IATF 16949:2016 Clause 8.5.4.1 Preservation

These requirements are concerned with conformance control; that is, ensuring that products remain conforming once they have been certified as conforming. While handling, storage, preservation, and packaging appear in the quality loop after inspection and test, they are by no means only applicable at this stage. They 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 product 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 services 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.There are three distinct control requirements specified here.

Product identification – means knowing the identity of (yours or customer supplied) product from – incoming receipt of materials; raw material storage; use in production; work in progress; finished product storage; and delivery of product to the customer. Product identification can be controlled using physical and electronic methods.

Product status – means knowing the quality status (good or bad) of materials and product through each of the above stages. Product status can be controlled using physical and electronic methods.

Unique Product Identification For the automotive industry, unique product identification is mandatory for safety, regulatory and risk management reasons. This usually involves keeping detailed records for – material; equipment; personnel; processes; production; inspection and test details, etc., for individual products or production batches.

These records help to trouble-shoot product and process problems; resolve customer complaints; and enables continual improvement of product and process. In many instances, it also reduces cost, risk and use of resources by narrowing the problem down to a specific cause or instance. Depending on the product, the OEM may specify the degree of unique identification and traceability required. These controls may be included in your product realization processes through your product control plans; work instructions and other specific documentation. Examples of product identification and test status include physical tags, bar code labels linked to computer records; MRP systems tracking specific production runs/lots; automated production transfer processes, etc. Performance indicators (to measure the effectiveness of processes that control identification and traceability) may include – reduction in identification errors and omissions; product quality status errors and omissions; and traceability errors and omissions.  

Clause 8.5.4.1 Preservation

In addition to the requirements given in ISO 9001:2015 Clause 8.5.4 Preservation, clause 8.5.4.1 requires that the organization complies with preservation, packaging, shipping, and labeling requirements as provided by their customers. The organization are to use an inventory management system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out” (FIFO). The organization must ensure that obsolete product is controlled in a manner similar to that of nonconforming product. Preservation must include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. Preservation must apply to materials and components from external and/or internal providers from receipt through processing, including shipment and until delivery to/acceptance by the customer.   In order to detect deterioration, the organization shall assess at appropriate planned intervals the condition of product in stock, the place/type of storage container, and the storage environment.

Please click here for ISO 9001:2015 Clause 8.5.4 Preservation

Identification, handling, contamination control, packaging, storage, transmission or transportation, and protection Process

The standard requires the supplier to establish and maintain process for identification, handling, contamination control, packaging, storage, transmission or transportation, 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 process will be required and a method of preparing, identifying, publishing, selecting, and controlling specific process covering these subjects. These aspects should be covered by a general process. 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, movement, transportation, and installation. Having identified that there is a risk to product quality you may need to prepare instructions for the handling, storage, packing, preservation, and delivery of particular items. In addition to issuing the process 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 process rather than have separate process. 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

The organization are to provide methods and means of handling that prevent damage or deterioration. Handling provisions serve two purposes, both related to safety: protection of the product from the individual and protection of the individual handling the product. 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 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:

  • Lifting equipment a Pallets and containers
  • Conveyors and stackers
  • Design features for enabling handling of product
  • Handling of electrostatic-sensitive devices
  • Handling hazardous materials
  • Handling fragile materials

Storage

The organization must use designated storage areas or stock rooms to prevent 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:

  • For preventing personnel from entering the stock rooms and removing items without authorization.
  • 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.
  • For preventing vermin damaging the stock.
  • 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 customer property or if it prevents you from meeting your customer requirements. Delivery on time is a quality characteristic of the service you provide to your customer and therefore secure storage is essential. To address these requirements you will need to identify and specify the storage areas that 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 area should be specified, based on the type of product, the conditions required to preserve its quality, its location, and its environment. Products that require storage at certain temperatures 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 higher or lower temperature, 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. At some stage, usually during design or manufacturing or service planning, the storage conditions need to be defined and displayed. In many cases dry conditions at room temperature 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 are afforded the necessary protection and your storage procedures need to address this aspect. It is for this reason that it is wiser to store items in their original packaging until required for use. If packets need to be opened, they should be sealed again before return into storage. The standard requires you to designate storage areas. This means that any area where product is stored should have been designated for that purpose in order that the necessary controls can be employed. If you store product in undesignated areas then there is a chance that the necessary controls will not be applied. 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 place notices and markers around the area, if necessary, to indicate the boundaries where the controls apply.

The content of storage areas should be known at all times in order that you can be confident that only that which is in storage areas is of a known condition. Storage areas containing conforming items should be separate from those containing nonconforming items . It follows therefore that when an item is taken from a storage area the person taking it should be able to rely on it conforming unless otherwise stated on the label. If free access is given to add and remove items in such areas, this confidence is lost. If at any time the controls are relaxed, the whole stock becomes suspect. There is often a need to supply items as free issue, as the loss of small value items is less than the cost of the controls to prevent such loss. This practice can be adopted only if the quality of the items can be determined wholly by visual inspection by the person using them. There are, however, issues other than quality which will govern the control of items in stock. Inventory control is a vital part of any business. Stock ties up capital, so the less stock 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 to institute a stock requisition system. Authorization of requisitions may be given by a person’s 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 items needed. Again for inventory control reasons, you may wish to impose a limit on such authority 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 a system you cannot demonstrate you have control over the receipt and dispatch of items from storage areas. The standard also does not require you to identify the location of items in stock, although without some reliable method of retrieving and accounting for items you cannot demonstrate whether or not unauthorized items have entered the storage area.

Contamination control

The organization must assess the condition of product in stock at appropriate intervals in order to detect deterioration. Each time the storage controller retrieves an item for issue, there is an opportunity to check the condition of stock and this requirement should be written into the stock control process. 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 of the building or room. Rainwater may be leaking onto packaging and go undetected until that item is removed for use. Some items, such as electrolytic capacitors and two-part adhesives, may deteriorate when dormant. Others, such as rubber, adhesive tape, and chemicals, deteriorate with the 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 and provision should be made to retest equipment periodically or prior to release if in storage for more than one year. The assessment interval should depend on the type of building, the stock turnover, the environment 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 storage area to storage area and should be reviewed and adjusted as appropriate following the results of the assessment. Contamination can lead to various issues, such as reduced performance, increased wear and tear, and potential safety hazards. To mitigate these risks, automotive manufacturers implement various measures to control contamination at different stages of the production process. Here are some key areas where contamination control is crucial:

  1. Manufacturing Processes: Contamination can occur during the production of automotive components. Manufacturers use cleanrooms and controlled environments to minimize airborne particles, dust, and other contaminants during manufacturing processes like welding, painting, and assembly.
  2. Lubricants and Fluids: Proper management of lubricants, oils, and other fluids is essential to prevent contaminants from entering critical systems, such as engines and transmissions. Regular monitoring, filtering, and using high-quality fluids help maintain the performance and longevity of automotive components.
  3. Filtration: Automotive systems, such as engines and air conditioning, rely on filtration systems to prevent particles and pollutants from entering sensitive components. Regularly replacing and maintaining filters is crucial to ensure their effectiveness.
  4. Clean Handling and Packaging: During transportation and storage of automotive components, maintaining a clean environment and using appropriate packaging can prevent contamination from dust, moisture, or chemical exposure.
  5. Cleanroom Assembly: Some automotive manufacturers employ cleanroom assembly practices for sensitive components to minimize the risk of contamination during the assembly process.
  6. Supplier Management: Automotive companies work closely with suppliers to ensure the quality and cleanliness of the parts they receive. Regular audits and quality checks are conducted to verify compliance with contamination control standards.
  7. Employee Training: Proper training and education of employees on contamination control protocols are essential to prevent unintentional contamination during manufacturing and assembly processes.
  8. Environmental Control: Controlling the environment within the production facility, including temperature, humidity, and air quality, helps reduce the likelihood of contamination.
  9. Inspection and Testing: Regular inspection and testing of finished vehicles and components can help identify and address any potential contamination issues before they become significant problems.
  10. Continuous Improvement: Implementing a culture of continuous improvement allows automotive manufacturers to identify areas for enhancement in contamination control processes and technologies.

Overall, contamination control in the automotive industry is an ongoing and multi-faceted effort that involves coordination across different stages of production, adherence to best practices, and proactive monitoring and maintenance. By prioritizing contamination control, automotive manufacturers can uphold the quality and reliability of their products, ensuring customer satisfaction and safety.

Packing

The organization are tocontrol packing, packaging, and marking processes (including materials used ) to the extent necessary to ensure conformance to specified requirements. Packing is an activity and packaging a material in this context. A Packing Specification defines how an item should be packed, whereas a Packaging Specification details the nature of the package. Control means setting standards, verifying conformance, and taking action on the difference. The control of packaging and marking processes therefore means that you have to set packaging and marking standards or requirements, verify that these requirements are 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 product remains in its original condition until required for use. Packing processes should be designed to protect the product from damage and deterioration under the conditions that can be expected during storage and transportation. Control of packing and marking processes commences during the design phase or the manufacturing or service planning phase. You will need a means of identifying the packaging and marking requirements for particular products and of identifying procedures for the design of suitable packaging including the preservation and marking requirements. Depending on your business you may need to devise packages for various storage and transportation conditions, preservation methods for various types of product, and marking requirements for types of product associated with their destination. Packages for export may require different markings than those for the home market. Those for certain countries may need to comply with particular laws.

Where applicable, preservation processes should require that the product be cleaned before 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 national standards that can be used to select the appropriate packaging, marking, and preservation requirements for your products. Your procedures should make provision for the selection to be made by qualified personnel at the planning stage and for the requirements thus selected to be specified in the packing instructions to ensure their implementation. Packing can be classed as a special process since once the units are placed in the containers 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 controls should therefore give you sufficient confidence concerning the contents of containers without having to break the seals. Packing instructions should not only provide for protecting the product but also for including any accompanying documentation, such as:

  • Assembly and installation instructions
  • License and copyright notices
  • Certificates of conformity
  • Packing lists identifying the contents of the container
  • Export documents
  • Warranty cards

The packing instructions are likely to be one of the last instructions you provide and probably the last operation you will perform for a particular consignment. This also presents the last opportunity for you to make mistakes! They may be your last mistakes but they will be the first your customer sees. The error you made on component assembly probably won’t be found, but the slightest error in the packaging, the marking, or the enclosures will almost certainly be found; therefore this process needs careful control. It may not be considered so skilled a process but all the same it is vital to your image.

labeling
The standard requires the supplier to have a system to ensure that all materials shipped are labeled according to customer requirements. Unless your customer has specified labeling requirements, markings should be applied both to primary and secondary packaging as well as to the product itself. Markings should also be made with materials that will survive the conditions of storage and transportation. Protection can be given to the markings while in storage and in transit but this cannot be guaranteed while products are in use. Markings applied to the product therefore need to be resistant to cleaning processes both in the factory and in use.

Protection

The organization must apply appropriate methods for preservation and segregation of product when such product is under the organization’s control. Preserving product while the product is under your control may be addressed by your handling 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 to deteriorate when the packaging seal is broken, the organization’s responsibility extends beyond delivery to the point of use. In such cases markings need to be applied to the containers to warn the consumers of the risks. The preservation processes should be designed to prolong the life of the product by inhibiting the effect of natural elements. While the conditions in the factory can be measured, those outside the factory can only be predicted. Markings on packaging are therefore 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 expiry date 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 vital in many industries where products can only be positively identified by their containers. It is also important to prevent possible mixing or exposure to adverse conditions or cross-contamination. Examples where segregation makes sense are Toxic materials, Flammable materials, Limited life items and Explosives. Segregation is not only limited to the product but also to the containers and tools used with the product. Particles left in containers and on tools, no matter how small, can cause blemishes in paint and other finishes, as well as violate health and safety regulations. If these are such risks in your manufacturing process, procedures need to be put in place that will prevent product mixing. Segregation may also be necessary in the packaging of products not only to prevent visible damage but electrical damage, as with electrostatic—sensitive devices. Segregation may be the only way of providing adequate product identity, as is the case with fasteners. While a well-equipped laboratory can determine the difference between products and materials the consumer needs a simple practical method of identification and labeled packets are often a reliable and economic alternative.Ensuring the protection of materials in the automotive industry is crucial to maintain the quality, safety, and reliability of vehicles and their components. There are several key strategies and practices that manufacturers employ to achieve this goal:

  1. Material Selection: The first step in material protection is choosing appropriate materials that can withstand the demands of automotive applications. Engineers carefully select materials based on their mechanical properties, corrosion resistance, and durability. Choosing materials with protective coatings or additives can further enhance their resistance to environmental factors, such as moisture, chemicals, and UV radiation.
  2. Quality Control and Testing: Rigorous quality control measures are implemented throughout the manufacturing process to ensure that materials meet stringent industry standards. Various testing methods, including destructive and non-destructive testing, are employed to identify any defects or weaknesses in the materials. This helps prevent the use of substandard materials and minimizes the risk of material-related failures.
  3. Coatings and Treatments: Applying protective coatings and treatments to materials is a common practice in the automotive industry. For example, corrosion-resistant coatings are often used to protect metal components from rust and oxidation. Surface treatments, such as passivation or anodization, can also enhance material resistance to wear and environmental degradation.
  4. Sealing and Encapsulation: In critical areas, such as electronic components and wiring harnesses, sealing and encapsulation techniques are used to protect materials from moisture, dust, and other contaminants. Potting compounds and gaskets create barriers that shield sensitive components, reducing the risk of damage and malfunction.
  5. Environmental Testing: Materials used in the automotive industry are subject to various environmental stresses, including temperature fluctuations, humidity, and exposure to chemicals. Environmental testing simulates these conditions to evaluate how materials perform under real-world scenarios. This testing helps identify potential weaknesses and guides improvements in material selection and design.
  6. Proper Storage and Handling: Automotive materials should be stored and handled with care to prevent contamination and damage. This includes using appropriate packaging, storing materials in controlled environments, and following proper handling procedures to avoid scratching, bending, or other forms of material degradation.
  7. Collaborative Supplier Relationships: Building strong and collaborative relationships with suppliers is essential for material protection. Automotive manufacturers work closely with suppliers to ensure the quality and integrity of materials at every stage of the supply chain. Regular audits, inspections, and quality checks help maintain high standards throughout the process.
  8. Research and Innovation: Continuous research and innovation play a crucial role in improving material protection. Automotive companies invest in R&D to develop new materials and technologies that offer enhanced resistance to wear, corrosion, and environmental influences. This ongoing improvement helps future-proof vehicles and components against emerging challenges.

By employing these strategies and practices, automotive manufacturers can ensure the protection of materials, leading to the production of reliable, durable, and safe vehicles. Material protection is an integral part of the automotive industry’s commitment to delivering high-quality products that meet and exceed customer expectations.Regenerate

Transmission or transportation

The standard requires the organization to arrange for the protection of the quality of product after final inspection and test and, where contractually specified, this protection shall extend to include delivery to destination. Packaging does have another purpose — that of easing handling and distribution. These are economic and marketing considerations rather than quality considerations. It is quite common for companies to document their delivery practices covering preparation for delivery, packaging, preservation, documentation checks, delivery documentation including, where applicable, export documents, transportation practices, etc. All product or material are to be shipped in conformance with customer-specified requirements including mode of transportation, routings, and containers. It is therefore important that these details be identified in the contract and, if they have been omitted, that you inform the customer of the arrangement you intend taking and seek customer approval. The final inspection requirements require you to complete the evidence of compliance with the specified requirements, but only with respect to the finished product. These requirements also require you to complete all activities stated in the procedures or quality plan before product is dispatched and (through the supplementary requirement) for no product to be dispatched until all the relevant specified requirements have been complied with. Sometimes delivery is made electronically using a modem and telephone line. The product may be a software package, a document stored in electronic form, or a facsimile. Protection of the product is still required but takes a different form. You need to protect the product against loss and corruption during transmission. After implementing all the requirements you should be able to certify with each delivery that the products supplied have been designed and produced under conditions that meet tests and inspections carried out to confirm their conformance with the contractual requirements. Ensuring the protection of materials during transmission or transportation in the automotive industry is crucial to prevent damage, contamination, and other risks that could compromise the quality of the materials or components being transported. Here are some key measures to ensure material protection during transmission:

  1. Packaging and Crating: Proper packaging and crating are essential to safeguard materials during transportation. Materials should be securely packed in suitable containers that offer protection against impacts, moisture, dust, and other environmental factors. Padding, foam inserts, and strapping can be used to further secure the materials within the packaging.
  2. Handling and Loading: Training employees involved in material handling and loading is essential to prevent mishandling or improper loading that could lead to damage during transit. Using appropriate lifting equipment, following proper loading procedures, and ensuring that materials are adequately secured within the transportation vehicle are critical steps.
  3. Climate-Controlled Transport: If the materials are sensitive to temperature and humidity fluctuations, using climate-controlled transportation is vital. This prevents exposure to extreme conditions that could potentially damage the materials during transit.
  4. Shock and Vibration Protection: Transporting materials on rough roads or over long distances can subject them to shocks and vibrations. Using shock-absorbing materials, such as airbags or cushioning, can help protect materials from excessive impact and vibration.
  5. Sealing and Encapsulation: For sensitive materials, especially electronic components, using sealing and encapsulation techniques can provide an additional layer of protection against moisture, dust, and contaminants during transportation.
  6. Hazard Identification and Mitigation: Identify potential hazards during the transportation process and implement measures to mitigate risks. This may involve securing materials to prevent shifting, marking packages as fragile, and providing clear instructions for handling.
  7. Collaborative Partnerships: Work closely with transportation and logistics partners to ensure they understand the importance of material protection. Maintain open communication to address any concerns or issues that may arise during the transportation process.
  8. Monitoring and Tracking: Employ tracking systems and real-time monitoring to keep an eye on the transportation process. This allows for timely intervention in case of any deviations from the planned route or unexpected delays.
  9. Insurance Coverage: Consider obtaining appropriate insurance coverage for the materials being transported. This ensures that any potential loss or damage during transit is adequately covered.
  10. Post-Transport Inspection: Conduct thorough inspections of materials upon arrival at their destination to verify their condition. This allows for prompt identification of any damage that may have occurred during transit and facilitates timely resolution.

By implementing these measures, automotive companies can significantly reduce the risk of material damage and ensure the protection of materials during transmission or transportation. This, in turn, contributes to the overall quality and reliability of automotive components and vehicles delivered to customers.

Inventory Management System

The standard requires use of an inventory management system to optimize inventory turns over time and assure stock rotation. To enable you to achieve delivery requirements you may need adequate stocks of parts and materials to make the ordered products in the quantities required. In typical commercial situations, predicting the demand for your products is not easy -organizations tend to carry more inventory than needed to cope with unexpected demand. The possibility of an unexpected increase in demand leads to larger inventories as an out-of-stock situation may result in lost customer orders. Most companies have to rely on forecasts and estimates. Some customers may protect you to some extent from fluctuations in demand by giving you advanced notification of their production and service requirements in order that your production schedule can be “order driven”. Should an increase in demand be necessary you should be given adequate warning in order that you can increase your inventory in advance of the need. If adequate warning cannot be given, you need suitable clauses in your contract to protect you against any unexpected fluctuations in demand that may cause you to fail to meet the delivery requirement. Inventory management is concerned with maintaining economic order quantities so that you order neither too much stock nor too little to meet your commitments. The stock level is dependent upon what it costs both in capital and in space needed to maintain
such levels. Even if you employ a “ship-to-line” principle, you still need to determine the economic order quantities. Some items have a higher value than others, thereby requiring a higher degree of control. Use of the Pareto principle will probably reveal that 20% of inventory requires a higher degree of control to enable you to control 80% of the inventory costs. It is not my purpose here to elaborate on inventory management as this is a management function in its own right. From the quality management viewpoint, however, there are some factors that need to be considered. An inventory management system should be established – meaning set up on a permanent basis to meet defined inventory policies and objectives approved by executive management. It should be documented – meaning that there should be a description of the system, how it works, the assignment of responsibilities, the codification of best practice, procedures, and instructions. The system should be planned, organized, and controlled in order that it achieves its purpose. A person should therefore be appointed with responsibility for the inventory management system and the responsibilities of those who work the system should be defined and documented. Records should be created and maintained that show how order quantities have been calculated in order that the calculations can be verified and repeated if necessary with new data. The records should also provide adequate data for continual improvement initiatives to be effective. Whether or not 100% on—time delivery is a requirement of your customers, you won’t retain 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 you can retain customers with a long waiting list for your products. In competitive markets you need to exceed delivery expectations as well as product quality expectations to retain your market position. In addition to establishing a documented inventory management system, you should optimize turnover time — meaning that the time a part goes through the system from receipt 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 and storage times. You should also assure stock rotation — meaning that parts and materials are used on a first-in-first—out (FIFO) basis. The picking system will need to be date sensitive to operate FIFO.

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