Quality Management: understanding Quality Management

Quality Management may be defined as the process through which organizations apply statistical process control mechanisms in order to improve the quality and standards of goods and services that are manufactured. Closely related to Quality Management is tqm, also known as total quality management. This is basically a management strategy that is applied in businesses in order to create awareness of high quality in most organizational processes. Quality Management features three main components including quality assurance, quality improvement and quality control. Quality management is focused not only on the quality of products and services but also on continuous improvement of quality standards.

Most methods that are now being used for Quality Management, quality system and quality manufacturing system take into consideration the need for high quality as an essential attribute in services and products that are manufactured by companies and organizations. Quality Management usually involves the successful improvement of quality of services and products. This is usually done through quality training processes where one can also acquire lessons on quality process and process management. One tool that is used for ensuring auditing quality in Quality Management is the MasterControlQAAD(TM) software. Besides using tools to carry out Quality Management successfully, one can also consider applying project management. This will help ensure continuous quality improvement.

The other way through which organizations can improve quality of process and service output is by using six sigma. This is basically a business management strategy that helps identify and remove defects and variations in the manufacturing process. It also helps guarantee Quality Management. It works by using a set of high quality business management and overall management methods to ensure quality and guarantee Quality Management. Most products and services to which Quality Management is applied are certified with iso certificates. Some of the iso certificates that guarantee that a product or service has undertaken Quality Management, change management and process improvement is iso 9001.

iso 9001 and iso 14001:2004 set down specific guidelines for environmental management systems and Quality Management. Other guidelines can be found in other generic process management philosophies such as the lean management that follows iso 9000 quality improvement standards aimed at guaranteeing total quality to its quality systems. The other mode through which organizations guarantee Quality Management is by use of a quality plan that meets iso 14000 and iso 14001 iso certification requirements. The other iso certification that guarantees product quality in Quality Management include iso 9001 2000.

In order to meet supplier quality in Quality Management systems, there are several iso training sessions that are offered. These meet iso standards. An organization that is in need of Quality Management for its products and services may also consider using a quality manual for its day to day Quality Management plans. Such a manual will usually have guidelines for iso quality. However, when applying the guidelines in the manual, regard must be had to quality audit measures aimed at guaranteeing Quality Management for the organization. Quality Management also involves knowledge of as9100 and iso 13485 that are commonly applicable in supplier management.

Quality Management programs that are iso certified help offer quality policy to existing iso 9001 certifications and quality management system that meet iso 9000 and ts16949 requirements. Quality companies that are aimed at ensuring Quality Management for the products and services that they manufacture also use quality management software that guarantees managing quality. In order to enhance Quality Management, the software guarantees quality procedures through its high rate of functionality. Besides such software, an organization can adopt quality assurance training and also offer quality consulting to its members in order to guarantee Quality Management to its products and services.

There are also several quality project management plans, which meet iso standards such as iso 9002 that are available today. Such plans are usually developed with a view to developing flexible, affordable and scalable management solutions to companies that seek to uphold Quality Management for their products and services. Such plans feature quality management systems that offer quality control management and quality assurance management through quality a management plan. Other quality objectives that can be obtained through iso 9001 training thus meeting iso 9000 certification use project management skills to improve Quality Management for the manufactured products and services.

ISO 9001:2008 Requirements – Resource Management

ISO 9001:2008 Requirements – Resource Management

6.1 Provision of Resources
Determine and provide the resources necessary to:
? Implement and maintain the quality management system
? Continually improve the effectiveness of the system
? Enhance customer satisfaction by meeting customer requirements
6.2 Human Resources
6.2.1 General
Ensure people performing work affecting conformity to product requirements are competent based on the appropriate education, training, skills, and experience.
NOTE: Conformity to product requirements can be affected directly, or indirectly, by personnel performing any task within the quality management system.
6.2.2 Competence, Training, and Awareness
The organization must:
? Determine the competency needs for personnel
? Provide training (or take other actions) to achieve the necessary competence
? Evaluate the effectiveness of the actions taken
? Inform employees of the relevance and importance of their activities
? Ensure they know their contribution to achieving quality objectives
? Maintain education, training, skill, and experience records

6.3 Infrastructure
Determine, provide, and maintain the necessary infrastructure to achieve product conformity. Infrastructure includes, as applicable:
? Buildings, workspace, and associated utilities
? Process equipment (both hardware and software)
? Supporting services (such as transport, communication, or information systems)
6.4 Work Environment
Determine and manage the work environment needed to achieve product conformity.
NOTE: The term “work environment” relates to those conditions under which work is performed, including physical, environmental, and other factors such as noise, temperature, humidity, lighting, or weather.

Validity of certifications to ISO 9001:2000

One year after the publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008.
Twenty four months after publication by ISO of ISO 9001:2008, any existing
certification issued to ISO 9001:2000 shall not be valid.

Organisations that are already certified to ISO 9001:2000 should contact
their certification/registration bodies (CB/RB) to agree a programme for analysing the clarifications in ISO 9001:2008 in relation to their individual quality management systems and for upgrading their certificates.
Certified organizations should bear in mind that ISO 9001:2000 certificates
have the same status as new ISO 9001:2008 certificates during the co-existence period. (i.e. Your current ISO 9001:2000 certificate will be valid up to 13th November 2010).
Organizations in the process of certification to ISO 9001:2000 should change to using ISO 9001:2008 and apply for certification to it.
New users should start by using ISO 9001:2008.

ISO 9000 Standards – Design and development

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

What is ISO 9000 Standards?

What is ISO 9000 Standards?

Preparing ISO 9000 Standards Quality Manual

Preparing ISO 9000 Standards Quality Manual

ISO 9000 Standards – Retention Of Records

ISO 9000 Standards – Retention Of Records
It is important that records are not destroyed before their useful life is over.
There are several factors to consider when determining the retention time for records.
The duration of the contract – some records are only of value whilst the contract is in force.
The life of the product – access to the records will probably not be needed for some considerable time, possibly long after the contract has closed. On defence contracts the contractor has to keep records for up to 20 years and
for product liability purposes, in the worst-case situation (taking account of
appeals) you could be asked to produce records up to 17 years after you made the product.
The period between management system assessments – assessors may wish to see evidence that corrective actions from the last assessment were taken. If the period of assessment is three years and you dispose of the evidence after 2 years, you will have some difficulty in convincing the assessor that you corrected the deficiency.
You will also need to take account of the subcontractor records and ensure
adequate retention times are invoked in the contract.
Where the retention time is actually specified can present a problem. If you
specify it in a general procedure you are likely to want to prescribe a single
figure, say 5 years for all records. However, this may cause storage problems – it may be more appropriate therefore to specify the retention times in the procedures that describe the records. In this way you can be selective.
You will also need a means of determining when the retention time has
expired so that if necessary you can dispose of the records. The retention time doesn’t mean that you must dispose of them when the time expires – only that you must retain the records for at least that stated period. Not only will the records need to be dated but the files that contain the records need to be dated and if stored in an archive, the shelves or drawers also dated. It is for this reason that all documents should carry a date of origin and this requirement needs to be specified in the procedures that describe the records. If you can rely on the selection process a simple method is to store the records in bins or computer disks that carry the date of disposal.
While the ISO 9000 requirement applies only to records, you may also need to retain tools, jigs, fixtures, test software – in fact anything that is needed to repair or reproduce equipment in order to honour your long-term commitments.
Should the customer specify a retention period greater than what you
prescribe in your procedures, special provisions will need to be made and this is a potential area of risk. Customers may choose not to specify a particular time and require you to seek approval before destruction. Any contract that requires you to do something different creates a problem in conveying the requirements to those who are to implement them. The simple solution is to persuade your customer to accept your policy. You may not want to change your procedures for one contract. If you can’t change the contract, the only alternative is to issue special instructions. You may be better off storing the records in a special contract store away from the normal store or alternatively attach special labels to the files to alert the people looking after the archives.