IATF 16949:2016 Clause 4.4.1.1 Conformance of products and processes

Conformance of products and processes is the ability of a product, service, or process to meet its design specifications. Design specifications are an interpretation of what the customer needs. Of course, a product having a high quality of conformance may still not be perceived by a customer as being an acceptable product if the person who created the design specifications did not correctly interpret what the customer wanted. Conformance is measured within an acceptable tolerance range. For example, if customers expect delivery of a car within 10 minutes of its scheduled delivery date, then any delivery time within that time frame has a high quality of conformance, while any longer interval does not. Thus, it equates to conformance to specifications within an acceptable tolerance range.

It is possible for a product to be of extremely high quality in terms of being produced within a tight tolerance range, using premium materials, and including all possible features. However, if the design specifications call for a less expensive product with fewer features, then the product is considered to have a low quality of conformance. This means that a high cost does not necessarily equate to a high quality of conformance. As an example, if a car is designed to sell at a low price, have excellent fuel economy, and operate reliably, then those are the key specifications that the actual vehicle must meet in order to have a high quality of conformance. If the vehicle were to have an oversized engine that provided more torque than necessary, it would have a low quality of conformance, because including such an engine would increase the price of the car and result in a lower fuel economy. A management technique is to track how persistently a product or service is measured close to the outer boundary established for conformance. If the measurement remains near the boundary for a significant period of time, it is likely that a breach of the measurement threshold will occur soon, so management can begin to direct attention to rectifying the issue. For example, a delivery that is consistently within just a few moments of the maximum allowable delivery threshold should be investigated. Such investigations may locate problems that can be rectified, or perhaps detect intentional measurement errors to keep the reported amounts within the conformance threshold.

Before we discuss on Conformance of products and processes, we must discuss three aspects associated with definition of quality: quality of design, quality of conformance. and quality of performance.

1. Quality of Design
   Quality is all about set conditions that the product or service must minimally have to satisfy the requirements of the customer. Thus. the product or service must be designed in such a way so as to meet at least minimally the needs of the consumer. However. the design must be simple and also less expensive so as to meet the customers‘ product or service expectations. Quality of design is influenced by many factors. such as product type, cost, profit, policy, the demand of the availability of parts and materials, and product reliability.
2. Quality of Conformance
   Quality of conformance is basically the standards defined in the design phase after the product is manufactured or while the service is delivered. This phase is also concerned about is control starting from raw material to the finished product. Three broad aspects are covered in this definition. viz. defect detection, defect root cause analysis. and defect prevention. Defect prevention deals with the means to deter the occurrence of defects and is usually achieved using statistical process control techniques defects maybe by inspection. testing or statistical data analysis collected fiom process, the root causes behind the presence of defects are investigated. and finally corrective actions are taken to prevent the recurrence of the defect.
3. Quality of Performance
   Quality of performance is how well the product functions or service performs when put to use. It measures the degree to which the product or Service satisfies the customer from the perspective of both design and the quality of conformance. Meeting customer expectations is the focus when we talk about performance. Automobile industry conduct test drive of vehicles to collect information about mileage, oil consumption. Bulbs are life tested to understand their reliability during useful life. The customer survey is conducted to find customer‘s perception about service delivered. If the product or service does not live up to customer expectations then adjustments are needed in the design or conformance phase.

IATF 16949:2016 Clause 4.4.1.1 Conformance of products and processes

The organization has to  ensure conformance of all its products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements

Explanation:

All customers have needs, requirements, wants, and expectations. Needs are essential to maintain certain standards, or essential for products and services, to fulfill the purpose for which they have been acquired. Requirements are what is requested of others and may encompass needs but often are not realized until after we have been made.  Hence requirements at the moment of sale may or may not express all needs. Requirements may include wants — nice to have but not essential. Expectations are implied needs or requirements. They have not been requested because it is taken for granted — regarded as to be understood as the accepted norm. They may be things to which customers are accustomed, based on fashion, style, trends, or previous experience. In supplying products or services there are three fundamental parameters that determine their saleability. They are price, quality, and delivery. Customers require products and services of a given quality to be delivered by or be available by a given time and to be of a price that reflects value for money. If you want to know who does the best-unemployed loans able to offer you a good service, check outwww.pickaloan.co.uk for more details. These are the requirements of customers. An organization will survive only if it creates and retains satisfied customers and this will only be achieved if it offers for sale products or services that respond to customer needs and expectations as well as requirements. While the price is a function of cost, profit margin, and market forces, and delivery is a function of the organization’s efficiency and effectiveness, quality is determined by the extent to which a product or service successfully serves the purposes of the user during usage (not just at the point of sale). Price and delivery are both transient features, whereas the impact of quality is sustained long after the attraction or the pain of price and delivery have subsided. A product that possesses features that satisfy customer needs is a quality product. Likewise, one that possesses features that dissatisfy customers is not a quality product. The customer is the only one who can decide whether the quality of the products and services you supply is satisfactory and you will be conscious of this either by direct feedback or by loss of sales, reduction in market share, and, ultimately, loss of business.

Quality characteristics

Any feature or characteristic of a product or service which is needed to satisfy customer needs or achieve fitness for use is a quality characteristic. When dealing with products the characteristics are almost always technical characteristics, whereas service quality characteristics have a human dimension. Some typical quality characteristics are given in the table below.

These are the characteristics that need to be specified and their achievement controlled, assured, improved, managed, and demonstrated. When the value of these characteristics is quantified or qualified they are termed quality requirements or requirements for quality. Requirements for quality can be defined as an expression of the needs or their translation into a set of quantitatively or qualitatively slated requirements for the characteristics of an entity to enable its realization and examination.  Technical requirements for a product or service are quality requirements. In practice, characteristics are usually classified into the categories critical, major, and minor. The terms can be defined in simple terms as follows:

1. Critical characteristic—Any feature whose Failure can reasonably be expected to present a safety hazard either to the user of the product or to anyone depending on the product functioning properly.
2. Major characteristic—Any Feature, other than critical. whose failure would likely result in a reduction of the usability of the product.
3. Minor characteristic—Any feature, other than major or critical. whose failure would likely be noticeable to the user.
4. Incidental characteristic—Any Feature other than critical, major, or minor.

Of course, it is possible to develop classification schemes that are more detailed. However, the above definitions suffice for the vast majority of applications. Most often classifications of critical characteristics are noted on the drawing as well as in the manufacturing plan, as well as in such other ways as to give the user ample warning of potential hazards.

A classification of defects is the enumeration of possible defects of the unit of product classified according to their seriousness.

1. Defect—Any nonconformance of the unit of the product with specified requirements.
2. Defective—A product with one or more defects.
3. Critical defect—A critical defect is a defect that judgment and experience indicate would result in hazardous or unsafe conditions for individuals using, maintaining. or depending upon the product or at defect that judgment and experience indicate is likely to prevent the performance of the tactical function of a major end item such as cars, trucks, Ship, aircraft. tank, missile. or space vehicle.
4. Critical defective—A critical detective is a unit of Product that contains one or more critical defects and may also contain major and/or minor defects.
5. Major defect—A major defect is a defect, other than critical, that is likely to result in failure or to reduce materially the usability of the unit of product For its intended purpose.
6. Major defective—A major defective is a unit of product that contains one or more major defects and may also contain minor defects but contains no critical defects.
7. Minor defect—A minor defect is a defect that is not likely to reduce materially the usability of the unit of product for its intended purpose or is a departure From established standards having little bearing on the effective use or operation of the unit.
8. Minor defective—A minor defective is a unit of product that contains one or more minor defects but contains no critical or major defect.

Design Review and Qualification

A great deal of what We learn comes from experience. The more we do a thing, the more we learn about doing it better. As a corollary, when something is new or untried we tend to make more mistakes. Design review and qualification are performed to apply the lessons learned from experience with other products and projects to the new situation. The objective is to introduce the new item with a minimum of startup problems, errors, and engineering changes. This involves such activities as:

• Locating qualified suppliers
• Identifying special personnel, equipment, handling, storage, quality, and regulatory requirements
• Providing information to marketing for forecasting, promotional. and public-relations purposes.

The design review and qualification activity is usually performed after the development of an acceptable prototype and before full—scale production. Design review often takes place in formal and informal meetings involving manufacturing, quality, and engineering personnel. In some cases, customer personnel are also present. The meetings involve the discussion of preliminary engineering drawings and design concepts. The purpose is to determine if the designs can be produced (or procured) and inspected within the cost and schedule constraints set by management. If not, one of two courses of action must be taken: 1) change the design or 2) acquire the needed production or inspection capabilities. The design review is commonly where critical and major characteristics are identified. This information is used to design functional test and inspection equipment, as well as to focus manufacturing and quality efforts on high—priority items. Formal Failure Mode, Effects and Criticality Analysis (FMECA), and Fault Tree Analysis (FTA) is also performed to assist in identification of important features. When feasible. a pilot run will be scheduled to confirm readiness for full-scale production. Pilot runs present an excellent opportunity for process capability analysis (PCA) to verify that the personnel, machines, tooling, materials, and procedure can meet the engineering requirements. The pilot run usually involves a small number of parts produced under conditions that simulate the full—scale production environment. Parts produced in the pilot run are subject to intense scrutiny to determine any shortcomings in the design, manufacturing, or quality plans. Ideally, the pilot run will encompass the entire spectrum of production, from raw materials to storage to transportation, installation, and operation in the field. Properly done, design review and qualification will result in a full-scale production plan that will minimize startup problems, errors, and engineering changes after startup. The production plan will include error-free engineering drawings, a manufacturing plan, and a quality plan. .

Process Qualification and Validation Methods

Process qualification and validation primarily control issues. One objective is to identify those processes that are capable of meeting management and engineering requirements if properly controlled. Another objective is to assure that processes are actually performing at the level which they are capable of performing, This requires that process capability be analyzed using statistical methods and that products are produced only on those processes capable of holding the required tolerances.

Dimensions of quality

In addition to quality parameters there are three dimensions of quality

• The business quality dimension. This is the extent to which the business services the needs of society. Customers are not only interested in the quality of particular products and services but judge suppliers by the general level of quality products they provide and continuity of supply, their care of the environment, and their adherence to health, safety, and legal regulations.
• The product quality dimension. This is the extent to which the products and service provided meet the needs of specific customers.
• The organization quality dimension. This is the extent to which the organization maximizes its efficiency and effectiveness, achieving minimum waste, efficient management, and good human relations Companies that do not operate efficiently or do not meet their employees‘ expectations will generally find their failure costs to be high and will lose their best people. This directly affects all aspects of quality.

Many organizations only concentrate on the product quality dimension, but the three are interrelated and interdependent. Deterioration in one leads to a deterioration in the others, perhaps not immediately but eventually. As mentioned previously, it is quite possible for an organization to satisfy the customers for its products and services and fail to satisfy the needs of society. Within an organization, the working environment may be oppressive — there may be political infighting and the source of revenue so secure that no effort is made to reduce waste. Even so, such organizations may produce products and services which satisfy their customers. We must separate these three concepts to avoid confusion.

There are three primary organization levels: the enterprise level, the business level, and the operations level‘. Between each level there are barriers. At the enterprise level, the executive management responds to the voice of ownership and is primarily concerned with profit, return on capital employed, market share, etc. At the business level, the managers are concerned with products and services and hence respond to the voice of the customer. At the operational level, the middle managers, supervisors, operators, etc. focus on processes that produce products and services and hence respond to the voice of the processes carried out within their own function. In reality, these levels overlap, particularly in small organizations. The CEO of a small company will be involved at all three levels whereas, in the large multinational, the CEO spends all of the time at the enterprise level, barely touching the business level, except when major deals with potential customers are being negotiated. Once the contract is won, the CEO of the multinational may confine his/her involvement to monitoring performance through metrics and goals. Quality should be a strategic issue that involves the owners as it delivers fiscal performance. Low quality will cause fiscal performance ultimately to decline. The typical focus for a quality system is at the operations level. It is seen as an initiative for work process improvement. The documentation is often developed at the work process level and focused on functions. Much of the effort is focused on the processes within the functions rather than across the functions and only involves the business level at the customer interface, as illustrated in Table:.

Quality management

The basic goal of quality management is the elimination of failure: both in the concept and in the reality of our products, services, and processes. In an ideal world, if we could design products, services, and processes that could not fail we would have achieved the ultimate goal. Failure means not only that products, services, and processes would fail to fulfill their function but that their function was not what our customers desired. Hence quality management is a means for planning, organizing, and controlling the prevention of failure. All the tools and techniques that are used in quality management services to improve our ability to succeed in our pursuit of excellence. Quality does not appear by chance, or if it does it may not be repeated. One has to design quality into the products and services. It has often been said that one cannot inspect the quality of a product. A product remains the same after inspection as it did before, so no amount of inspection will change the quality of the product. However, what inspection does is measure quality in a way that allows us to make decisions on whether to release a piece of work. Work that passes inspection should be quality work but inspection unfortunately is not 100% reliable. Most inspection relies on the human judgment of the inspector and human judgment can be affected by many factors, some of which are outside our control (such as the private life, health, or mood of the inspector).

Several methods have evolved to achieve, sustain, and improve quality, they are quality control, quality improvement, and quality assurance, which collectively are known as quality management.

Quality control (QC)

Quality control is the operational techniques and activities that are used to fulfill requirements for quality. This implies that any activities, whether sewing the improvement, control, management, or assurance of quality, could be a quality control activity. They prevent change and when applied to quality regulate quality performance and prevent undesirable changes in the quality standards. Quality control is a process for maintaining standards and not for creating them. Standards are maintained through a process of selection, measurement, and correction of work, so that only those products or services that emerge from the process meet the standards. In simple terms, quality control prevents undesirable changes from being present in the quality of the product or service being supplied. The simplest form of quality control is illustrated Quality control can be applied to particular products, to processes that produce the products, or to the output of the whole organization by measuring the overall quality performance of the organization. Quality control is often regarded as a post-event activity: i.e. a means of detecting whether quality has been achieved and taking action to correct any deficiencies. However, one can control results by installing sensors before, during, or after the results are created. It all depends on where you install the sensor, what you measure, and the consequences of failure. Some failures cannot be allowed to occur and so must be prevented from happening through rigorous planning and design. Other failures are not so critical but must be corrected immediately using automatic controls or mistake-proofing. Where the consequences are less severe or where other types of sensors are not practical or possible human inspection and test can be used as a means of detecting the failure. Where the failure cannot be measured without observing trends over longer periods, you can use information controls. They do not stop immediate operations but may well be used to stop further operations when limits are exceeded. The progressive development of controls from having no control of quality to installing controls at all key stages from the beginning to the end of the life cycle is illustrated in Figure below As can be seen, if you have no controls, quality products are produced by chance and not design. The more controls you install the more certain you are of producing products of consistent quality but there is a need for balance to be achieved.

It is often deemed that quality assurance serves prevention and quality control detection, but a control installed to detect failure before it occurs serves prevention, such as reducing the tolerance band to well within the specification limits. So quality control can prevent failure. Assurance is the result of an examination whereas control produces the result. Quality assurance does not change the product, quality control does. “Quality control” is also the term used as the name of a department. In most cases, Quality Control Departments perform inspection and test activities and the name derives from the authority that such departments have been given. They sort good products from bad products and authorize the release of the good products. It is also common to find that Quality Control Departments perform supplier control activities, which are called Supplier Quality Assurance or Vendor Control. In this respect, they are authorized to release products from suppliers into the organization either from the supplier’s premises or on receipt in the organization. In recent times the inspection and test activities have been transferred into the production departments of organizations, sometimes retaining the labels and sometimes reverting to the inspection and test labels. Control of quality, or anything else for that matter, can be accomplished by the following steps:

1. Determine what parameter is to be controlled.
2. Establish its criticality and whether you need to control before, during, or after results are produced.
3. Establish a specification for the parameter to be controlled which provides limits of acceptability and units of measure.
4. Produce plans for control which specify the means by which the characteristics will be achieved and variation detected and removed.
5. Organize resources to implement the plans for quality control.
6. Install a sensor at an appropriate point in the process to sense variance from specification.
7. Collect and transmit data to a place for analysis.
8. Verify the results and diagnose the cause of variance.
9. Propose remedies and decide on the action needed to restore the status quo.
10. Take the agreed action and check that the variance has been corrected.

Quality improvement (Ql)

Quality improvement is the actions taken throughout the organization to increase the effectiveness of activities and processes to provide added benefits to both the organization and its customers. In simple terms, quality improvement is anything that causes a beneficial change in quality performance. There are two basic ways of bringing about improvement in quality performance. One is by better control and the other by raising standards. We don’t have suitable words to define these two concepts. Doing better what you already do is an improvement but so is doing something new. Juran uses the term control for maintaining standards and the term breakthrough for achieving new standards. Imai uses the term improvement when change is gradual and innovation when it is radical. Hammer uses the term re-engineering for radical changes. All beneficial change results in improvement, whether gradual or radical. Quality improvement (for better control) is about improving the rate at which an agreed standard is achieved. It is therefore a process for reducing the spread of variation so that all products meet agreed standards. The performance of products or processes may vary due to either random or assignable causes of variation. By investigating the symptoms of failure and determining the root cause, the assignable causes can be eliminated and the random causes reduced so that the performance of processes becomes predictable. A typical quality improvement of this type might be to reduce the spread of variation in a parameter so that the average value coincides with the nominal value (i.e. bring the parameter under control). Another example might be to reduce the defect rate from 1 in 100 to 1 in 1,000,000. Another might be simply to correct the weaknesses in the registered quality system so that it will pass reassessment.

Quality improvement (innovation), is about raising standards and setting a new level. New standards are created through a process that starts at a feasibility stage and progresses through research and development to result in a new standard, proven for repeatable applications. Such standards result from innovations in technology, marketing, and management. A typical quality improvement might be to redesign a range of products to increase the achieved reliability from 1 failure every 5,000 hours to 1 failure every 100,000 hours. Another example might be to improve the efficiency of the service organization so as to reduce the guaranteed call-out time from the specified 36 hours to 12 hours. The transition between where quality improvement stops and quality control begins is where the level has been set and the mechanisms are in place to keep quality on or above the set level. In simple terms, if quality improvement reduces quality costs from 25% of turnover to 10% of turnover, the objective of quality control is to prevent the quality costs from rising above 10% of turnover. Improving quality by raising standards can be accomplished by the following steps:

1. Determine the objective to be achieved, e.g. new markets, products, or technologies, or new levels of organizational efficiency or managerial effectiveness, new national standards, or government legislation. These provide the reasons for needing change.
2. Determine the policies needed for improvement, i.e. the broad guidelines to enable management to cause or stimulate the improvement.
3. Conduct a feasibility study. This should discover whether accomplishment of the objective is feasible and propose several strategies or conceptual solutions for consideration. If feasible, approval to proceed should be secured.
4. Produce plans for the improvement which specify the means by which the objective will be achieved.
5. Organize the resources to implement the plan.
6. Carry out research, analysis, and design to define a possible solution and credible alternatives.
7. Model and develop the best solution and carry out tests to prove it fulfills the objective.
8. Identify and overcome any resistance to the change in standards.
9. Implement the change, i.e. put new products into production and new services into operation.
10. Put in place the controls to hold the new level of performance.

This improvement process will require controls to keep improvement projects on course towards their objectives. The controls applied should be designed in the manner described previously.

Quality assurance (QA)

Quality assurance is all those planned and systematic actions necessary to provide adequate confidence that an entity will fulfill requirements for quality. Both customers and managers have a need for quality assurance as they are not in a position to oversee operations for themselves. They need to place trust in the producing operations, thus avoiding constant intervention. Customers and managers need:

1. Knowledge of what is to be supplied. (This may be gained from the sales literature, contract, or agreement.)
2. Knowledge of how the product or service is intended to be supplied. (This may be gained from the supplier’s proposal or offer.)
3. The knowledge that the declared intentions will satisfy customer requirements if met. (This may be gained from personal assessment or reliance on independent certifications.)
4. The knowledge that the declared intentions are actually being followed. (This may be gained by personal assessment or reliance on independent audits.)
5. The knowledge that the products and services meet your requirements. (This may be gained by personal assessment or reliance on independent audits.)

You can gain assurance of quality by testing the product/service against prescribed standards to establish its capability to meet them. However, this only gives confidence in the specific product or service purchased and not in its continuity or consistency during subsequent supply. Another way is to assess the organization that supplies the products/services against prescribed standards to establish its capability to produce products of a certain standard. This approach may provide assurance of continuity and consistency of supply. Quality assurance activities do not control quality, they establish the extent to which quality will be, is being, or has been controlled. Quality control concerns the operational means to fulfill quality requirements, and quality assurance aims at providing confidence in this fulfillment both within the organization and externally to customers and authorities. All quality assurance activities are post-event activities and off-line and serve to build confidence in results, in claims, in predictions, etc. Quite often, the means to provide the assurance need to be built into the process, such as creating records, documenting plans, documenting specifications, reporting reviews, etc. Such documents and activities also serve to control quality as well as assure it  Assurance is not an action but a result. It results from obtaining reliable information that testifies the accuracy or validity of some event or product.  Quality Assurance Departments are often formed to provide both customer and management with confidence that quality will be, is being, and has been achieved. However, another way of looking upon Quality Assurance Departments is Corporate Quality Control. Instead of measuring the quality of products, they are measuring the quality of the business and by doing so are able to assure management and customers of the quality of products and services. Assurance of quality can be gained by the following steps

1. Acquire the documents that declare the organization’s plans for achieving quality.
2. Produce a plan that defines how an assurance of quality will be obtained, i.e. a quality assurance plan.
3. Organize the resources to implement the plans for quality assurance.
4. Establish whether the organization’s proposed product or service possesses characteristics which will satisfy customer needs.
5. Assess operations, products, and services of the organization and determine where and what the quality risks are.
6. Establish whether the organization’s plans make adequate provision for the control, elimination, or reduction of the identified risks.
7. Determine the extent to which the organization’s plans are being implemented and risks contained.
8. Establish whether the product or service being supplied has the prescribed characteristics.

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