When we talk with business owners about their company vision and values, we often hear them speak about quality. They say things like:
"We offer quality products"
"Quality is important to us"
When I ask them what they mean by the word "quality," they say quality means that they work the first time they're used. To others, quality refers to flawless workmanship in installation or using cost effective materials that stand up over time.
Reasonable companies don't set out to sell products that don't work, don't fit, or fall apart during the first year of (normal) use. Warranties are supposed to make us consumers feel assured that manufacturers stand behind their work.
So what does "quality" really mean? Quality can be defined as fitness for use, meeting customer satisfaction, and freedom from deficiencies (1).
Juran defines quality as satisfying customers through quality of design and quality of conformance (2).
Quality of design centers around meeting the changing needs of customers and markets. These include product features and options as well as service offerings. We know that consumer tastes change over time and demand can be fickle. Just look at the evolution of the cellular phone market. There was a time when we were just happy to have cordless mobile phones so we could make calls while on the go. Now we have features such as text messaging, calendars, ring-tone selections, speakerphones, cameras, and tip calculators that used to be options but are now capabilities included in about all cell phone offerings. More recent options include internet access, music downloads, and a myriad of applications. It's an ever-evolving list.
Quality of conformance requires a reduction in scrap, customer warranty claims and complaints, rework, repairs and other costs associated with failures. Freedom from deficiencies can result in significant reduction in costs. Cost reductions can mean more profit for the producer and/or lower sales prices for the customer.
Rework is expensive whether we're talking about re-machining a component that doesn't fit, troubleshooting a circuit that didn't work right, repairing broken web site links or fixing spelling errors in a marketing brochure that went to print. The service provider eats these costs and the customer is quite likely to become unhappy if there are on-going or recurring problems. Customers don't like to be the ones to find errors and problems in their purchases. And when there's a broad-scale manufacturer recall, everyone takes a hit in cost, convenience, and confidence: witness the auto industry and, by way of continuous "critical updates and service packs," the software industry.
On a personal note, my dishwasher has lasted for over 16 years. It's never been a problem appliance for me. Are there faster, quieter machines out there with more capacity? Sure. But I have no complaints for what I paid for it. On the other hand, the connector on my cell phone car charger cable broke apart after one year. Am I happy? No. Why should something that I don't use that often fall apart under normal use after one year? Whether this is a design or manufacturing defect or one of those "random, low-probability of occurrence" situations, I couldn't say. The phone seller replaced the charger cable at no charge to me, which is what I would have expected them to do but my impression of their charger quality is poor.
So in the end, quality is about what the customer wants and expects and how your business, as the product or service provider, delivers on that. I recall an old adage from my days as a design engineer - you can't inspect in quality, you need to design it in. In other words, you can't rely on inspections to catch failure-prone design problems. If your system for developing and delivering products or services is flawed, inspections or reviews won't catch every defect. In my opinion, your best bet is to have a solid, reliable way to ensure that you understand customer wants and expectations and be able to deliver on those. That's quality.
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Mar 31, 2010
Mar 28, 2010
Total Quality Management
TQM is a total quality management system. Based on practical experiences and people have a technique instructing how to improve the performance quality of the work.
According to ISO 9000, "Total Quality Management (TQM) is a management approach that aims for long-term success by focusing on customer satisfaction. TQM is based on the participation of all members of an organization in improving processes, products, services, and the culture in which they work."
According to Histoshi Kume, "TQM is a management method to success. It creates proper conditions for the sustainable development of the organization by directing all the employees' effort to create an economic quality pursuant to the customer's request".
The goal of TQM is to help producing a good quality product as well as lowing the cost, improving the productivity, shortening the delivery time. This also means that TQM aims for the 3P: (1) Performance (2) Price and (3) Punctuality of the quality of the product by the effort of all the member of the organization.
In general, TQM is a set of principles for improving the quality by encouraging all the direct and indirect employees in improving processes, products, services, and the culture.
These principles generally are:
1- It is the customers who set the quality standards for the product and their needs are absolute.
2- The highest level manager of the company must be the person who follows the quality standards.
3- Quality is a strategic matter and must be the priority to consider in plan making.
4- Quality is the problem of all the people of all levels and departments in the company and everyone must cooperate to solve this problem.
5- Functions of the company must focus on the Continuous Quality Improvement to reach the strategic goals of the company.
The problem solving and continuous quality improvement are based on the Statistic Quality Control method (SQC) and the use of the Deming Cycle.
The basic technique of TQM include:
o Quality control Circle
o 7 basic quality tools to control and improve the quality
o Kaizen (quality management theory by a Japanese)
o 5S (house keeping)
o QC story (Quality Control story) )
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According to ISO 9000, "Total Quality Management (TQM) is a management approach that aims for long-term success by focusing on customer satisfaction. TQM is based on the participation of all members of an organization in improving processes, products, services, and the culture in which they work."
According to Histoshi Kume, "TQM is a management method to success. It creates proper conditions for the sustainable development of the organization by directing all the employees' effort to create an economic quality pursuant to the customer's request".
The goal of TQM is to help producing a good quality product as well as lowing the cost, improving the productivity, shortening the delivery time. This also means that TQM aims for the 3P: (1) Performance (2) Price and (3) Punctuality of the quality of the product by the effort of all the member of the organization.
In general, TQM is a set of principles for improving the quality by encouraging all the direct and indirect employees in improving processes, products, services, and the culture.
These principles generally are:
1- It is the customers who set the quality standards for the product and their needs are absolute.
2- The highest level manager of the company must be the person who follows the quality standards.
3- Quality is a strategic matter and must be the priority to consider in plan making.
4- Quality is the problem of all the people of all levels and departments in the company and everyone must cooperate to solve this problem.
5- Functions of the company must focus on the Continuous Quality Improvement to reach the strategic goals of the company.
The problem solving and continuous quality improvement are based on the Statistic Quality Control method (SQC) and the use of the Deming Cycle.
The basic technique of TQM include:
o Quality control Circle
o 7 basic quality tools to control and improve the quality
o Kaizen (quality management theory by a Japanese)
o 5S (house keeping)
o QC story (Quality Control story) )
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Lean Manufacturing Tools
To build a lean manufacturing process you need alot of techniques and tools covering everything from quality control to the layout of facility.
The following tools and techniques form the focus of sound lean manufacturing process.
1- 5S – 5S is a lean manufacturing tool often used at the start of a lean manufacturing improvement process to optimise the workplace and ensure a safe working environment. Without 5S you can not build lean manufacturing.
2- Buffer and Safety Stock – Buffer stock is used to smooth out variations in the internal processes of the organization ensuring that these variations do not affect the customer. Safety stock is used to hedge against disruptions in the manufacturing process.
3- Cellular Layout – A tool used to maximize the efficiency, flexibility of the physical layout of each work station and minimize move distance.
4- Continuous Flow – Allows the movement of products through the value system without waste or inventory.
5- Cycle Time – A measurement of the time taken to complete a process and used to determine the number of operations required.
6- Heijunka – Also referred to as load levelling, a tool used to allow an organization to meet variations in the level of customer demand.
7- Just In Time (JIT) – An inventory strategy that reduces the need for in-process inventory.
8- Kaizen – A process of continuous improvement throughout business processes.
9- Kanban – A process of continuous supply of parts and supplies so that operatives have what they need when they need it.
10- Metrics – A way of measuring, evaluating, and responding to manufacturing performance without sacrificing quality or increasing inventory levels in an effort to achieve efficiencies in production.
11-Line Balancing/Level Load – The distribution of the work required to assemble a product across a set of work stations.
12- Mistake Proofing – Also referred to as Poka Yoke, involves simple methods for eliminating errors in business processes.
13- Quick Changeover – The ability to change tooling rapidly so that multiple products can be developed on a single machine.
14- Standard Work – A definition of the most efficient methods for producing a product using the available equipment, materials and people.
15- Takt Time – A measurement of the maximum time required to produce one unit of a product and often used as a target for the pace of production in lean manufacturing.
16- TPM - Total Productive Maintenance – A system of ensuring ‘zero-downtime’ of equipment, emphasising production operator involvement in equipment maintenance.
17- Value Stream Mapping – A lean technique used to track the flow of materials and/or information required to deliver a product to the end customer.
Waste – Defined as anything that does not add value to the process.
Needless to say, there are a wide variety of six sigma and lean tools and techniques available. This broad selection of improvement methods ensures that, whatever your business situation, there are options available to suit your needs and help you achieve your business improvement goals.
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The following tools and techniques form the focus of sound lean manufacturing process.
1- 5S – 5S is a lean manufacturing tool often used at the start of a lean manufacturing improvement process to optimise the workplace and ensure a safe working environment. Without 5S you can not build lean manufacturing.
2- Buffer and Safety Stock – Buffer stock is used to smooth out variations in the internal processes of the organization ensuring that these variations do not affect the customer. Safety stock is used to hedge against disruptions in the manufacturing process.
3- Cellular Layout – A tool used to maximize the efficiency, flexibility of the physical layout of each work station and minimize move distance.
4- Continuous Flow – Allows the movement of products through the value system without waste or inventory.
5- Cycle Time – A measurement of the time taken to complete a process and used to determine the number of operations required.
6- Heijunka – Also referred to as load levelling, a tool used to allow an organization to meet variations in the level of customer demand.
7- Just In Time (JIT) – An inventory strategy that reduces the need for in-process inventory.
8- Kaizen – A process of continuous improvement throughout business processes.
9- Kanban – A process of continuous supply of parts and supplies so that operatives have what they need when they need it.
10- Metrics – A way of measuring, evaluating, and responding to manufacturing performance without sacrificing quality or increasing inventory levels in an effort to achieve efficiencies in production.
11-Line Balancing/Level Load – The distribution of the work required to assemble a product across a set of work stations.
12- Mistake Proofing – Also referred to as Poka Yoke, involves simple methods for eliminating errors in business processes.
13- Quick Changeover – The ability to change tooling rapidly so that multiple products can be developed on a single machine.
14- Standard Work – A definition of the most efficient methods for producing a product using the available equipment, materials and people.
15- Takt Time – A measurement of the maximum time required to produce one unit of a product and often used as a target for the pace of production in lean manufacturing.
16- TPM - Total Productive Maintenance – A system of ensuring ‘zero-downtime’ of equipment, emphasising production operator involvement in equipment maintenance.
17- Value Stream Mapping – A lean technique used to track the flow of materials and/or information required to deliver a product to the end customer.
Waste – Defined as anything that does not add value to the process.
Needless to say, there are a wide variety of six sigma and lean tools and techniques available. This broad selection of improvement methods ensures that, whatever your business situation, there are options available to suit your needs and help you achieve your business improvement goals.
Great Directory
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Mar 26, 2010
What is Value Stream Mapping
Value stream mapping is often used at the outset of a lean program to identify the current process within an organization. Strictly speaking Value stream mapping is used to map information and materials through a production process – but it can be used for so much more than simply transcribing the process. So what are it’s benefits?
1/ It’s quick and easy to learn
2/ It helps portray the process from the start of the production process to the end
3/ It help finds bottlenecks
4/ It helps find waste within the process
5/ It’s a group excersise and therefore can involve your workforce as part of your lean improvement program
6/ You can use a completed value stream map as an improvement aide to document transitions to a future state value stream map
7/ Its an inexpensive tool – all you need is a paper and pen!
8/ It can be easily critiqued by your workforce (using post it notes) to highlight problems that exist within the process
9/ It’s not just for manufacturing! Value stream mapping has been used in offices, service industries healthcare etc.
10/ It’s easy to understand – With a little bit of training on VSM icons – maps are easy to understand conveying powerfull process in a simple pictorial fashion.
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1/ It’s quick and easy to learn
2/ It helps portray the process from the start of the production process to the end
3/ It help finds bottlenecks
4/ It helps find waste within the process
5/ It’s a group excersise and therefore can involve your workforce as part of your lean improvement program
6/ You can use a completed value stream map as an improvement aide to document transitions to a future state value stream map
7/ Its an inexpensive tool – all you need is a paper and pen!
8/ It can be easily critiqued by your workforce (using post it notes) to highlight problems that exist within the process
9/ It’s not just for manufacturing! Value stream mapping has been used in offices, service industries healthcare etc.
10/ It’s easy to understand – With a little bit of training on VSM icons – maps are easy to understand conveying powerfull process in a simple pictorial fashion.
SearchWIZ
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Total Quality Management Characteristics
TQM is a method of quality management involving many levels of different functions, but requiring an integrated cooperation. Characteristics of TQM can be listed as follows:
1. Target:
In TQM, the most important target to achieve is Quality; Quality policy must be set toward customer. Meeting customer's requirements but not trying to reach some quality standards set before. Never stop innovating - never stop perfecting the quality is one of the most important principles of TQM.
2. Scope:
To ensure the quality of service and product, TQM system requires the extending of production process to suppliers and sub-contractors. Normally, the trading of material in production may account for 70% of final product cost (depend on types of product). Therefore, to ensure the quality of the input material, it is necessary to set up specific standards for each type of material to control its quality. It is also necessary to change the method of placing order to make it suitable with the production process.
3. Form:
In stead of controlling the quality of the finished product (after production), TQM sets up plans and programs to supervise and prevent problems right before the production process. Statistical tools are used to supervise, quantitatively analyze the results as well as factors affecting the quality, consider the reasons and take appropriate prevention methods.
4. Basis of TQM system:
The basis of TQM practice in the company is Human. Talking about quality, people usually think about the product quality. But it is the quality of employees that is the main concern of TQM. Of the three factors of Business, which are hard factor (machines, equipments, money...), Soft factor (methods, secrets, information...) and Human factor, Human is of the first concern to TQM.
The basic principle for implementation of TQM is that the qualification of employees is developed fully and integratedly through training, delegation and assignment.
5. Organization:
TQM system is cross organized and functioned in order to manage, integratedly corporate with different activities of the system and facilitate group working. The implementation of TQM requires the participation of high and middle level managers. A proper organization will help duties to be assigned clearly. Thus, TQM needs new management model, with different characteristics from the previous model.
6. Management skills and tools:
Methods to implement must be based on the principle "do correctly at the very beginning", in researching and designing to minimize economic cost. Strictly apply DEMMING circle (PDCA) to make foundation for the continuous quality improvement.
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1. Target:
In TQM, the most important target to achieve is Quality; Quality policy must be set toward customer. Meeting customer's requirements but not trying to reach some quality standards set before. Never stop innovating - never stop perfecting the quality is one of the most important principles of TQM.
2. Scope:
To ensure the quality of service and product, TQM system requires the extending of production process to suppliers and sub-contractors. Normally, the trading of material in production may account for 70% of final product cost (depend on types of product). Therefore, to ensure the quality of the input material, it is necessary to set up specific standards for each type of material to control its quality. It is also necessary to change the method of placing order to make it suitable with the production process.
3. Form:
In stead of controlling the quality of the finished product (after production), TQM sets up plans and programs to supervise and prevent problems right before the production process. Statistical tools are used to supervise, quantitatively analyze the results as well as factors affecting the quality, consider the reasons and take appropriate prevention methods.
4. Basis of TQM system:
The basis of TQM practice in the company is Human. Talking about quality, people usually think about the product quality. But it is the quality of employees that is the main concern of TQM. Of the three factors of Business, which are hard factor (machines, equipments, money...), Soft factor (methods, secrets, information...) and Human factor, Human is of the first concern to TQM.
The basic principle for implementation of TQM is that the qualification of employees is developed fully and integratedly through training, delegation and assignment.
5. Organization:
TQM system is cross organized and functioned in order to manage, integratedly corporate with different activities of the system and facilitate group working. The implementation of TQM requires the participation of high and middle level managers. A proper organization will help duties to be assigned clearly. Thus, TQM needs new management model, with different characteristics from the previous model.
6. Management skills and tools:
Methods to implement must be based on the principle "do correctly at the very beginning", in researching and designing to minimize economic cost. Strictly apply DEMMING circle (PDCA) to make foundation for the continuous quality improvement.
1Abc Directory
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Mar 25, 2010
Comparison Between ISO 9001-2008 Vs ISO 9001-2000
ISO 9001: 2008 is really an exciting moment for quality managers. In order to celebrate this event in a way that only quality managers know how, I prepared here a comparison between the ISO 9001:2000 and the ISO 9001:2008.
Paragraph number 0.1 - Changes here are a statement about whom and where the standard includes any statutory requirements. Statutory requirement (of any kind) has the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product.
Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.
There is a big correlation between the ISO 14001:2004 & ISO 9001. They actually support one another. It would be easier for organization to obtain the ISO standard 14001 requirements if it has been already certified for ISO 9001.
Paragraph number 1.1 & 1.2 - Statutory requirements had been referred in relation with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.
My comment - After so many years of auditions the long last debate had been settled. Statutory legal requirements and regulatory requirements are applicable to the purchasing processes as well. It was always an open area that no one had the exact answer: Does your supplier must follow the law or not? Apparently yes.
Paragraph number 2 - Normative reference - the ISO 9000 is now replaced by ISO 9000:2005.
Paragraph number 3 - The explanations about what is a customer and what is an organization and what is a supplier had been removed.
Paragraph number 4.1 - Clause a - The word "determine" replaces the word "identify". A note had been added stating that a purchased processes are regarded as purchasing products. Another note had been added demanding that these processes would be controlled as well as products.
My comment - When identifying, you are required to search and find something according to the requirement. When determining, the responsibility of the results is in your hands...
It was obvious before.... Sometime they feel a need to state the obvious.
Paragraph number 4.2.1 - Slight change of words, but when you examine the change you realize the meaning remains same.
Note 2 was changed: A single document may include requirements for more than one procedure. Requirements of one procedure may appear in more than one document.
My comment - It's about time. A lot of headaches are vowed to be save. If your auditor was one of the old schools and demanded everything by the book, you had troubles. Now you may document two quality requirements on one document: Job description and trainings, for example. Or you can split one record into two documents. However it is suitable for you as long as you achieve the requirements.
A good example is that it is possible to combine the corrective and the preventive procedures together. As long as you maintain the requirements...
Paragraph number 4.2.3 - Paragraph f - A clarification that external documentation is considered while it is part of the quality management system.
My comment - When an external document is part of your quality management system, it is required to be included under the quality procedures: documents control and records control.
Paragraph number 5.1 - Clause a - the word "statutory" had been added.
Paragraph number 5.5.2 - An additional requirement that the management representative would be a member of the organization's management.
My comment - That addition puts all external consultants at risk - you can no longer be the management representative. That sets a whole new line of form and documentations for you to develop in order that the external consultants would be considered as a management representative. All external consultants would have to be creative on this one.
Paragraph number 6.2 - Change of words from "affecting product quality" to "affecting conformity to product requirements"
Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the necessary competence"
Clause c - you must ensure that the training is with competence rather than if it was an effective training.
My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new. On one hand it is an improvement. The training must be reviewed before for its competence to the requirements. But we are still on this one. We think: instead of testing your employees if they got anything out of the training you must now review the training itself before or maybe both.... Only time will tell...
Paragraph number 6.3 - Clause c - information systems are included.
My comment - They are totally right!
Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environment.
My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine the OHSAS 18001 Standard...
Paragraph number 7.1 - Clause c - measurement had been added to the product acceptance activities.
Paragraph number 7.2.1 - Clause a - change of words - not of the meaning.
Clause c - the word 'applicable' replaces 'related'. Change of words - not of the meaning.
Clause d - change of words - not of meaning.
A note had been added to explain the meaning of "post delivery activities".
My comment - I agree with the "post delivery activities" - it wasn't clear enough for our opinion.
Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together.
Paragraph number 7.3.3 - A change of words. A note had been added clarifying the inclusion of "preservation of product".
My comment - The preservation of the product is to be included now in the design and the development outputs.
Paragraph number 7.5.3 - A requirement had been added regarding the measurements and test status must be identified throughout the product realization.
My comment - This requirement so far was required in standards such as ISO 13485 Standard for medical devices and the ISO/TS 16949 for the automobile industry. The requirement assures you that the inspection activities are defined maintained and recorded and so is the product's status.
Paragraph number 7.5.4 - A change of words in the requirement to inform the customer of any problem regarding his property.
The note had been amended that also personal data is included as customer's property.
Paragraph number 7.5.5 - A change of words:
"devices" in the title was changed to "equipment"
"conformity of" to "in order to maintain conformity to requirements".
Reference to paragraph 7.1 was removed
Paragraph number 7.6 - A change of words:
from "devices" to "equipment".
The reference to paragraph 7.2.1 had been removed.
Clause c - from "be identified to enable the"
to" identification to enable their".
Changes in the notes:
Note 1 - the reference to ISO 100012-2 had been removed.
Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.
My comment - That means that from now on, a computers that provides any kind of measurements services, is considered as a monitoring and measuring device. And when the computer configuration has been changed - the software is required to be calibrated again.
How can one calibrate a computer? Ask your supplier or your system administrator. They will know better than anyone. But you would have to prove it has been done and present evidences.
Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation.
Paragraph number 8.2.2- Requirements for the audit evidence and results had been added.
Requirements for the management responsibility had been added - The management is responsible for ensuring preventive and corrective action to be taken.
The reference to the ISO 10011 is changed to ISO 19011.
My comment - As I see it, that means an addition within the Management Responsibility procedure or the Internal audit procedure about management ensuring that preventive and corrective actions would be taken according to the results and decisions of the internal audit and a reference to the validation and verification.
Take a look at the next web site that provides you with prepared solutions for internal audit procedure the9000store.com.
Paragraph number 8.2.3 - A change of words:
"to ensure conformity of the product" had been removed.
A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement.
Paragraph number 8.3 - An addition: Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.
So, what are the new requirements of the new standard?
Statutory requirements are given scale as any other legal or customer's requirements.
The statutory requirements include the suppliers as well.
A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality management system.
You may include two quality processes in one document and split one process into two documents.
The management representative must be a member of the top management.
A requirement to ensure that trainings are suitable for the product in advance and not to examine whether the training was effective after it was taken.
Information system is now officially considered as a substructure.
Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
Measuring is considered as one of the activities of product realization. The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes.
The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes.
Software configuration is a reason for re-calibrating the software.
The management is now responsible for preventive and corrective actions regarding nonconformities that were revealed during internal audits.
The organization should determine the type of the monitoring and measuring according to the processes and indicate how this would affect the quality management system.
Summary
Most of the changes made here are really minor and are assistance for understanding open issues. I excepted a bit more of new standard but I am satisfied. The objective was not to create any earth qaukes in the quality industry but to keep update with changes in technology and to update the feedbacks and responses that were gathered over the last years. I am lucky . I already thought that all my articles in our website should be changed...
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Paragraph number 0.1 - Changes here are a statement about whom and where the standard includes any statutory requirements. Statutory requirement (of any kind) has the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product.
Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.
There is a big correlation between the ISO 14001:2004 & ISO 9001. They actually support one another. It would be easier for organization to obtain the ISO standard 14001 requirements if it has been already certified for ISO 9001.
Paragraph number 1.1 & 1.2 - Statutory requirements had been referred in relation with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.
My comment - After so many years of auditions the long last debate had been settled. Statutory legal requirements and regulatory requirements are applicable to the purchasing processes as well. It was always an open area that no one had the exact answer: Does your supplier must follow the law or not? Apparently yes.
Paragraph number 2 - Normative reference - the ISO 9000 is now replaced by ISO 9000:2005.
Paragraph number 3 - The explanations about what is a customer and what is an organization and what is a supplier had been removed.
Paragraph number 4.1 - Clause a - The word "determine" replaces the word "identify". A note had been added stating that a purchased processes are regarded as purchasing products. Another note had been added demanding that these processes would be controlled as well as products.
My comment - When identifying, you are required to search and find something according to the requirement. When determining, the responsibility of the results is in your hands...
It was obvious before.... Sometime they feel a need to state the obvious.
Paragraph number 4.2.1 - Slight change of words, but when you examine the change you realize the meaning remains same.
Note 2 was changed: A single document may include requirements for more than one procedure. Requirements of one procedure may appear in more than one document.
My comment - It's about time. A lot of headaches are vowed to be save. If your auditor was one of the old schools and demanded everything by the book, you had troubles. Now you may document two quality requirements on one document: Job description and trainings, for example. Or you can split one record into two documents. However it is suitable for you as long as you achieve the requirements.
A good example is that it is possible to combine the corrective and the preventive procedures together. As long as you maintain the requirements...
Paragraph number 4.2.3 - Paragraph f - A clarification that external documentation is considered while it is part of the quality management system.
My comment - When an external document is part of your quality management system, it is required to be included under the quality procedures: documents control and records control.
Paragraph number 5.1 - Clause a - the word "statutory" had been added.
Paragraph number 5.5.2 - An additional requirement that the management representative would be a member of the organization's management.
My comment - That addition puts all external consultants at risk - you can no longer be the management representative. That sets a whole new line of form and documentations for you to develop in order that the external consultants would be considered as a management representative. All external consultants would have to be creative on this one.
Paragraph number 6.2 - Change of words from "affecting product quality" to "affecting conformity to product requirements"
Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the necessary competence"
Clause c - you must ensure that the training is with competence rather than if it was an effective training.
My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new. On one hand it is an improvement. The training must be reviewed before for its competence to the requirements. But we are still on this one. We think: instead of testing your employees if they got anything out of the training you must now review the training itself before or maybe both.... Only time will tell...
Paragraph number 6.3 - Clause c - information systems are included.
My comment - They are totally right!
Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environment.
My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine the OHSAS 18001 Standard...
Paragraph number 7.1 - Clause c - measurement had been added to the product acceptance activities.
Paragraph number 7.2.1 - Clause a - change of words - not of the meaning.
Clause c - the word 'applicable' replaces 'related'. Change of words - not of the meaning.
Clause d - change of words - not of meaning.
A note had been added to explain the meaning of "post delivery activities".
My comment - I agree with the "post delivery activities" - it wasn't clear enough for our opinion.
Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together.
Paragraph number 7.3.3 - A change of words. A note had been added clarifying the inclusion of "preservation of product".
My comment - The preservation of the product is to be included now in the design and the development outputs.
Paragraph number 7.5.3 - A requirement had been added regarding the measurements and test status must be identified throughout the product realization.
My comment - This requirement so far was required in standards such as ISO 13485 Standard for medical devices and the ISO/TS 16949 for the automobile industry. The requirement assures you that the inspection activities are defined maintained and recorded and so is the product's status.
Paragraph number 7.5.4 - A change of words in the requirement to inform the customer of any problem regarding his property.
The note had been amended that also personal data is included as customer's property.
Paragraph number 7.5.5 - A change of words:
"devices" in the title was changed to "equipment"
"conformity of" to "in order to maintain conformity to requirements".
Reference to paragraph 7.1 was removed
Paragraph number 7.6 - A change of words:
from "devices" to "equipment".
The reference to paragraph 7.2.1 had been removed.
Clause c - from "be identified to enable the"
to" identification to enable their".
Changes in the notes:
Note 1 - the reference to ISO 100012-2 had been removed.
Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.
My comment - That means that from now on, a computers that provides any kind of measurements services, is considered as a monitoring and measuring device. And when the computer configuration has been changed - the software is required to be calibrated again.
How can one calibrate a computer? Ask your supplier or your system administrator. They will know better than anyone. But you would have to prove it has been done and present evidences.
Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation.
Paragraph number 8.2.2- Requirements for the audit evidence and results had been added.
Requirements for the management responsibility had been added - The management is responsible for ensuring preventive and corrective action to be taken.
The reference to the ISO 10011 is changed to ISO 19011.
My comment - As I see it, that means an addition within the Management Responsibility procedure or the Internal audit procedure about management ensuring that preventive and corrective actions would be taken according to the results and decisions of the internal audit and a reference to the validation and verification.
Take a look at the next web site that provides you with prepared solutions for internal audit procedure the9000store.com.
Paragraph number 8.2.3 - A change of words:
"to ensure conformity of the product" had been removed.
A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement.
Paragraph number 8.3 - An addition: Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.
So, what are the new requirements of the new standard?
Statutory requirements are given scale as any other legal or customer's requirements.
The statutory requirements include the suppliers as well.
A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality management system.
You may include two quality processes in one document and split one process into two documents.
The management representative must be a member of the top management.
A requirement to ensure that trainings are suitable for the product in advance and not to examine whether the training was effective after it was taken.
Information system is now officially considered as a substructure.
Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
Measuring is considered as one of the activities of product realization. The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes.
The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes.
Software configuration is a reason for re-calibrating the software.
The management is now responsible for preventive and corrective actions regarding nonconformities that were revealed during internal audits.
The organization should determine the type of the monitoring and measuring according to the processes and indicate how this would affect the quality management system.
Summary
Most of the changes made here are really minor and are assistance for understanding open issues. I excepted a bit more of new standard but I am satisfied. The objective was not to create any earth qaukes in the quality industry but to keep update with changes in technology and to update the feedbacks and responses that were gathered over the last years. I am lucky . I already thought that all my articles in our website should be changed...
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Mar 23, 2010
an ISO 9001 Quality Management System
ISO 9001 certification will almost certainly enhance an organization's reputation. The ISO 9001 standard requires the implementation of a documented quality management system to facilitate enhanced performance and efficiency.
ISO 9001 certification is intended for any organization regardless of size, type or product including service. According to the ISO 9001 standard there are a number of system requirements which an organization needs to fulfill in order meet customer requirements. Ensuring customer satisfaction through the quality management system is a key aim of the standard. The ISO 9001 standard also includes elements that require monitoring and measurement of processes and continual improvement.
In order to achieve certification an organization should have a documented quality management system and not a system of documents. The three main objectives of the documentation should be for communication of information, evidence of conformity and knowledge sharing. Quality management system documentation may be in any form or type of medium such as paper, electronic or picture. A compliant quality management system will need to address key elements of the standard. There are five sections that outline the requirements of a compliant system, section 4 Quality Management System, section 5 Management Responsibility, section 6 Resource Management, section 7 Product Realisation and section 8 Measurement Analysis.
ISO 9001 section 4 requires that an organization has a documented system with procedures in place to control documents and records. Section 5 requires the quality management system to include a quality policy and for senior management to demonstrate management commitment, allocate responsibility and authority, and conduct management reviews
Section 6 of the standard requires your system to address and review requirements for resources, human resources and training, infrastructure and work environment. Section 7 of the standard defines the requirements for planning, design and development, purchasing, production, control of customer property and monitoring and measurement. Section 8 defines the quality management system requirements for measurement, monitoring and improvement and includes sub-clauses internal audit, control of non-conforming product, corrective action and preventative action, all of which are compulsory procedures as defined by the standard.
ISO 9001:2008 refers specifically to only 6 documented procedures, however, other documentation may be required by an organization in order to manage the processes that are necessary for the effective operation of the QMS. In addition to the minimum document requirements the standard defines twenty one specific requirements for records.
The documentation required in a system to achieve ISO 9001 certification is no longer as onerous as prior to 2000 and the value of ISO 9001 certification for an organisation has never been higher. Certification sends a clear message to all interested parties that an organization is committed to high standards and continual improvement.
http://www.fasthits.info/?ref=15000
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ISO 9001 certification is intended for any organization regardless of size, type or product including service. According to the ISO 9001 standard there are a number of system requirements which an organization needs to fulfill in order meet customer requirements. Ensuring customer satisfaction through the quality management system is a key aim of the standard. The ISO 9001 standard also includes elements that require monitoring and measurement of processes and continual improvement.
In order to achieve certification an organization should have a documented quality management system and not a system of documents. The three main objectives of the documentation should be for communication of information, evidence of conformity and knowledge sharing. Quality management system documentation may be in any form or type of medium such as paper, electronic or picture. A compliant quality management system will need to address key elements of the standard. There are five sections that outline the requirements of a compliant system, section 4 Quality Management System, section 5 Management Responsibility, section 6 Resource Management, section 7 Product Realisation and section 8 Measurement Analysis.
ISO 9001 section 4 requires that an organization has a documented system with procedures in place to control documents and records. Section 5 requires the quality management system to include a quality policy and for senior management to demonstrate management commitment, allocate responsibility and authority, and conduct management reviews
Section 6 of the standard requires your system to address and review requirements for resources, human resources and training, infrastructure and work environment. Section 7 of the standard defines the requirements for planning, design and development, purchasing, production, control of customer property and monitoring and measurement. Section 8 defines the quality management system requirements for measurement, monitoring and improvement and includes sub-clauses internal audit, control of non-conforming product, corrective action and preventative action, all of which are compulsory procedures as defined by the standard.
ISO 9001:2008 refers specifically to only 6 documented procedures, however, other documentation may be required by an organization in order to manage the processes that are necessary for the effective operation of the QMS. In addition to the minimum document requirements the standard defines twenty one specific requirements for records.
The documentation required in a system to achieve ISO 9001 certification is no longer as onerous as prior to 2000 and the value of ISO 9001 certification for an organisation has never been higher. Certification sends a clear message to all interested parties that an organization is committed to high standards and continual improvement.
http://www.fasthits.info/?ref=15000
The Most Popular Website Directory
read more »
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