Automotive Quality Systems Handbook Episode 13 pdf

plished then you have not determined the steps needed to deal with any problems requiring preventive action and are therefore noncompliant with ISO 9001. The action taken during process monitoring (see Part 2 Chapter 9) can be considered preventive action when corrections are made to the process ahead of occurring non- conformities. Hence Statistical Process Control is a technique which serves nonconformity prevention as well as detection. The steps you need to take to deal with specific problems will vary depending on the nature of the problem. The part that can be proceduralized is the planning process for determining the preventive action needed. A typical process may be as follows: l Devise a strategy for eliminating the cause together with alternative strategies, their limitations and consequences. l Gain agreement on the strategy. l Prepare an improvement plan which if implemented would eliminate the potential problem 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 going ahead. 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. Some plans may be very simple and require no more than an instruction to implement an existing procedure. Others may be more involved and require additional resources. The improvement plan should be seen as defining a quality objective and hence if a major change in performance is necessary, should be part of your Improvement Plan, which was addressed in Part 2 Chapter 1. In this way you are seen to operate a coherent and coordinated improvement strategy rather than a random and unguided strategy. While those on the firing line are best equipped to notice the trends any preventive action should be coordinated in order that the companys 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 preventive action process . Corrective and preventive action 467 auto214.qxd 10/04/00 21:39 Page 467 Mistake-proofing is a means to prevent the manufacture or assembly of nonconforming product. All people make mistakes. Mistakes are inadvertent errors and arise through human 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 to remind 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 pos- sibility of incorrect assembly, operation, or handling is avoided. In such cases the requirements for mistake-proofing need to form part of the design input requirements for the part. 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 various things. However, signals to operators are not exactly mistake-proof; only mechanisms that prevent operations commencing until the right conditions have been set are proof against mistakes. In cases where computer data-entry routines are used, mistake-proofing can be built into the software such that the operator is prompted to make decisions before irreversible actions are undertaken. In both cases the Design FMEA and Process FMEA should be analyzed to reveal fea- tures that present a certain risk which can be contained by redesign with mistake-proofing features. Initiating preventive action (4.14.3c) The standard requires that the preventive action procedures include the initiation of pre- ventive action and application of controls to ensure that it is effective . This requirement addresses the implementation of the improvement plan prepared to deal with problems requiring preventive action. The improvement plan should have defined 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 organizational freedom ) 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. 468 Corrective and preventive action auto214.qxd 10/04/00 21:39 Page 468 l 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 plans have 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 relevant information 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 management review of the quality system, you should document the problem, the plan to solve it, the action actually taken, and the result. However, this section of the standard does not require you to produce any records of preventive action because no cross reference is made to clause 4.16. You could therefore meet the requirement by ensuring that those with intimate knowledge of the preventive actions taken attend a management review meeting 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 of management reviews, you will capture the information on preventive actions, and thus meet the requirement. If you operate a more complex quality system, verbal reports may not 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 2 Chapter 1), should therefore make provision for collecting preventive action data. Corrective and preventive action 469 auto214.qxd 10/04/00 21:39 Page 469 Task 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 devi- ation from the agreed standard. 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 correc- tive and preventive actions. 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. 470 Corrective and preventive action auto214.qxd 10/04/00 21:39 Page 470 Corrective 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 preven- tive action? 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 manage- ment review? Corrective and preventive action 471 auto214.qxd 10/04/00 21:39 Page 471 Dos and donts 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 Dont take action before you have confirmed the presence of a problem. L Dont 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 Dont 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 Dont display performance data unless those affected agree to it being displayed. J Do look for potential causes of deviation  dont 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 Dont impose corrective actions on other organizations. L Dont 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 managements attention to special cause problems and obtain commit- ment to action. J Do train your investigators in diagnostic techniques. L Dont persist with proposals for corrective action if management tells you they are not economic  find more economic solutions. J Do capture your organizations 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 prob- lem. L Dont limit your corrective action system to products  apply it to all operations including management decision making. 472 Corrective and preventive action auto214.qxd 10/04/00 21:39 Page 472 Chapter 15 Handling, storage, packaging, preservation, and delivery Scope of requirements These requirements are concerned with conformance control; that is, ensuring that products remain conforming once they have been certified as conforming. A more apt heading might have been Control of conforming product . While handling, storage, preservation, and packaging appear in the quality loop (see ISO 9004) after inspection and test, they are by no means only applicable at this stage. They should appear in the quality 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 to customers. They mainly apply to products as most of them are concerned with protecting the prod- uct from damage and deterioration. They apply to the end product and any items that either 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 control and auditing requirements. The only requirements that do apply to services are those for identification, unless product is used in the delivery of a service. If the servicing is done to a product, whether or not the product is owned by the supplier, protection of that product is important. The requirements in element 4.15 are linked with other elements of the standard even when there is no cross reference. This relationship is illustrated in Figure 15.1. auto215.qxd 10/04/00 21:40 Page 473 474 Handling, storage, packaging, preservation, and delivery Figure 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) CUSTOMER SUPPLIED PRODUCT (4.7) PRODUCT IDENTIFICATION (4.8) HANDLING (4.15.2) PACKAGING (4.15.4) PRESERVATION (4.15.5) 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) auto215.qxd 10/07/00 16:52 Page 474 Handling, storage, packaging, preservation, and delivery procedures (4.15.1) The standard requires the supplier to establish and maintain documented procedures for handling, storage, packaging, preservation, and delivery of product . It is likely that you will need two types of procedure to cover these requirements, one general 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. These aspects should be covered by a general procedure. The identification of special handling, storage, packaging, preservation, and delivery provisions usually occurs in the design stage or the manufacturing or service planning phase, by assessing the risks to product quality during its manufacture, storage, move- ment, transportation, and installation. Having identified that there is a risk to product quality 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 appropriate work instructions in order that they are implemented when necessary. In some cases it may 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 need traceability from the identification of need to implementation of the provisions and from there to the records of achievement. Handling (4.15.2) The standard requires the supplier to provide methods and means of handling that pre- vent damage or deterioration . Handling provisions serve two purposes, both related to safety: protection of the prod- uct from the individual and protection of the individual handling the product. By referring back to clause 4.15.1 it would appear that element 4.15 of the standard is only concerned with safety of the product and not the individual; however, the two cannot and should not be separated and handling procedures should address both aspects. Handling product can take various forms, depending on the hazard you are trying to prevent from happening. In some cases notices on the product will suffice, such as LIFT Handling, storage, packaging, preservation, and delivery 475 auto215.qxd 10/04/00 21:40 Page 475 HERE, THIS WAY UP, or the notices on batteries warning of acid. In other cases you will need to provide special containers or equipment. There follows a short list of handling provisions 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 pre- vent damage or deterioration of product, pending use or delivery . 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 with- out authorization. l For preventing items from losing their identity  once the identity is lost it is often difficult, 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 cus- tomer property or if it prevents you from meeting your customer requirements. Delivery 476 Handling, storage, packaging, preservation, and delivery auto215.qxd 10/04/00 21:40 Page 476 [...]... evidence of activities performed or results achieved A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g product quality record) or the effectiveness of the operation of a quality system element (e.g quality system record) If a quality record was intended to be any document generated or used by the quality system, the definition would surely have indicated... Figure 16.1 Types of quality records The standard requires that quality records be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system But what are quality records, you may ask? If we put all the references to clause 4.16 together we get a list of 20 quality records: auto216.qxd 10/07/00 16:52 Page 492 492 Control of quality records PROCEDURES... assessments l Performance analysis l Deviations and waivers l Contract change records l Quality cost data l External Quality Audit records It is advisable to identify all your quality records within your procedures This will avoid arguments on what is or is not a quality record, because once you have chosen to identify a record as a quality record you have invoked all the requirements that are addressed in this... to specified requirements auto216.qxd 10/04/00 21:40 Page 496 496 Control of quality records Collection of quality records The standard requires the supplier to establish and maintain documented procedures for the collection of quality records In order to demonstrate the achievement of quality and the effectiveness of the quality system, records will need to be gathered in from the locations where... evidence it should not be assumed that all such documents are quality records The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records There are several types of document used in a quality system and only some are classified as quality records As quality records are documents it might be assumed that the... it rules out any recorded information as being a quality record Regarding the effectiveness of the quality system, the very existence of a document is not evidence of effectiveness but it can be regarded as a record To be a quality record, the document would need to contain results of an examination into the effectiveness of the system Identification of quality records The standard requires the supplier... 10/04/00 21:40 Page 495 Control of quality records 495 Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16 Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system ISO 8402 states... procedures should define how you provide and prohibit access to the records Filing quality records The standard requires the supplier to establish and maintain documented procedures for the filing of quality records The requirement for filing quality records is linked to the indexing requirement You should know where to find your quality records in order that you can retrieve them when needed They will be... in the procedures Storage of quality records The standard requires the supplier to establish and maintain documented procedures for the storage of quality records and in addition requires quality records to be stored in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss auto216.qxd 10/04/00 21:40 Page 498 498 Control of quality records Linked to the... have specified in your quality system, your plans, procedures, specifications, etc., this requirement may well be viewed as the most onerous in the standard A pragmatic approach to take is to declare in your quality manual that the “specified requirements” are “specified customer requirements” Demonstrating the effective operation of the quality system The standard requires that quality records be maintained . certificates are indeed worthless, by suitable regulation their quality can be assured. Establishing delivery systems (4.15.6.2) The standard requires systems to be established to support 100% on-time deliveries. assessing the risks to product quality during its manufacture, storage, move- ment, transportation, and installation. Having identified that there is a risk to product quality you may need to prepare. applied. ¢¢ The quality system should make the right things happen by design and not by chance. You can identify the areas you have designated for storage of different types of product in your quality