Automotive Quality Systems Handbook Episode 4 docx

Such improvements may improve the quality of design, quality of conformance, or quality of use see Part 1 Chapter 1 under Quality parameters or may cause a tion in cost while not providi

seriously unless they have a particular issue they want to bring to your attention It ismuch better to talk face to face with your customer using an interview checklist Thinkfor a moment how a big customer like Ford or GM would react to thousands of ques-tionnaires from their suppliers They would either set up a special department just todeal with the questionnaires or set a policy that directs staff not to respond to supplierquestionnaires Economics alone will dictate the course of action customers will take.

A customer satisfaction index (CSI) that is derived from data from an independentsource would indeed be more objective Such schemes are in use in North America,Sweden, and Germany A method developed by a Professor Claes Fornell has been inoperation for 12 years in Sweden and is now being used at the National QualityResearch Center of the University of Michigan Business School Called the AmericanCustomer Satisfaction Index (ACSI) it covers seven sectors, 40 industries, and some 200companies and government agencies It is sponsored by the ASQC and the University

of Michigan Business School with corporate sponsorship from AT&T, General Motors,and others Using data obtained from customer interviews, sector reports are publishedindicating a CSI for each listed organization, thereby providing a quantitative and inde-pendent measure of performance useful to economists, investors, and potentialcustomers A pan-European scheme is being developed through EOQ and is currently

on trial

Frequency of measurement

Frequency also needs to be adjusted following changes in models and major changes inorganization structure, such as mergers, downsizing, and plant closures Changes infashion and public opinion should also not be discounted Repeating the survey afterthe launch of new technology, new legislation, or changes in world economics affectingthe automotive industry may also affect customer perception and hence satisfaction

Trends

To determine trends in customer satisfaction and dissatisfaction you will need to makeregular surveys and plot the results, preferably by particular attributes or variables Thefactors will need to include quality characteristics of the product or service as well asdelivery performance and price The surveys could be linked to your improvement pro-grams so that following a change, and allowing sufficient time for the effect to beobserved by the customer, customer feedback data could be secured to indicate theeffect of the improvement

Customer dissatisfaction will be noticeable from the number and nature of customercomplaints collected and analyzed as part of your corrective action procedures (seePart 2 Chapter 14) This data provides objective documentation or evidence and againcan be reduced to indices to indicate trends

By targeting the final customer using data provided by intermediate customers, you will

be able to secure data from the users but it may not be very reliable A nil return will notindicate complete satisfaction so you will need to decide whether the feedback is signif-icant enough to warrant attention Using statistics to make decisions in this case may not

be a viable approach since you will not possess all the facts!

Considering internal and external customers (4.1.1.3)

The note attached to clause 4.1.1.3 needs to be interpreted carefully otherwise you willhave every individual setting up systems to monitor their relationship with the people towhom they provide product or information Everyone needs to be aware of their rela-tionships with others but formal systems are only necessary between organizations Ifyour organization receives formal orders from other parts of the same company thenthere may be benefit in treating this as a customer-supplier relationship and monitoringcustomer satisfaction

It is common when adopting the TQM philosophy to regard all human interfaces ascustomer-supplier interfaces When executed wisely this can have a beneficial effect oninternal efficiency and effectiveness, but there are pitfalls to avoid In a customer-supplier chain, the expectations of the external customer can be modified with eachtransaction, as illustrated in Figure 1.2

External

What we think the customer ordered

External

Exactly what the customer ordered

Calibration of requirements

Inside the organizationInside the organization

Figure 1.2 Internal customer-supplier relationships

In the upper diagram each supplier individually interprets the customer’s requirementsand either imposes additional requirements or neglects to pass on requirements The netresult at the end of the chain is that the external customer (the one who buys from theorganization) does not get satisfaction from the transaction In the lower diagram, eachsupplier refers back to the external customer’s requirements to calibrate the internal cus-tomer’s demands This ensures that the net result matches exactly what the customerordered In reality, such calibration should not be necessary if the internal customersdemonstrate traceability to external customer requirements This can be achievedthrough process reviews performed in each process before instructions are transmitted

Ambiguity in the requirement

It has become fashionable to use the term continuous improvement rather than ual improvement Continuous means without breaks or interruption – such ascontinuous stationery Continual means repeated regularly and frequently – a term thatfits the concept of improvement rather better and will be used in ISO 9000:2000.The first two statements in clause 4.1.1.4 create an ambiguity when read together Thefirst calls for improvements in quality, service, cost, and technology (but not productivi-ty) to be provided for in the quality policy but not implemented and the second calls forimprovement in quality and productivity to be identified and implemented with no men-tion of cost, service, or technology

contin-Quality, service, cost, and technology are not mutually exclusive One can’t distinguishbetween a quality improvement and a service or technology improvement It was nec-essary only to mention quality and cost, as an improvement in service must be animprovement in either the quality or cost of the service – all other factors come withinthe definition of quality Improvements in technology are also improvements in quality

or cost Such improvements may improve the quality of design, quality of conformance,

or quality of use (see Part 1 Chapter 1 under Quality parameters) or may cause a tion in cost while not providing any change in product or service characteristics

reduc-Productivity is a measure of productive efficiency calculated as the ratio of what is duced to what is required to produce it Productivity can therefore be considered as acharacteristic of a process, and therefore a measure of the quality of a process Considertwo process each producing the same product but one delivers the result using lessresources and hence as a consequence has a higher productivity The process with thehigher productivity could thus be regarded as being of better quality However, measur-ing resource consumption alone would not be a valid means of comparison as inputscould be vastly different Hence productivity is a quality characteristic.

pro-¢

¢ If you are not maintaining or improving quality, delivery, or cost, theaction you are taking adds no value

Improvements in product quality

Improvement in business performance is essential for growth and profit, but theISO/TS 16949 requirements are not concerned with your growth and profits; they areconcerned with product quality, and one definition of product quality that signalsimprovement potential is “freedom from defects” Achieving quality become a quest toeliminate defects and in so doing reduces variation in the operational processes, buteven when there are no defectives, there will still be variation One might well questionthe need to reduce variation when there are no defectives but by reducing variation youwill have fewer breakdowns, fewer errors, less space allocated to inventory, less waste,etc.: in fact fewer problems and increased profit as a result

The starting point in building this system of values is self analysis It is of little use todeclare a policy of continual improvement if the will to implement it does not exist Manyorganizations are content to meet the specification every time and, once achieved,believe they have made all the improvement to which resources should be committed.There are four questions that each manager should be able to answer:

l Can we make it OK?

l Are we making it OK?

l Have we made it OK?

l Could we make it better?

Meeting the specification every time means that you have obtained satisfactory answers

to the first three questions – but why stop there? Could you make it better? Often theanswer is “yes” but it will cost a lot of money and after all, why should we want to make

it better? Some reasons for pursuing improvement beyond achievement to specificationare given in Part 1 Chapter 1 on the subject of Quality goals.

Improvement on cost

The price charged for products is a function of cost, profit, and what the market will pay.Sometimes price is much higher than cost and in other cases only slightly higher

¢

¢ Control change and you control cost

In your particular business, it may be profitable to sell some products below cost as anenticement to capture further business where you can make more profit This will create

a force to drive down costs Remember that if you control change you control cost, sothe more stable your processes the less they cost

If you find that you cannot absorb increases in labor and raw material costs, then youmay have to look for alternative approved sources, alternative materials, alternativemethods or consider alternative designs By including price in the improvement formu-

la, it will act as a driving force

Improvements in productivity

Your general aim should be to improve product quality, increase productivity, andreduce the cost of development and manufacture However, productivity is not easy tomeasure with multiple products on multiple lines, each at a different stage of maturity.This makes comparisons to detect changes in productivity difficult, if not impossible.However there may be factors common to all product lines, such as labor costs Merelyoutsourcing manufacture to developing countries may not improve your productivity.The labor costs may reduce but rework and warranty claims increase Productivity isonly improved if product quality has been maintained Certain processes may also becommon to more than one product line and hence improving productivity of commonprocesses can have wide-ranging impact

Time is also a resource and therefore reducing cycle time impacts productivity Often theadministration and design processes are a source rich in cycle time improvements, such

as the time taken to change a document, a design, a policy, etc or the time taken toplace an order, arrange a training course, authorize budgets and expenditure, etc.Reaction time is also important as in servicing, maintenance, customer support, etc.How long does it take to get management to react to a situation that requires their atten-

tion? There are priorities of course, but question these priorities if you believe they der continuous improvement!

hin-A need for productivity improvement may arise because your standards were made ficult to achieve although possible to attain As a result this has the effect of encouraginginitiative and resourcefulness and using the capabilities of your personnel Manyimprovement opportunities will be identified by those who are eager to seek easier ways

dif-of doing things

Opportunities for improvement can be identified through:

l Process and product measurement systems

identi-Use of appropriate improvement methodologies (4.1.1.4)

The standard requires the use of appropriate continuous improvement measures andmethodologies

A list showing examples of possible continuous improvement techniques is included inthe standard These techniques and many more are defined in Appendix A and a bibli-ography is provided in Appendix C

In demonstrating knowledge of these techniques an auditor would be looking for dence that:

evi-l Staff have received adequate training in continuous improvement methodologies

l Information is available to enable staff to select and use the appropriate techniques

l The technique to be used for identifying improvement opportunities is specified foreach quality objective

Just because a technique exists does not imply that you have to use it, but you shouldunderstand the advantages and disadvantages of using a particular technique

Responsibility and authority (4.1.2.1)

The requirements on responsibility and authority are in two parts: one general and theother relating to people with particular roles Each is treated separately

Identifying work that affects quality (4.1.2.1.1)

The standard requires that the responsibility, authority, and interrelation of personnelwho manage, perform, and verify work affecting quality be defined and documented.The key to this requirement is determining what work affects quality; i.e if you can iden-tify any work that does not affect quality, you are not obliged to define in your qualitysystem the responsibilities and authority of those who manage, perform, or verify it

In principle, everyone’s work affects the quality of the products and services supplied bythe organization, some directly, others indirectly Work can be divided into result-producing, support, and housekeeping activities All are essential to the business butonly the result-producing and support activities affect the quality of the products andservices supplied The result-producing activities are those which directly bring in rev-enue and which contribute to results, such as sales, marketing, development,manufacture, and maintenance The support activities are usually those which set stan-dards, create vision, produce information needed by the result-producers, provideteaching, training, and advice, such as research, computer services, quality assurance,training, and personnel Housekeeping activities are those which do not contribute toresults but their malfunction could harm the business, such as health and safety, securi-

ty, catering, travel, medical, general maintenance, etc

Apart from result-producing activities, there are several other activities that could affectquality:

l A failure to observe government health and safety regulations could close a factoryfor a period and hence result in late delivery to customers

l Health and safety hazards could result in injury or illness, place key personnel out

of action for a period, and hence result in work not being done or being done bypersonnel who are not competent

l A failure to take adequate personnel safety precautions may put product at risk

l A failure to safely dispose of hazardous materials and observe fire precautions couldput plant at risk

If there are personnel involved with the identification, interpretation, promulgation, andverification of such regulations then their responsibilities and authority will need to bedefined in the quality system

What is “responsibility and authority”?

Defining the responsibility and authority of personnel can be achieved in several waysbut first let’s look at what we mean by responsibility and authority

Responsibility is in simple terms an area in which one is entitled to act on one’s ownaccord It is the obligation of staff to their managers for performing the duties of theirjobs It is thus the obligation of a person to achieve the desired conditions for which theyare accountable to their managers If you caused something to happen, you must beresponsible for the result just as you would if you caused an accident – so to determine

a person’s responsibility, ask “What can you cause to happen?”

Authority is in simple terms the right to take actions and make decisions In the agement context it constitutes a form of influence and a right to take action, to directand coordinate the actions of others, and to use discretion in the position occupied by

man-an individual, rather thman-an in the individual themselves The delegation of authority mits decisions to be made more rapidly by those who are in more direct contact with theproblem

per-It is necessary for management to define who should do what in order that the nated work is assigned to someone to carry out It is not cost effective to have duplicateresponsibilities or gaps in responsibility as this leads to conflict or tasks being overlooked

desig-A person’s job can be divided into two components: actions and decisions.Responsibilities and authority should therefore be described in terms of the actionsassigned to an individual to perform and discretion delegated to an individual: that is,the decisions they are permitted to take along with the freedom they are permitted toexercise Each job should therefore have core responsibilities, which provide a degree ofpredictability, and innovative responsibilities, which in turn provide the individual withscope for development.

In defining responsibilities and authority there are some simple rules that you should low:

fol-l Through the process of delegation, authority is passed downward within the ization and divided among subordinate personnel, whereas responsibility passesupwards

organ-l A manager may assign responsibilities to a subordinate and delegate authority;however, they remain responsible for the subordinate’s use of that authority

l When managers delegate responsibility for something, they remain responsible for

it When managers delegate authority they lose the right to make the decisions theyhave delegated but remain responsible and accountable for the way such authority

is used Accountability is one’s control over the authority one has delegated to one’sstaff

l It is considered unreasonable to hold a person responsible for events caused by tors that they are powerless to control

fac-l Before a person can be in a state of control they must be provided with three things:i) Knowledge of what they are supposed to do: i.e the requirements of the job,the objectives they are required to achieve

ii) Knowledge of what they are doing, provided either from their own senses orfrom an instrument or another person authorized to provide such data.iii) Means of regulating what they are doing in the event of failing to meet the pre-scribed objectives These means must always include the authority to regulateand the ability to regulate both by varying the person’s own conduct and byvarying the process under the person’s authority It is in this area that freedom

of action and decision should be provided

l The person given responsibility for achieving certain results must have the right (i.e.the authority) to decide how those results will be achieved; otherwise, the responsi-bility for the results rests with those who stipulate the course of action.

l Individuals can rightfully exercise only that authority which is delegated to them andthat authority should be equal to that person’s responsibility (not more or less thanit) If people have authority for action without responsibility, it enables them to walk

by problems without doing anything about them Authority is not power itself It isquite possible to have one without the other! A person can exert influence withoutthe right to exert it

l In the absence of the delegation of authority and assignment of responsibilities, viduals assume duties that may duplicate those duties assumed by others Thus jobsthat are necessary but unattractive will be left undone It also encourages decisions

indi-to be made only by indi-top management, resulting in an increasing management load and engendering a feeling of mistrust in the workforce

work-Defining responsibilities and authority (4.1.2.1.1)

ISO 9001 requires responsibilities and authority to be documented in addition to beingdefined, as one can define such things in dialog with one’s staff without documentingthem This is indeed a common way for staff to discover their responsibilities.Sometimes you may not be aware of the limits of your authority until you overstep themark By documenting the responsibility and authority of staff, managers should be able

to avoid such surprises

There are four principal ways in which responsibilities and authority can be ed:

document-l In an organization structure diagram, or organigram

l In job descriptions

l In terms of reference

l In procedures

The standard does not stipulate which method should be used In very small companies

a lack of such documents defining responsibility and authority may not prove mental to quality provided people are made aware of their responsibilities andadequately trained However, if you are going to rely on training, there has to be somewritten material which is used so that training is carried out to consistent standards

detri-Organigrams are a useful way of showing interrelationships (see below) but imprecise as

a means of defining responsibility and authority They do illustrate the lines of

authori-ty and accountabiliauthori-ty but only in the chain of command Although organigrams candefine the area in which one has authority to act, they do not preclude others havingresponsibilities within the same area; for example, the title “Design Manager – ComputerProducts” implies the person could be responsible for all aspects of computer productdesign when in fact they may not have any software, mechanical engineering, or relia-bility engineering responsibilities Titles have to be kept brief as they are labels forcommunication purposes and are not usually intended for precision on the subject ofresponsibilities and authority One disadvantage of organigrams is that they do not nec-essarily show the true relationships between people within the company Horizontalrelationships can be difficult to depict with clarity in a diagram They should thereforenot be used as a substitute for policy

Job descriptions or job profiles are useful in describing what a person is responsible for;however, it rather depends upon the reason for having them as to whether they will be

of any use in managing quality Those produced for job evaluation, recruitment, salarygrading, etc may be of use in the quality system if they specify the objectives people areresponsible for achieving and the decisions they are authorized to take

Terms of reference are not job descriptions but descriptions of the boundary conditions.They act as statements that can be referred to in deciding the direction in which oneshould be going and the constraints on how to get there They are more like rules than

a job description and more suited to a committee than an individual They rarely coverresponsibilities and authority except by default

Procedures are probably the most effective way of defining people’s responsibilities andauthority as it is at the level of procedures that one can be specific as to what someone

is required to do Procedures specify individual actions and decisions By assigningactions or decisions to a particular person you have assigned to them a responsibility orgiven them certain authority Procedures do present problems however It may be diffi-cult for a person to see clearly what his/her job is by scanning the various proceduresbecause procedures often describe tasks rather than objectives When writing proce-dures never use names of individuals as they will inevitably change The solution is touse position or role titles and have a description for a particular position or role that cov-ers all the responsibilities assigned through the procedures Individuals only need toknow what positions they occupy or roles they perform Their responsibilities andauthority are clarified by the procedures and the position or role descriptions1

1 An explanation of roles and the advantages of applying the concept of roles in a quality system is given in the ISO 9000 Quality System Development Handbook by David Hoyle (Butterworth-Heinemann, 1998).

Within ISO/TS 16949 there are several requirements for an assignment of responsibility.These include the responsibility and authority for:

l Defining the quality policy and objectives (clauses 4.1.1.1 and 4.1.1.2)

l Determining customer satisfaction (clause 4.1.1.3)

l Representing the needs of the customer (clause 4.1.2.1.2)

l Stopping production to correct quality problems (clause 4.1.2.1.3)

l Assigning trained personnel (clause 4.1.2.2.1)

l Appointing the management representative (clause 4.1.2.3)

l Reviewing business plans (clause 4.1.4)

l Promoting quality awareness (clause 4.1.6)

l Promoting safety awareness (clause 4.1.7.1)

l Conducting the management review (clause 4.1.3.1)

l Quality planning (clause 4.2.3.1)

l Assigning the project manager (clause 4.2.4.1)

l Reporting product realization measurements to management (clause 4.2.4.2)

l Conducting project reviews (clause 4.2.4.3)

l Carrying out FMEA (clause 4.2.4.5)

l Performing process studies (clause 4.2.4.5)

l Performing process design verification (clause 4.2.4.9.4)

l Developing control plans (clause 4.2.4.10)

l Submitting product approval requests (clause 4.2.4.11)

l Accepting contracts (clause 4.3.2.1)

l Reviewing product designs (clause 4.4.6)

l Performing product design verification and validation (clauses 4.4.7 and 4.4.8.1)

l Reviewing product design changes (clause 4.4.9.1)

l Reviewing and approving documents and changes thereto (clauses 4.5.2.1 and4.5.3)

l Evaluating and selecting subcontractors (clause 4.6.2.1)

l Subcontractor assessment (clause 4.6.2.1)

l Reviewing and approving purchasing documents (clause 4.6.3)

l Verifying product at subcontractor’s premises (clause 4.6.4.1)

l Reporting lost or unsuitable customer supplied product to customers (clause 4.7.1)

l Planning production, installation, and servicing processes (clause 4.9.1.1)

l Verifying job set-ups (clause 4.9.4)

l Verifying product (clauses 4.10.2, 4.10.3, and 4.10.4)

l Performing layout inspection (clause 4.10.4.2)

l Checking comparative references (clause 4.11.1.1)

l Calibrating inspection, measuring, and test equipment (clause 4.11.2)

l Notifying customers of nonconforming product shipment (clause 4.13.1.3)

l Reviewing and disposing of nonconforming product (clause 4.13.2)

l Obtaining authorization to deviate from customer approved specifications (clause4.13.4)

l Handling customer complaints (clause 4.14.2.1)

l Investigating the cause of nonconforming product (clause 4.14.2.1)

l Determining corrective and preventive actions (clauses 4.14.2.1 and 4.14.3)

l Receiving product into and dispatching product from storage areas (clause 4.15.3.1)

l Issuing shipment notifications to customers (clause 4.15.6.5)

l Planning, conducting, and reporting on internal quality audits (clause 4.17.1)

l Identifying training needs and providing training (clause 4.18.1)

l Reviewing training effectiveness (clause 4.18.2)

l Reporting that servicing meets requirements (clause 4.19.1)

l Identifying the need for statistical techniques (clause 4.20.1)

In organizations that undertake projects rather than operate continuous processes orproduction lines, there is a need to define and document project-related responsibilitiesand authority These appointments are often temporary, being only for the duration ofthe project Staff are assigned from the line departments to fulfill a role for a limited peri-

od To meet the requirement for defined responsibility, authority, and interrelationshipsfor project organizations you will need Project Organization Charts and Project JobDescriptions for each role (such as Project Manager, Project Design Engineer, ProjectSystems Engineer, and Project Quality Engineer)

As project structures are temporary, there needs to be a system in place that controls theinterfaces between the line functions and project team Such a system would include:

l Policies that govern the allocation of work to projects

l Policies that govern the allocation of work to staff on these projects

l Job descriptions for each role, stating responsibilities, authority, and accountability

l Procedures that identify the roles responsible for each task and for ensuring thatinformation is conveyed to and from these staff at the appropriate time

l Procedures that consolidate information from several disciplines for transmission tothe customer when required

l Monitoring procedures to track progress and performance

l Procedures that ensure the participation of all parties in decisions affecting the uct and its development and production

prod-l Procedures for setting priorities and securing commitment

l Procedures that include the management of subcontractor programs during ment and deal with the transmission of information to and from the subcontractors,what is to be transmitted, by whom, in what form, and with whose approval

develop-Some organizations have assigned responsibility for each element of the standard to aperson, but such managers are not thinking clearly For some elements, the assignment

of responsibility may appear possible, as in the case of clause 4.4 on Design control and4.6 on Purchasing, but when you come to examine it more closely you will find that thetask is not so easy If we look at purchasing we find that it is made up of many actionsand decisions, such as defining the technical requirement, evaluating the supplier,choosing the supplier, placing the order, monitoring the supply, inspecting the goods onreceipt, etc No one person other than the CEO is responsible for all of these actions,unless it is a small company The Purchasing Manager may not accept responsibility forerrors in the technical specification invoked in the purchase order if he/she did not pre-pare or approve the technical specification When auditors ask “Who is responsible forpurchasing?” ask them to specify the particular activity they are interested in Rememberyou have a system that delegates authority to those qualified to do the job

Defining the interrelation of personnel (4.1.2.1.1)

Defining individual responsibilities and authority alone will not define how personnelrelate to one another Interrelation means to place in mutual relationship, so what isneeded is a definition of the relationships between all staff with quality responsibilities.The primary reason for defining interrelationships is to establish channels of communi-cation so that work proceeds smoothly without unplanned interruption Staff need toknow from whom they will receive their instructions, to whom they are accountable, towhom they should go to seek information to resolve difficulties, and to whom informa-tion or product should be submitted when complete

Personnel within a company are related in several ways:

l By position in a reporting hierarchy

l By position in a chain of operations as internal customers and suppliers of mation, product, or service

infor-l By position in a salary-grading structure

l By job title, profession, type of work

l By location, i.e being on the same site but not in the same department, group, ordivision

In order for personnel to achieve a common objective (product or service quality) theymust relate to one another – they must interact Work passes from one person to anoth-

er, from one department to another and often this relationship is quite different from thehierarchical relationship of personnel in the company In order to meet this particularrequirement it is therefore necessary to:

l Define the structure of the company, preferably in diagrammatic form showing eachdepartment and section whose work affects quality (You don’t have to define allparts of the company.)

l Define the location of work, departments, groups, and divisions

l Define the processes that manage, specify, achieve, and control product/servicequality and who performs each stage in the process, preferably in the form of flowdiagrams

An organization may respond to these requirements in several ways, so in managing thequality system a list of the documents is needed which contains the definition of peo-ple’s responsibilities and authority The difficulty arises in keeping all such documentscompatible and so it is often better to limit the documents to the three types above, ifpossible

Personnel with organizational freedom (4.1.2.1.1)

The second part of the responsibility and authority requirement requires the supplier todefine the responsibility, authority, and interrelation of personnel who need the organi-zational freedom and authority to:

a) Initiate action to prevent the occurrence of any nonconformities relating to product,process, and quality system

b) Identify and record any problems relating to the product, process, and quality tem

sys-c) Initiate, recommend, or provide solutions through designated channels

d) Verify the implementation of solutions

e) Control further processing, delivery, or installation of nonconforming products untilthe deficiency or unsatisfactory condition has been corrected

Who are these personnel who need organizational freedom and why do they warrant aspecial mention? This is not meant to imply that you should set up a separate qualitydepartment The standard does not in fact require all personnel to have organizationalfreedom but it suggests that some people will need organizational freedom to do certainthings.

Personnel who initiate action to prevent nonconformity (4.1.2.1.1a)

Initiating action to prevent something is not the same as preventing something from ing place You can prevent something from happening either by not starting the process

tak-or by stopping it beftak-ore a nonconftak-ormity has occurred The only people who should vent the occurrence of product or process nonconformity are those in control of theprocess – those operating the machines, producing the results, doing the work – or thosepeople who manage or supervise such people It would not be right for anyone notresponsible for the process to exert power over it, such as stopping the process or chang-ing the material, the documentation, the instructions, or the personnel In addition to themanagers of the process, the management representative and the quality auditorsshould be given the authority to initiate action to prevent nonconformity (i.e the orga-nizational freedom) but if you do this, such authority should override that of those incontrol of the process In other words if the auditor requires some action to be taken toprevent the recurrence of nonconformity, he has to do more than notify those in control

pre-of the process, otherwise such notification could be ignored or any agreement doned The reason for doing this is so that the management representative candischarge responsibility for ensuring that the requirements of the standard are met (seelater in this chapter) Authority to initiate means authority to cause someone to takeaction It does not give the initiator the right to specify what action to take However, thereceiver of the instruction must either obey it or escalate it to higher management.Regarding nonconformities relating to the quality system, anyone should be permitted

aban-to request a change aban-to the quality system documentation aban-to prevent the occurrence ofnonconformities; however, only a person’s manager should be permitted to issueinstructions to his/her staff enforcing compliance with the documented quality system.The management representative can and should, however, instruct other managers tocomply with the agreed policies and practices

Personnel who identify and record problems (4.1.2.1.1b)

A problem is the difference between the way things are and the way things ought to be,

as perceived by the one identifying it A problem relating to the product, process, orquality system (or quality problem) is therefore a difference between what has beenachieved and what is required There is no requirement in this clause for you to actual-

ly identify and record such problems (see below) You are only required to define the

responsibilities and authority of those personnel in your organization who need to tify and record such problems.

iden-Should anyone need organizational freedom and authority to identify and record lems? Any organization should provide an environment which encourages all employees

prob-to contribute prob-to the business, but unfortunately this is not so in many organizations.There may well be some merit in limiting such freedom in order that management is notswamped with fictitious problems It all comes down to deciding who is in a position to

be able to tell whether a situation is a problem and whether it affects quality Certainlymanagers and professional staff should be free to identify problems because they shouldhave the knowledge to report only problems that can be resolved

To provide staff with the necessary organizational freedom you will need one or moreproblem-reporting procedures and some policies that give staff the freedom to identify,record, and report problems relating to the product, process, and quality system.The requirement does not cross refer to clause 4.16 on Quality records, clearly indicat-ing that there is no requirement in this clause for problems to be recorded, as otherclauses such as 4.10, 4.13, and 4.14 cover this However, these clauses only relate toproblems in not meeting the specified requirements and therefore may exclude types ofproblems not governed by specified requirements So having identified the responsibil-ities of these personnel there may be no compulsion to provide a means for suchproblems to be documented, resolved, and prevented from recurrence

Personnel who initiate, recommend, or provide solutions (4.1.2.1.1c)

There is no requirement to implement solutions, only to initiate, recommend, provide,and verify them Initiating, recommending, and providing have three quite differentmeanings Initiating in this context means causing a solution to be implemented and hasmore power than a recommendation, which can be ignored, as can solutions provided

by others Managers of the functions concerned should have authority to initiate tions to problems arising in their areas of responsibility Experts and other personnelused in an advisory capacity should also be given authority to make recommendationsand provide solutions However, you may wish to limit such powers You will not wantjust anyone to influence those resolving the problems Those not qualified to give advice

solu-on certain subjects should not have authority to do so There have been many caseswhere a person has taken unqualified advice to find that they should not have done so.Hence the requirement that solutions be provided through designated channels You willtherefore need some policy to ensure that the credentials of those giving advice arechecked before the advice is accepted Likewise, there should be a policy that ensuresstaff take the advice given by qualified personnel unless they can justify otherwise There

is no point in an organization employing experts and then allowing their advice to beignored If the experts are no good it is better to replace them!

Personnel who verify the implementation of solutions (4.1.2.1.1e)

The person resolving the problem should be the person who caused it or, if this is notpossible or appropriate, it should be the person responsible for the result This personshould also verify that they have implemented the solution correctly, but there may be

a need for others to verify that the solution resolves the problem; for example, the son detecting the problem may be a customer Quite often the solution implementedmay not in fact resolve the original problem This could be due to poor communication

per-or to politics In addition, the designer of the solution may decide to take the oppper-ortu-nity to change things that were perhaps not perfect but found them less costly to change

opportu-in conjunction with other changes Where such changes may result opportu-in the problem notbeing solved, it becomes more important that the verification be carried out by some-one other than the designer You will need to define who has the authority to verifycertain types of solutions, such as new products, design changes, policy changes, plan-ning changes, procedures changes, or process changes They may be the same peoplewho verified the original designs, plans, procedures, etc but could be different if youhave a product support, maintenance, or post-design organization

Personnel who control further processing, delivery,

or installation of nonconforming product (4.1.2.1.1e)

There are three separate requirements here Control of further processing involves ping the process and, as explained previously, should be carried out only by thoseresponsible for the process Controlling further delivery is somewhat different, as theauthority to deliver may not be vested in the same person who performed the process-ing

stop-Delivery decisions are more than decisions about conformance to specification Theyare about conformance to contract and those responsible for the production processesmay not be able to determine whether contractual conditions have been met Muchmore may hang on the resolution of a problem than mere conformance to specification.The decision in some circumstances may be taken by the CEO There may have been

a safety problem or a product liability problem so your system needs to recognize thesefine distinctions Those making the delivery decisions need possession of all the infor-mation required to protect the company as well as meet customer needs

Installation decisions are similar to process decisions and the decision to start or stop ther installation work should rest with those responsible for installation If the materialshave not been delivered they cannot be installed, so the key decision in this case is thedelivery decision

The appointed customer representative will need to spend some time with the customer

to learn their ways, and understand their language, needs, and expectations Hence ifthe native tongue of your staff is English and you do business with Swedish, Italian, andFrench companies you may need people who can speak these languages and who arefamiliar with the appropriate subject vocabulary Beware, however, that in appointingsuch a person you choose wisely It also has to be someone you can trust to representyour interests You will need a means of calibrating this person so that he/she does notget carried away with enthusiasm and start to impose requirements that are no morethan personal likes and dislikes

Quality responsibility (4.1.2.1.3)

Notification of nonconformities (4.1.2.1.3)

The standard requires management with responsibility and authority for correctiveaction to be promptly informed of products or processes which become noncompliantwith specified requirements

The requirement in clause 4.13.1 of ISO 9001 requires the supplier’s nonconformingproduct controls to provide for notifying the functions concerned This supplementary