Automotive Quality Systems Handbook Episode 10 pptx

the end product. If you concentrate on the process using the results of the product verification, you will gradually reduce rework until all output product is of consistent quality. It will therefore be possible to reduce dependence on product inspection and test. The requirements in element 4.9 are linked with other elements of the standard even when there is no cross reference. This relationship is illustrated in Figure 9.2. Planning production, installation, and servicing processes (4.9.1.1) The standard requires that the supplier identifies and plans the production, installation, and servicing processes which directly affect quality . The planning of production, installation, and servicing processes requires three levels: l Identifying which processes are required to produce, install, and service the product l Designing, commissioning, and qualifying these processes for operational use l Routing the product through the appropriate qualified processes In order to identify the production processes required to produce a particular product you need a production requirement in the form of product specifications which define the features and characteristics of the product that are to be achieved. By studying these specifications you will be able to identify the processes required to turn raw materials and bought-out components into a finished product. With manufactured products the processes may include machining, welding, fabrication, assembly, forming, plating, painting, heat treatment, etc. The next stage is to design the processes that have been identified. In many cases, exist- ing processes may well satisfy the need but process approval may be required if the tolerance on product characteristics is much less than the currently demonstrated process capability. Process design is a subject outside the scope of ISO 9001 but is covered by clause 4.2.4.9 of ISO/TS 16949 and hence addressed in Part 2 Chapter 2. The plans that route an item through the various processes from raw material to finished product are often called route cards . You may need separate plans for each process and each part, with an overall plan that ensures the product goes through the right processes in the right sequence. The number of plans is usually determined by the manner in which the specifications are drawn up. You may have drawings for each part to be made or one drawing covering several parts. Process control 347 auto209.qxd 10/04/00 21:36 Page 347 For installation operations you will need an installation requirement and an installation plan. Similarly for any other process which represents the core for your business, you will need a requirement and a plan to achieve the requirement. The plan should detail the processes you need to implement in order to achieve the requirement. Unless products, processes, and facilities are developed in parallel, the product will be unlikely to reach the market when required. This requires product and process development to proceed simultaneously with facility development and hence the term simultaneous engineering or concurrent engineering has emerged to optimize the relationship between design and manufacturing functions. It is not a case of designing only those products for which facilities exist, but designing those products that will give you a competitive edge and laying down facilities that will enable you to fulfill that prom- ise. Ensuring that work is carried out under controlled conditions (4.9.1.1) The standard requires that the supplier ensures that the production, installation, and servicing processes are carried out under controlled conditions . To ensure that the processes are carried out under controlled conditions the production plans need to: l Identify the product in terms of the specification reference and its issue status. l Define the quantity required. l Define which section is to perform the work. l Define each stage of manufacture and assembly. l Provide for progress through the various processes to be recorded so that you know what stage the product has reached at any one time. l Define the special tools, processing equipment, jigs, fixtures, and other equipment required to produce the product. (General-purpose tools and equipment need not be specified because your staff should be trained to select the right tool for the job.) l Define the methods to be used to produce the product either directly or by reference to separate instructions. 348 Process control auto209.qxd 10/04/00 21:36 Page 348 l Define the environment to be maintained during production of the product in anything other than ambient conditions. l Define the process specifications and workmanship standards to be achieved. l Define the stages at which inspections and tests are to be performed. l Define any special handling, packaging, and marking requirements to be met. l Define any precautions to be observed to protect health and safety. These plans create a basis for ensuring that work is carried out under controlled conditions, but the staff, equipment, materials, processes, and documentation must be up to the task before work commences. A model production process is illustrated in Figure 9.3. The shaded boxes indicate interfaces external to the production process. The variables are too numerous to illustrate the intermediate steps. Installation plans need to cover similar material but in addition may include: l Site surveys l Site preparation l Transport and delivery of materials and equipment l Inspection of equipment entering the site l Storage of equipment awaiting installation l Storage of spares and consumables l Installation of equipment l Commissioning tests l Acceptance tests l On-site maintenance before hand-over l Hand-over to customer l Return of surplus and defective goods Process control 349 auto209.qxd 10/04/00 21:36 Page 349 350 Process control MARKETING DESIGN PRODUCTION REQUIREMENT PRODUCE PRODUCTION PLAN MAKE IN-HOUSE? GENERATE PIECE PARTS/UNITS MANUFACTURING PLANS PROCUREMENT SCHEDULE MANUFACTURE REQUISITION COMPONENTS/ MATERIALS MANUFACTURE PIECE PARTS/SUBASSEMBLIES INSPECTION CONFORMS? ASSEMBLE UNITS INSPECTION CONFORMS? UNIT TEST CONFORMS? FINAL INSPECTION PACKING No Yes INVENTORY CONTROL MEASURING DEVICE CONTROL Yes REQUISITION PARTS/ SUBASSEMBLIES Yes No Yes MEASURING DEVICE CONTROL INVENTORY CONTROL Yes Yes CONFORMS? No No Figure 9.3 Model production process auto209.qxd 10/07/00 16:47 Page 350 Process control 351 INVENTORY CONTROL SURVEY SITE ORDER PLANNING DESIGN INSTALLATION PLAN INSTALLATION PREPARE SITE DELIVER MATERIALS ENTRY INSPECTION CONFORMS? STORE MATERIALS INSTALLATION COMMISSIOING ACCEPTANCE CONFORMS? REMOVE SURPLUS NONCOMFORMITY CONTROL HANDOVER TO CUSTOMER Yes No Yes RETURN TO SOURCE Figure 9.4 Model installation process auto209.qxd 10/07/00 16:47 Page 351 A model installation process is illustrated in Figure 9.4 above. For servicing the plans need to define as appropriate: l The item to be serviced l The service to be performed l The responsibility for performing the work including the inspections and tests l The activities to be carried out l The process specifications and workmanship standards to be achieved l The procedures for disposing of any waste or defective product l The tools, equipment, and other aids to carry out the service and any inspections and tests l The manuals and other literature which specify how the tasks need to be performed l The consumable materials and spares required l The environment to be maintained if anything other than ambient l The handling and cleanliness requirements l The precautions to be observed to protect health and safety l The checks, inspections, tests, and adjustments to be made A model servicing process is illustrated in Figure 19.2. Documented procedures and job instructions (4.9.1.1 and 4.9.2) The standard requires controlled conditions to include documented procedures defining the manner of production, installation, and servicing where the absence of such instructions would adversely affect quality . The supplementary requirements also require job instructions for all employees having responsibilities for the operation of processes and for these job instructions to be accessible for use at the work station without disruption to the job. 352 Process control auto209.qxd 10/04/00 21:36 Page 352 ISO 9001 permits the absence of procedures where quality will not be adversely affect- ed. However, clause 4.9.2 of ISO/TS 16949 requires job instructions regardless of need. This apparent conflict is resolved by adopting the view that instructions command work to be done  procedures define the sequence of steps to execute the work to be done (see also Part 2 Chapter 2 under What are the differences between procedures and instructions?) The production plan referred to previously is a work instruction, as it instructs those to whom it applies to carry out certain tasks. Control procedures may include assembly procedures, plating procedures, painting procedures, maintenance procedures, etc. and differ from process specifications (see later) in that the process specification defines the results to be achieved in operating a process rather than how to run the process. In addition to the list of contents provided in ISO/TS 16949 clause 4.9.2, the documentation should define: l The qualifications required for the person carrying out the procedure (if any special qualifications are required) l The preparatory steps to be taken to prepare the product for processing l The preparatory steps to be taken to set up any equipment l The steps to be taken to process the product l The precautions to observe l The settings to record There are instructions for specific activities and instructions for specific individuals. Whether they are contractors or employees is not important  the same requirements apply. As each employee may perform different jobs, they may each have a different set of instructions that direct them to specific documents. Therefore it is unnecessary to combine all instructions into one document, although they could all be placed in the same binder for easy access. Any operation that relies on skills doesnt need a procedure. However, the operator will not be clairvoyant  you may need to provide procedures for straightforward tasks to convey special safety, handling, packaging, and recording requirements. You need to ensure that you dont make your processes so complex that bottlenecks arise when the slightest variation to plan occurs. The setting up of equipment, other than equipment typical of the industry, should be specified to ensure consistent results (see later in this chapter under Verification of job set-ups ). In fact any operation that requires tasks to be Process control 353 auto209.qxd 10/04/00 21:36 Page 353 carried out in a certain sequence to obtain consistent results should be specified in a procedure. By imposing formal controls you safeguard against informality which may prevent you from operating consistent, reliable, and predictable processes. The operators and their supervisors may know the tricks and tips for getting the equipment or the process to operate smoothly. You should discourage informal instructions as you cannot rely on them being used when those who know them are absent. If the tip or trick is important, encourage those who know them to bring them to the process owners attention so that permanent changes can be made to make the process run smoothly all the time. The standard also requires that the instructions be derived from appropriate sources, such as the quality plan, the control plan, and the product realization process, which means that all instructions should be traceable to one or more of these documents. They should form a set, so that there are no instructions used outside those that have been approved by the planning team. This is to ensure that no unauthorized practices are employed. Another important aspect to consider is the use of informal practices  practices known only to the particular operator. Process capability should be based on formal routines, otherwise repeatability cannot be assured when operators change. Accessibility of job instructions (4.9.2) The standard also requires job instructions to be accessible for use at the work station without disruption to the job. If you have a manufacturing process that relies on skill and training then instructions at the work station are unnecessary. For example, if fixing a tool in a tool holder on a lathe is a skill, learnt during basic training, you dont need to provide instructions at each work station where normal tool changes take place. However, if the alignment of the tool is critical and requires knowledge of a setting-up procedure, then obviously documented instructions are necessary. Even for basic skills you can still provide standard machinery data books which are accessible near to the work station, but a failure to do so should not be regarded as a noncompliance. There is merit in not providing basic text books to operators since the information is soon outdated and operators relying on such data instead of consulting the authorized data may inadvertently induce variation into the process. In interpreting this requirement you need to define what constitutes a work station. Is it a manufacturing cell where operations of the same type are performed or is it an indi- vidual machine? Next you need to define the meaning of accessible. Does it mean visible by the operator of the machine, in a cupboard near the machine, or on a shelf in the area? If a group of people work in an area equipped with several small machines of 354 Process control auto209.qxd 10/04/00 21:36 Page 354 the same type, set up to the same specification, then one set of instructions would probably suffice. Instructions for each machine may be necessary in areas where there are several machines of different types and set-up configuration. If the machines are huge and to access each requires a walk of some distance from your work station, instructions may be needed at each machine, regardless of set-up configuration. Use your common sense. Too many copies of the same document creates the chance that one may get missed when revisions occur. Single-page instructions, encapsulated in plastic to prolong their life, can be fixed on or close to the machine as a source of reference. ¢¢ Procedures are needed where consistency in results is vital. Suitable production, installation, and servicing equipment (4.9.1.1b) The standard requires controlled conditions to include the use of suitable production, installation, and servicing equipment . The production, installation, and servicing equipment should be selected during the planning process. In selecting such equipment you should determine whether it is capable of producing, maintaining, or handling conforming product in a consistent manner. You need to ensure that the equipment is capable of achieving the specified dimensions within the stated tolerances. Process capability studies can reveal deficiencies with equipment which are not immediately apparent from inspection of the first off (see below under Process capability and process control ). Suitable working environments (4.9.1.1b) The standard requires controlled conditions to include suitable working environment . The working environment may need to be controlled, not for the benefit of the staff but to achieve the required characteristics. To achieve high performance from electronic components, particle and chemical contamination has to be minimized during fabrication and assembly. For these and many other reasons, the production environment may need to be controlled. If these conditions apply you should: l Document the standards that are to be maintained. l Prohibit unauthorized personnel from entering the areas. Process control 355 auto209.qxd 10/04/00 21:36 Page 355 l Provide training for staff who are to work in such areas. l Provide alarm systems to warn of malfunctions in the environment. l Provide procedures for maintaining the equipment to these standards. l Maintain records of the conditions as a means of demonstrating that the standards are being achieved. ISO 9001 is not specific on what is meant by working environment. ISO 9001 only applies to product and factors that affect the product; therefore working environment means the environment in which work on product is carried out. If temperature, cleanliness, humidity, electromagnetic, and other environmental factors need to be controlled to ensure conforming product then their control provides a suitable working environment. An organization needs to provide safeguards for its people in order to comply with clause 4.1.7 on Impact on Society . Compliance with reference documents (4.9.1.1c) The standard requires controlled conditions to include compliance with reference standards/codes, quality plans, and/or documented procedures . The product specification should provide all necessary processing requirements that need to be implemented when carrying out particular processes; however, some of the requirements may need to be defined in separate process specifications which are invoked by reference. You may need to develop your own process specifications, but there are many national standards that may suit your needs and they come with the added benefit that they have been proven to work. The quality plan or procedures should not contain any further product requirements but may provide the verification methods to be employed, the precautions to be observed and the recording requirements to be met. You need to identify in your production plans each of these documents at the stage at which they should be applied, otherwise there is the possibility that they may be overlooked. 356 Process control auto209.qxd 10/04/00 21:36 Page 356 [...]... INSPECTION (4 .10. 3) CONTROL PLAN (4.2.4 .10) LABORATORY REQUIREMENTS (4 .10. 6) PROCESS CONTROL (4.9) FINAL INSPECTION (4 .10. 4) DELIVERY (4.15.6) Figure 10. 1 Clause relationships with the inspection and testing element INSPECTION AND TEST RECORDS (4 .10. 5) auto 210. qxd 10/ 04/00 21:36 Page 377 Inspection and testing 377 Inspection and test planning (4 .10. 1) Documenting inspection and test procedures (4 .10. 1.1)... part of the process and hence quality control, which for years was the name given to inspection departments, was misunderstood Inspection and test dont control quality Inspection and test merely measure the quality achieved and pass the results to the producer for remedial action auto 210. qxd 10/ 07/00 16:48 Page 376 376 Inspection and testing The requirements in element 4 .10 are linked with other elements... deals with inspection and test records, which are also covered in clause 4 .10. 5 The difference between these requirements is that clause 4 .10. 1 requires you to document the records to be established (in other words define) in the quality plan or procedures and clause 4 .10. 5 requires you to produce the records defined in the quality plan or procedures Your inspection and test procedures therefore need... standard required that you verify conformance in accordance with the quality plan, as it does in clause 4 .10. 3, it would give you the option of not specifying any measures at all in your quality plan for verifying conformance, but this has been covered by the requirements of 4 .10. 1 as already explained So what should you put into your quality plan or documented procedures on receipt inspection? The main... products This is one of the roles of the quality plan Within such a plan you should identify the verification stages during product development, production, installation, and servicing as applicable These stages will vary depending on the product, so your quality plan will be product, contract, or project specific (see Part 2 Chapter 2) There may auto 210. qxd 10/ 04/00 21:36 Page 378 378 Inspection and... other elements of the standard even when there is no cross reference This relationship is illustrated in Figure 10. 1 PRODUCT IDENTIFICATION (4.8) CUSTOMER SUPPLIED PRODUCT (4.7) QUALITY PLANNING (4.2.3.1) PURCHASE ORDER (4.6) RECEIVING INSPECTION (4 .10. 2) INSPECTION AND TEST REQUIREMENT (4 .10. 1) STORAGE (4.15.3) DOCUMENTATION CONTROL (4.5) INSPECTION AND TEST STATUS (4.12) NONCONFORMING PRODUCT CONTROL... be evaluated on a scale of measurement However, with inspection by attributes we sometimes use an acceptable quality level (AQL) that allows us to ship a certain percent defective in a large batch of product auto 210. qxd 10/ 04/00 21:36 Page 379 Inspection and testing 379 probably no more than 10 in 1,000 but to the automobile industry that is not good enough The standard imposes a strict requirement... Documenting inspections and tests (4 .10. 1.1) The standard requires that the required inspecting and testing and the records to be established be detailed in the quality plan or documented procedures The standard provides a choice as to whether you define the inspections and tests required in a quality plan or in documented procedures You may of course need to do both As the quality system is often designed... conduct experiments on the production line L Dont give control of the process to inspection J Do display process flowcharts in strategic areas to remind staff of the relationships auto 210. qxd 10/ 04/00 21:36 Page 375 Chapter 10 Inspection and testing Scope of requirements Inspection and test are methods of verifying that product complies with the specified requirements A more suitable term for this section... ensure that production processes which directly affect quality are identified, planned, and carried out under controlled conditions? 2 How do you ensure that installation processes which directly affect quality are identified, planned, and carried out under controlled conditions? 3 How do you ensure that servicing processes which directly affect quality are identified, planned, and carried out under . without disruption to the job. 352 Process control auto209.qxd 10/ 04/00 21:36 Page 352 ISO 9001 permits the absence of procedures where quality will not be adversely affect- ed. However, clause 4.9.2. entering the areas. Process control 355 auto209.qxd 10/ 04/00 21:36 Page 355 l Provide training for staff who are to work in such areas. l Provide alarm systems to warn of malfunctions in the environment. l. 10/ 04/00 21:36 Page 364 This requirement should not be necessary, as clause 4.9.1(b) addresses working environment but emphasizes that poor housekeeping and maintenance can affect product quality.