Ensuring that information is submitted for management review 4.14.3dThe standard requires that the preventive action procedures confirm that the relevantinformation on actions taken incl
Trang 1plished then you have not determined the steps needed to deal with any problemsrequiring preventive action and are therefore noncompliant with ISO 9001.
The action taken during process monitoring (see Part 2 Chapter 9) can be consideredpreventive action when corrections are made to the process ahead of occurring non-conformities Hence Statistical Process Control is a technique which servesnonconformity prevention as well as detection
The steps you need to take to deal with specific problems will vary depending on thenature of the problem The part that can be proceduralized is the planning process fordetermining the preventive action needed A typical process may be as follows:
l Devise a strategy for eliminating the cause together with alternative strategies, theirlimitations and consequences
l Gain agreement on the strategy
l Prepare an improvement plan which if implemented would eliminate the potentialproblem and not cause any others
l Prepare a timetable and estimate resources for implementing the plan
l Gain agreement of the improvement plan, timetable, and resources before goingahead
The procedure would need to define the authority and responsibilities of those involved,the methods used to analyze the data, and the recommended format of any improve-ment plan in order that plans submitted to management gain their agreement Someplans may be very simple and require no more than an instruction to implement anexisting procedure Others may be more involved and require additional resources Theimprovement plan should be seen as defining a quality objective and hence if a majorchange in performance is necessary, should be part of your Improvement Plan, whichwas addressed in Part 2 Chapter 1 In this way you are seen to operate a coherent andcoordinated improvement strategy rather than a random and unguided strategy Whilethose on the firing line are best equipped to notice the trends any preventive actionshould be coordinated in order that the companys resources are targeted at the prob-lems which are most significant
Mistake-proofing (4.14.3b and 4.14.1.3)
The standard requires the supplier to use mistake-proofing in corrective and preventiveaction process
Trang 2Mistake-proofing is a means to prevent the manufacture or assembly of nonconformingproduct All people make mistakes Mistakes are inadvertent errors and arise throughhuman fallibility We all occasionally forget things and we can either make actions mistake-proof in order that they can only be performed one way or we can provide signals toremind us of what we should be doing The terms fool-proofing and Poka-Yoke (coined
by Shigeo Shinto) are also used to describe the same concepts
Mistake-proofing can be accomplished by product design features in order that the sibility of incorrect assembly, operation, or handling is avoided In such cases therequirements for mistake-proofing need to form part of the design input requirementsfor the part
pos-Mistake-proofing can also be accomplished by process design features such as sensors
to check the set-up before processing, audible signals to remind operators to do variousthings However, signals to operators are not exactly mistake-proof; only mechanismsthat prevent operations commencing until the right conditions have been set are proofagainst mistakes In cases where computer data-entry routines are used, mistake-proofingcan be built into the software such that the operator is prompted to make decisionsbefore irreversible actions are undertaken
In both cases the Design FMEA and Process FMEA should be analyzed to reveal tures that present a certain risk which can be contained by redesign withmistake-proofing features
fea-Initiating preventive action (4.14.3c)
The standard requires that the preventive action procedures include the initiation of ventive action and application of controls to ensure that it is effective
pre-This requirement addresses the implementation of the improvement plan prepared todeal with problems requiring preventive action The improvement plan should havedefined who is to take the preventive action and also the extent of the action to be taken:that is, only in the area where the trend was detected or over a much wider area In ini-tiating the action (see also Part 2 Chapter 1 under Personnel with organizationalfreedom) you need to carry it out in an organized manner, as follows:
l Notify those who will be affected by the change
l Take the action in accordance with the prescribed control procedures
l Monitor the effects of the action and collect the data
Trang 3l Analyze the data to determine whether the potential problem has been averted.
l Audit the implementation of the preventive action to verify that the agreed planshave been followed and conditions stabilized
Ensuring that information is submitted for management review (4.14.3d)The standard requires that the preventive action procedures confirm that the relevantinformation on actions taken including changes to procedures is submitted for manage-ment review
To ensure that information on your preventive actions is considered by the managementreview of the quality system, you should document the problem, the plan to solve it, theaction actually taken, and the result However, this section of the standard does notrequire you to produce any records of preventive action because no cross reference ismade to clause 4.16 You could therefore meet the requirement by ensuring that thosewith intimate knowledge of the preventive actions taken attend a management reviewmeeting and give a verbal report The changes to procedures, if any, will have been doc-umented because it is required by clause 4.14.1 and as you need to maintain records ofmanagement reviews, you will capture the information on preventive actions, and thusmeet the requirement If you operate a more complex quality system, verbal reports maynot be reliable You will therefore need to maintain records of preventive actions, as stat-
ed previously Your management review procedure, if you have one (see Part 2Chapter 1), should therefore make provision for collecting preventive action data
Trang 4Task list
1 Provide a means of collecting data from all verification operations.
2 Set up a procedure for recording customer complaints.
3 Provide a means for collecting design change and document change requests.
4 Provide (in the relevant procedures) requirements for recording and transmitting data pertinent to any subsequent corrective action analysis.
5 Provide, where relevant, a means of recording continuous processes to detect ation from the agreed standard.
devi-6 Establish performance indicators for each significant process.
7 Establish a method of recording the baseline performance for each of these processes.
8 Decide on who is to collect and analyze the data for determination of both tive and preventive actions.
correc-9 Decide on who is to investigate and propose corrective actions and preventive actions.
10 Prepare procedures for the analysis, investigation, and determination of the causes
of potential and actual deviation including the formation of diagnostic teams where necessary.
11 Provide tools and techniques to help investigators discover the causes of potential and actual deviation and determine their significance.
12 Provide for solutions to prevent the occurrence and recurrence of deviations to be proposed and agreed.
13 Provide forms for recording the agreed corrective and preventive action and target dates for completion.
14 Prepare procedures for reporting the results of the analyses to management.
15 Provide links between the corrective and preventive action reports and document, product, process, and organization changes.
16 Devise nonconformity reduction plans for common cause nonconformities.
17 Provide an escalation procedure for use when corrective and preventive action target dates have been exceeded or where detected problems require management action.
18 Provide procedures for managing corrective and preventive action programs where corrective action is required.
19 Provide visual evidence of required performance against actual performance at work locations.
20 Provide procedures for verifying that corrective and preventive actions achieve their objectives.
Trang 5Corrective and preventive action questionnaire
1 In what documents have you defined your corrective action and preventive action procedures?
2 How do you ensure that the corrective or preventive action taken is to a degree appropriate to the magnitude of the problem and commensurate to the risks encountered?
3 How do you implement and record changes resulting from corrective and tive action?
preven-4 How do you handle customer complaints?
5 How do you handle reports of product nonconformities?
6 How do you ensure that the cause of nonconforming product is investigated?
7 How do you eliminate the cause of nonconformities?
8 How do you ensure that corrective actions are taken and are effective?
9 What sources of information are used to detect, analyze, and eliminate potential causes of nonconformity?
10 How are problems requiring preventive action dealt with?
11 How is preventive action initiated?
12 What controls ensure the effectiveness of preventive actions?
13 How do you ensure that information on preventive action is submitted for ment review?
Trang 6manage-Dos and donts
J Do clarify the differences between remedial action, corrective action, and preventive action and apply them in a manner consistent with the definitions in ISO 8402.
L Dont take action before you have confirmed the presence of a problem.
L Dont announce you have confirmed that a problem exists before you have assessed its significance.
J Do check that the agreed corrective actions are being taken.
L Dont wait until the due date for the completion of the action to check if work has started.
J Do accept legitimate reasons for inaction and agree on new target dates.
L Dont display performance data unless those affected agree to it being displayed.
J Do look for potential causes of deviation dont wait until the alarm bells ring.
J Do concentrate on the vital few problems.
J Do monitor the trivial problems to detect a systematic deterioration in standards.
J Do enlist the support of the organization responsible for the problem to investigate the cause.
L Dont impose corrective actions on other organizations.
L Dont collect data for the sake of it always have a purpose.
J Do classify the problems into groups that have a common cause and special cause.
J Do attract managements attention to special cause problems and obtain ment to action.
commit-J Do train your investigators in diagnostic techniques.
L Dont persist with proposals for corrective action if management tells you they are not economic find more economic solutions.
J Do capture your organizations recovery plans into the corrective action system.
J Do impress on management that corrective action procedures exist to save resources.
J Do tell your complaining customers the action you have taken to resolve their lem.
prob-L Dont limit your corrective action system to products apply it to all operations including management decision making.
Trang 7Chapter 15
Handling, storage, packaging,
preservation, and delivery
Scope of requirements
These requirements are concerned with conformance control; that is, ensuring thatproducts remain conforming once they have been certified as conforming A more aptheading might have been Control of conforming product While handling, storage,preservation, and packaging appear in the quality loop (see ISO 9004) after inspectionand test, they are by no means only applicable at this stage They should appear in thequality loop at several stages because handling, storage, preservation, and packing can
be carried out following receipt of items from suppliers up to dispatch of end product tocustomers
They mainly apply to products as most of them are concerned with protecting the uct from damage and deterioration They apply to the end product and any items thateither form part of the product or are used to produce the product, including any tools,test equipment, and processing materials Although it is possible for some types of serv-ices to deteriorate, this use of the term preservation is covered by the process controland auditing requirements The only requirements that do apply to services are those foridentification, unless product is used in the delivery of a service If the servicing is done
prod-to a product, whether or not the product is owned by the supplier, protection of thatproduct is important
The requirements in element 4.15 are linked with other elements of the standard evenwhen there is no cross reference This relationship is illustrated in Figure 15.1
Trang 8Figure 15.1 Clause relationships with the handling, storage, packaging, preservation, and
delivery element
CUSTOMER
PRODUCTION ORDERS (4.3)
PRODUCTION SCHEDULE (4.15.6.3 & 4.15.6.4) INVENTORY (4.15.3.2)
RECEIVING INSPECTION (4.10.2) PURCHASING (4.6)
INCOMING GOODS STOCK ROOM (4.15.3) PACKING (4.15.4)
PACKING SPECIFICATIONS (4.4.5)
EVALUATE PACKAGING (4.4.7)
DELIVERY PERFORMANCE MONITORING (4.15.6.2)
SHIPMENT NOTIFICATION (4.15.6.5)
TRANSPORTATION (4.15.6.2)
FINISHED GOODS STOCK ROOM (4.15.3)
CUSTOMER SUPPLIED PRODUCT (4.7)
Trang 9Handling, storage, packaging, preservation,
and delivery procedures (4.15.1)
The standard requires the supplier to establish and maintain documented procedures forhandling, storage, packaging, preservation, and delivery of product
It is likely that you will need two types of procedure to cover these requirements, onegeneral and the other specific
You will need a means of identifying when handling, storage, packaging, preservation,and delivery procedures will be required and a method of preparing, identifying, pub-lishing, selecting, and controlling specific procedures covering these subjects Theseaspects should be covered by a general procedure
The identification of special handling, storage, packaging, preservation, and deliveryprovisions usually occurs in the design stage or the manufacturing or service planningphase, by assessing the risks to product quality during its manufacture, storage, move-ment, transportation, and installation Having identified that there is a risk to productquality you may need to prepare instructions for the handling, storage, packing, preser-vation, and delivery of particular items
In addition to issuing the procedures you will need to reference them in the appropriatework instructions in order that they are implemented when necessary In some cases itmay be more appropriate to include these provisions as an integral part of other proce-dures rather than have separate procedures Whatever the method, you will needtraceability from the identification of need to implementation of the provisions and fromthere to the records of achievement
Trang 10prod-HERE, THIS WAY UP, or the notices on batteries warning of acid In other cases you willneed to provide special containers or equipment There follows a short list of handlingprovisions which your procedures may need to address:
l Lifting equipment
l Pallets and containers
l Conveyors and stackers
l Design features for enabling handling of product
l Handling of electrostatic-sensitive devices
l Handling hazardous materials
l Handling fragile materials
Storage (4.15.3)
Use of designated storage areas (4.15.3.1)
The standard requires the supplier to use designated storage areas or stock rooms to vent damage or deterioration of product, pending use or delivery
pre-In order to preserve the quality of items that have passed receipt inspection they should
be transferred to stock rooms in which they are secure from damage and deterioration.You need secure storage areas for several reasons:
l For preventing personnel from entering the stock rooms and removing items out authorization
with-l For preventing items from losing their identity once the identity is lost it is oftendifficult, if not impossible, to restore complete identification without testing material
or other properties
l For preventing vermin damaging the stock
l For preventing climatic elements causing stock to deteriorate
While loss of product may not be considered a quality matter, it is if the product is tomer property or if it prevents you from meeting your customer requirements Delivery
Trang 11cus-on time is a quality characteristic of the service you provide to your customer and fore secure storage is essential.
there-To address these requirements you will need to identify and specify the storage areasthat have been established to protect product pending use or delivery Although it need
be only a brief specification, the requirements to be maintained by each storage areashould be specified, based on the type of product, the conditions required to preserveits quality, its location, and its environment Products that require storage at certain tem-peratures should be stored in areas that maintain such temperatures If the environment
in the area in which the room is located is either uncontrolled or at a significantly
high-er or lowhigh-er temphigh-erature, an environmentally controlled storage area will be required.All items have a limit beyond which deterioration may occur and therefore temperature,humidity, pressure, air quality, radiation, vibration, etc may need to be controlled Atsome stage, usually during design or manufacturing or service planning, the storage con-ditions need to be defined and displayed In many cases dry conditions at roomtemperature are all that is necessary but problems may occur when items requiring non-standard conditions are acquired You will need a means of ensuring that such items areafforded the necessary protection and your storage procedures need to address thisaspect It is for this reason that it is wiser to store items in their original packaging untilrequired for use If packets need to be opened, they should be sealed again before returninto storage
The standard requires you to designate storage areas This means that any area whereproduct is stored should have been designated for that purpose in order that the neces-sary controls can be employed If you store product in undesignated areas then there is
a chance that the necessary controls will not be applied
¢
¢ The quality system should make the right things happen by designand not by chance
You can identify the areas you have designated for storage of different types of product
in your quality manual or in a general storage control procedure You can then placenotices and markers around the area, if necessary, to indicate the boundaries where thecontrols apply
Receipt and dispatch from storage areas (4.15.3.1)
The standard requires the supplier to stipulate appropriate methods for authorizingreceipt and the dispatch to and from storage areas
Trang 12The content of storage areas should be known at all times in order that you can be fident that only that which is in storage areas is of a known condition Storage areascontaining conforming items should be separate from those containing nonconformingitems (see later under Preserving and segregating product) It follows therefore that when
an item is taken from a storage area the person taking it should be able to rely on it forming unless otherwise stated on the label If free access is given to add and removeitems in such areas, this confidence is lost If at any time the controls are relaxed, thewhole stock becomes suspect
con-There is often a need to supply items as free issue, as the loss of small value items is lessthan the cost of the controls to prevent such loss This practice can be adopted only ifthe quality of the items can be determined wholly by visual inspection by the personusing them
There are, however, issues other than quality which will govern the control of items instock Inventory control is a vital part of any business Stock ties up capital, so the lessstock that is held the more capital the firm has available to apply to producing output
A common solution, which satisfies both the inventory control and quality control, is toinstitute a stock requisition system Authorization of requisitions may be given by a per-sons supervisor or can be provided via a work order If someone has been authorized
to carry out a particular job, this should authorize the person to requisition the itemsneeded Again for inventory control reasons, you may wish to impose a limit on suchauthority requiring the person to seek higher authority for items above a certain value.The standard does not require stock records or inventory lists; however, without such asystem you cannot demonstrate you have control over the receipt and dispatch of itemsfrom storage areas The standard also does not require you to identify the location ofitems in stock, although without some reliable method of retrieving and accounting foritems you cannot demonstrate whether or not unauthorized items have entered the stor-age area
Stock condition assessments (4.15.3.1)
The standard requires the supplier to assess the condition of product in stock at priate intervals in order to detect deterioration
appro-Each time the storage controller retrieves an item for issue, there is an opportunity tocheck the condition of stock and this requirement should be written into the stock con-trol procedures However, some items may have a slow turnover in some storage areas,particularly maintenance storage areas where spares are held pending use There is also
a need to check periodically the overall condition of the stock for damage to the fabric
Trang 13of the building or room Rainwater may be leaking onto packaging and go undetecteduntil that item is removed for use.
Some items, such as electrolytic capacitors and two-part adhesives, may deterioratewhen dormant Others, such as rubber, adhesive tape, and chemicals, deteriorate withthe passage of time regardless of use These are often referred to as Shelf Life Items
or Limited Life Items Dormant electronic assemblies can deteriorate in storage andprovision should be made to retest equipment periodically or prior to release if in stor-age for more than one year
The assessment interval should depend on the type of building, the stock turnover, theenvironment in which the stock is located, and the number of people allowed access,and a period fixed and stated in your procedures The interval may vary from storagearea to storage area and should be reviewed and adjusted as appropriate following theresults of the assessment
on forecasts and estimates Some customers may protect you to some extent from tuations in demand by giving you advanced notification of their production and servicerequirements in order that your production schedule can be order driven Should anincrease in demand be necessary you should be given adequate warning in order thatyou can increase your inventory in advance of the need If adequate warning cannot begiven, you need suitable clauses in your contract to protect you against any unexpect-
fluc-ed fluctuations in demand that may cause you to fail to meet the delivery requirement.Inventory management is concerned with maintaining economic order quantities so thatyou order neither too much stock nor too little to meet your commitments The stocklevel is dependent upon what it costs both in capital and in space needed to maintainsuch levels Even if you employ a ship-to-line principle, you still need to determine theeconomic order quantities Some items have a higher value than others, thereby requir-ing a higher degree of control Use of the Pareto principle will probably reveal that 20%
Trang 14of inventory requires a higher degree of control to enable you to control 80% of theinventory costs.
It is not my purpose here to elaborate on inventory management as this is a ment function in its own right From the quality management viewpoint, however, thereare some factors that need to be considered
manage-An inventory management system should be established meaning set up on a nent basis to meet defined inventory policies and objectives approved by executivemanagement It should be documented meaning that there should be a description ofthe system, how it works, the assignment of responsibilities, the codification of best prac-tice, procedures, and instructions The system should be planned, organized, andcontrolled in order that it achieves its purpose A person should therefore be appointedwith responsibility for the inventory management system and the responsibilities of thosewho work the system should be defined and documented Records should be createdand maintained that show how order quantities have been calculated in order that thecalculations can be verified and repeated if necessary with new data The records shouldalso provide adequate data for continual improvement initiatives to be effective.Whether or not 100% on-time delivery is a requirement of your customers, you wontretain customers for long if you continually fail to meet their delivery requirements,regardless of the quality of the products you supply It is only in a niche market that youcan retain customers with a long waiting list for your products In competitive marketsyou need to exceed delivery expectations as well as product quality expectations toretain your market position
perma-In addition to establishing a documented inventory management system, you shouldoptimize turnover time meaning that the time a part goes through the system fromreceipt to use should be an optimum (The phrase turns over time equates to
turnover time.) To achieve optimum turnover you will need metrics for receiving andstorage times You should also assure stock rotation meaning that parts and materialsare used on a first-in-first-out (FIFO) basis The picking system will need to be date sen-sitive to operate FIFO
Controlling packing, packaging,
and marking processes (4.15.4.1)
The standard requires the supplier to control packing, packaging, and marking
process-es (including materials used) to the extent necprocess-essary to ensure conformance to specifiedrequirements
Trang 15Packing is an activity and packaging a material in this context A Packing Specificationdefines how an item should be packed, whereas a Packaging Specification details thenature of the package.
Control means setting standards, verifying conformance, and taking action on the ference The control of packaging and marking processes therefore means that you have
dif-to set packaging and marking standards or requirements, verify that these requirementsare being met by inspection, test, or analysis, and then remedy any deficiencies found.Packing, packaging, and marking processes need to be controlled in order that productremains in its original condition until required for use Packing processes should bedesigned to protect the product from damage and deterioration under the conditionsthat can be expected during storage and transportation
Control of packing and marking processes commences during the design phase or themanufacturing or service planning phase Packaging design should be governed by therequirements of clause 4.4, although if you only select existing designs of packagingthese requirements would not be applicable
You will need a means of identifying the packaging and marking requirements for ticular products and of identifying procedures for the design of suitable packagingincluding the preservation and marking requirements Depending on your business youmay need to devise packages for various storage and transportation conditions, preser-vation methods for various types of product, and marking requirements for types ofproduct associated with their destination Packages for export may require differentmarkings than those for the home market Those for certain countries may need to com-ply with particular laws
par-Systems for packaging (4.15.4.2)
Where applicable, preservation processes should require that the product be cleanedbefore being packed and preservative applied In other cases the product may need to
be stored in sealed containers in order to retard decay, corrosion, and/or contamination.Unless your customer has specified packaging requirements, there are several nationalstandards that can be used to select the appropriate packaging, marking, and preserva-tion requirements for your products Your procedures should make provision for theselection to be made by qualified personnel at the planning stage and for the require-ments thus selected to be specified in the packing instructions to ensure theirimplementation
Trang 16Packing can be classed as a special process since once the units are placed in the tainers and the containers sealed, the only way to subsequently verify the right units are
in the right containers is to break the seal and inspect the contents Your packing trols should therefore give you sufficient confidence concerning the contents ofcontainers without having to break the seals
con-Packing instructions should not only provide for protecting the product but also forincluding any accompanying documentation, such as:
l Assembly and installation instructions
l License and copyright notices
Systems for labeling (4.15.4.3)
The standard requires the supplier to have a system to ensure that all materials shippedare labeled according to customer requirements
Unless your customer has specified labeling requirements, markings should be appliedboth to primary and secondary packaging as well as to the product itself Markingsshould also be made with materials that will survive the conditions of storage and trans-portation Protection can be given to the markings while in storage and in transit but thiscannot be guaranteed while products are in use Markings applied to the product there-fore need to be resistant to cleaning processes both in the factory and in use
Trang 17Preserving and segregating product (4.15.5)
The standard requires the supplier to apply appropriate methods for preservation andsegregation of product when such product is under the suppliers control
Preserving product while the product is under your control may be addressed by yourhandling and packaging provisions, but in-process preservation may also be necessary
to protect finishes from deterioration during further processing Such measures need to
be specified in the work instructions for particular products For products that start todeteriorate when the packaging seal is broken, the suppliers responsibility extendsbeyond delivery to the point of use In such cases markings need to be applied to thecontainers to warn the consumers of the risks
The preservation processes should be designed to prolong the life of the product byinhibiting the effect of natural elements While the conditions in the factory can be meas-ured, those outside the factory can only be predicted Markings on packaging aretherefore essential to warn handlers of any dangers or precautions they must observe.Limited life items should be identified so as to indicate their useful shelf life The expirydate should be visible on the container and provisions should be made for such items
to be removed from stock when their indicated life has expired
Segregation is another important requirement and not only for nonconforming product
as specified in clause 4.13 Segregation is vital in many industries where products canonly be positively identified by their containers It is also important to prevent possiblemixing or exposure to adverse conditions or cross-contamination Examples where seg-regation makes sense are:
in place that will prevent product mixing
Trang 18Segregation may also be necessary in the packaging of products not only to prevent ible damage but electrical damage, as with electrostatic-sensitive devices Segregationmay be the only way of providing adequate product identity, as is the case with fasten-ers While a well-equipped laboratory can determine the difference between productsand materials the consumer needs a simple practical method of identification andlabeled packets are often a reliable and economic alternative.
vis-Delivery (4.15.6)
Protection of product after final inspection (4.15.6.1)
The standard requires the supplier to arrange for the protection of the quality of uct after final inspection and test and, where contractually specified, this protection shallextend to include delivery to destination
prod-The ISO 9001 requirements do not add anything that isnt covered in clause 4.15.4although the heading signals a quite different requirement The requirement that thesupplier arrange for protection of the product is different from the requirement in clause4.15.4 for the supplier to preserve the product but the main purpose of the packagingrequirements is to afford protection to the product Packaging does have another pur-pose that of easing handling and distribution These are economic and marketingconsiderations rather than quality considerations
It is quite common for companies to document their delivery practices covering ration for delivery, packaging, preservation, documentation checks, deliverydocumentation including, where applicable, export documents, transportation practices,etc ISO/TS 16949 supplements ISO 9001 in clause 4.15.6.2 by requiring all product ormaterial to be shipped in conformance with customer-specified requirements includingmode of transportation, routings, and containers It is therefore important that thesedetails be identified in the contract and, if they have been omitted, that you inform thecustomer of the arrangement you intend taking and seek customer approval The finalinspection requirements require you to complete the evidence of compliance with thespecified requirements, but only with respect to the finished product These require-ments also require you to complete all activities stated in the procedures or quality planbefore product is dispatched and (through the supplementary requirement) for no prod-uct to be dispatched until all the relevant specified requirements have been compliedwith
prepa-Sometimes delivery is made electronically using a modem and telephone line Theproduct may be a software package, a document stored in electronic form, or a facsim-ile Protection of the product is still required but takes a different form You need toprotect the product against loss and corruption during transmission
Trang 19After implementing all the requirements of ISO 9001 you should be able to certify witheach delivery that the products supplied have been designed and produced under con-ditions that meet ISO 9001 and tests and inspections carried out to confirm theirconformance with the contractual requirements The standard does not require such acertificate of conformance and while not essential it is a good way of giving your cus-tomers confidence You may have many product lines, some of which may not beregistered to ISO/TS 16949 A certificate provides the appropriate objective evidencethat the products supplied have been processed through the line registered toISO/TS 16949 Although many certificates are indeed worthless, by suitable regulationtheir quality can be assured.
Establishing delivery systems (4.15.6.2)
The standard requiressystems to be established to support 100% on-time deliveries tomeet customer production and service requirements
To guarantee shipment on time, you either need to maintain an adequate inventory offinished goods for shipment on demand or utilize only predictable processes and obtainsufficient advanced order information from your customer When you examine some ofthe requirements in ISO/TS 16949, you may be tempted to question how you can con-tinually improve performance, reduce costs, and minimize space, material travel,equipment downtime, process variation, etc and meet 100% on-time shipments Youcant, unless you have a partnership with your customer in which there is mutual assis-tance to meet common objectives Without sufficient lead time on orders you will beunlikely to meet the target However, the standard does acknowledge that you may notalways be successful There will be matters outside your control and matters over whichyou need complete control It is the latter that you can do something about and take cor-rective action should the target not be achieved
Firstly, you need to estimate the production cycle time during the production trial runs
in the product and process validation phase An assessment of the PFMEA shouldenable you to identify the risk areas and build in appropriate contingencies An assess-ment of your subcontractors previous delivery performance will also enable you topredict their future performance There are, however, many factors not featured in thetechnical assessment that may jeopardize shipment and this is where the quality system
is most beneficial Internal audits and management reviews will highlight activities thatpresent unacceptable risk to achieving shipment targets However, the primary source ofinformation will arise in the regular meetings of the cross-functional teams and byaddressing potential problems preventive action can be taken to minimize delivery prob-lems
Trang 20Monitoring lead-time requirements (4.15.6.2)
The standard requires suppliers to monitor adherence to established lead-time ments
require-One of the factors requiring improvement is service and this can be construed to includetiming This can relate not only to delivery timing but also reduction in lead time Whennew processes become stabilized over long periods and the frequency of improvementreduces as more and more problems are resolved, you will be able to reduce lead time
Monitoring performance to customer delivery requirements (4.15.6.2)
The standard requires suppliers to monitor performance to the customer deliveryrequirements with corrective actions taken as appropriate
Your planning and delivery procedures need to record estimated and actual deliverydates and the data collected and analyzed through a delivery performance monitoringprocedure When targets are not met you should investigate the cause under the cor-rective action procedures and formulate corrective action plans Where the cause isfound to be a failure of the customer to supply some vital information or equipment, itwould be prudent not to wait for the periodic analysis but to react promptly
Records of premium freight (4.15.6.2)
The standard requires records of supplier responsible premium freight to be maintained.Premium freight was addressed briefly in Part 2 Chapter 3 under Contract review, as it
is at the contract negotiation stage that the criteria will be established as to what is mium freight If you fail to make delivery by the planned means (the means agreed inthe contract) you may have no alternative but to choose a faster way of getting the ship-ment to its intended destination This may result in additional cost It is this cost that thecustomer wishes you to monitor and record
pre-Production scheduling (4.15.6.3)
The standard requires appropriate scheduling to meet customer requirements that issupported by an information system that permits access to production information at thekey stages of the process and is order driven