what is-

should happen, trends, value-goal-related.

– Plan – 5Ws + 1H, measurement plan, visual system– Do – contains its own PDCA cycle with pilot activities; assessment of

team capabilities, assess current condition.– Check – metrics to check outcome (final score) and process (along the

way). Go see what is happening.– Act – reflect on our condition, standardize when outcomes are on-

target, make countermeasures – when outcome or process results are substandard. (stop bleeding or root cause)

• A manager’s job is to practice and teach PDCA, do it in the day-to-day.

• Warm Heart Principle – Hard on problem, easy on people.

Standardization

• Standard – the best current method, but is meant to continually change.

• Standards make out-of-standard conditions obvious.

• A problem is a deviation from a standard (gap). Problem-solving funnel (p.151).

• Five Why’s (should get at root cause), which is usually: inadequate standards, inadequate adherence to standard, or inadequate system.

Visual Management

• Visual management triangle (p.31)• Management as theatre – make problems

visible – Line-side process reviews– Safety or quality “auctions” presentation

(attendees can ask questions, give advice, offer to help investigation)

– Current condition presentations– Hoshin (strategic) planning presentations

Teamwork

• Safety first – core value, like productivity & quality• Employment security – last choice• Uniforms – same regardless of position• No executive offices and no walls• No executive dining rooms or parking• Genchi genbutsu (Go see) – shop floor

Paradox

• Jidoka – Stop production so that production never has to stop.• Standards – change all the time.• One-at-a-time production – is more effective than batch

production.• Maximizing unit efficiencies – does not maximize overall

efficiency. • Don’t make something - unless a customer has ordered it.• Team members – not industrial engineers, develop

standardized work.• Seek perfection – even though we know we will never achieve

it. (humility)

Intensity & “do” of the Lean Culture

• Intensity (more and greater demands)– compels recognizing muda (waste) and kaizen (make small

improvements). – Recognize strain– Provide support and training – Maintain intensity of improvement

• The “do” concept is a “path” or a “way” – Humility – Lifelong learning– Respect for people

Exercise

• Give an example of where an organization, or you in your personal life utilize PDCA cycle.

• Include an example of where activities are adjusted using the “act” stage as a result of what was discovered during the “check” stage.

Quality Management Systems

Operation & control of process

Good design

Consistent method,

equipment, materials

Satisfactory instructions

Consistently Satisfied Customer

Voice of the customer (marketing activities)

Voice of the process(measurement activities)

Good Inputs - ingredients

How does Jamie make great food at all his restaurants?

Westland Place Old Street

20 New Change Passage

Upper St Martin's Covent Garden

Churchill Place, Canary Wharf

More than 17 around the London area

Quality Management System

• Jamie cannot run to each restaurant to make the food. • He can: ensure consistency of output by design/use of a

system, – make sure everyone uses it, – periodically check the people are operating according to the

system (system audit) and the food-system still meets the requirements (system review).

• A good QMS will meet: – the customer requirements – to deliver the desired product & – the organization requirements – efficient utilization of

resources (material, HR, technology, information).

QMS design

• Four main areas of process-based QMS– Management responsibility– Resource management– Product realization– Measurement, analysis and improvement

• ISO9001:2000 – QMS process model• ISO9000:2000 – family of standard

– Based on Eight principles: customer focus, leadership, involvement, process approach, system approach to management, continual improvement, factual approach, mutually beneficial supplier relationships.

QMS – continuous improvement

• One person alone cannot document a QMS: the task is the job of all who have responsibility for part of it.

• The quality system must be a practical working one – that way it ensures that consistency of operation is maintained and it may be used as a training aid.

• Operation of any process:– No process without data collection (measurement)– No data collection without analysis– No analysis without decisions– No decisions without actions (improvement)

• Good QMS: audit (check) & review (possible improvements) leads to -> corrective action

Management responsibilities - the first of four categories of the QMS

• Management Responsibilities– Focus on customer needs, – publish a quality policy, – top management commits, – written quality objectives– define who are responsible, – management review at intervals, – Quality manual (has a cycle of review)

• See example: http://kvalitet.himolde.no/

The other three categories of the QMS• Resource Management

– Human Resources – training (when, who)

• Product Realization - how processes influence/help meet product requirements– Customer related processes – customer specified, fitness-for-purpose, customer

requirements, legal requirements – Plan and control design and development of product. Concerned with stages, interfaces,

verification against input requirements, validation to needs of customer. – Validation can come from 3rd party reviews, modelling and simulation studies, pilot products

(sales and reviews). – Purchasing – supplier evaluations, supplier audits – Production and service delivery processes – suitable instructions, suitable installations,

monitoring, inspection, testing actives, etc. – Post-delivery services – monitor, calibrate, maintain, handle & store, measuring and

inspecting. Concerns with accuracy and precision.

• Measurement, analysis and improvement– Measuring and monitoring – internal audit (1.plan and schedule activities, 2. assign trained

independent of those being audited, 3. assure consistent basis for conducting audits is defined)

– Control of non-conforming products– Analysis of data– Improvement