The definition of nonconformity states that it is the nonfulfillment of specified requirements; therefore a nonconforming product is one that does not conform to the specified requirements. Specified requirements are either requirements prescribed by the customer and agreed by the organization in a contract for products or services, or are requirements prescribed by the organization which are perceived as satisfying a market need & statutory and regulatory requirements This requirements applies to products, processes, and services and not to activities, quality system elements, or procedures. Any product may be considers as non conforming product which does not :
- Satisfy the specified requirements
- Satisfy intended usage requirements
- Satisfy stated or implied needs
- Satisfy your own requirements
- Satisfy customer expectations
You should classify all failures to meet these requirements as non- conformities and then assign classification so as to treat each according to its merits.
Clause 220.127.116.11 Control of suspect product
The organization must ensure that product with unidentified or suspect status is classified and controlled as nonconforming product. The organization must ensure that all appropriate manufacturing personnel receive training for containment of suspect and nonconforming product.
The standard indicates that these requirements are to apply to product that is suspected of being nonconforming -which might be the case with a batch of product that has failed the sampling inspection. Only the samples checked are definitely nonconforming-the others in the batch are only suspected as being nonconforming. You should therefore look further than the product that has been found to be nonconforming and seek out other products which may possess the same characteristics as those found to be nonconforming. These other products may have already been released to customers. This latter situation can arise if you discover the measuring or processing equipment to be inaccurate or malfunctioning. Any product that has passed through that process since it was last confirmed as serviceable is now suspect. Seeking suspect product should also be a factor to be considered when determining corrective action. Another example of suspect product is when product is mishandled but shows no obvious signs of damage. This may arise when product is dropped or not handled in the stipulated clean conditions or in accordance with electrostatic safe-handling procedures. Suspect product should be treated in the same manner as nonconforming product and quarantined until dispositioned. However, until a nonconformity can be proven, the documentation of the nonconformity merely reveals the reason for the product being suspect.
Although the standard does not explicitly classify nonconformities, the practical application of nonconformity controls requires controls to be balanced with the severity Of the nonconformity. It is not necessary to seek concessions from a customer against requirements that have not been specified, or seek design authority approval for workmanship imperfections. The definition of the term defect , and the fact that there are many requirements other than those specified in a contract or needed to satisfy market needs, demands that it is sensible to classify nonconformities into three categories:
- Critical Nonconformity: a departure from the specified requirements which renders the product or service unfit for use
- Major Nonconformity: a departure from the specified requirements included in the contract or market specification
- Minor Nonconformity: a departure from the supplier’s requirements not included in the contract or market specification
it is crucial for the organization to classify and control products with an unidentified or suspect status as nonconforming. When there is uncertainty about the status of a product, treating it as nonconforming helps prevent potential risks and ensures that proper control measures are implemented to manage its disposition effectively. Products with an unidentified or suspect status may pose risks to quality, safety, or compliance. Treating them as nonconforming ensures that they are properly assessed and managed to avoid any adverse impact. Treating products with uncertain status as nonconforming prevents their accidental use or distribution, reducing the likelihood of customer complaints or safety incidents. Classifying products as nonconforming creates a clear record of their status, ensuring traceability and enabling accountability for managing the situation. Taking prompt action and controlling products with an unidentified status demonstrates the organization’s commitment to maintaining quality standards, which helps build customer confidence.
Segregation of nonconforming product
The standard requires the supplier to provide for the segregation of nonconforming product and that quarantine areas have visual identification. Segregating a nonconforming product (or separating good from bad) places it in an area with restricted access. Such areas are called quarantine areas. Products should remain in quarantine until disposal instructions have been issued. The area should be clearly marked and a register maintained of all items that enter and exit the area. Without a register you won’t be able to account for the items in the area, check whether any are missing, or track their movements. The quarantine store may be contained within another area, providing there is adequate separation that prevents mixing of conforming and nonconforming articles. Where items are too large to be moved into a quarantine area, measures should be taken to signal to others that the item is not available for use and this can be achieved by cordons or ﬂoor markings. With services the simplest method is to render the service unavailable or inaccessible.
Review of nonconforming product
The organization is to review nonconforming product in accordance with documented procedures and advises that it may be:
- Reworked to meet the specified requirements, or
- Accepted with or without repair by concession, or
- Regraded for alternative applications, or d) Rejected or scrapped.
If you choose to accept a nonconforming item as is without rework, repair, etc., you are in effect granting a concession or waiving the requirement only for that particular item. If the requirements cannot be achieved at all, this is not a situation for a concession but a case for a change in requirement. If you know in advance of producing the product or service that it will not conform with the requirements, you can then request a deviation from the requirements. This is often referred to as a production permit. Concessions apply after the product has been produced, production permits apply before it has been produced and both are requests that should be made to the acceptance authority for the product. In some cases products and services are offered in several models, types, or other designations but are basically of the same design. Those which meet the higher specification are graded as such and those which fail may meet a lower specification and can be regraded. The grading should be reﬂected in the product identity so that there is no confusion. The inclusion of the term rejected is not a disposition because all nonconforming items are initially rejected. Items may be rejected and then returned to their supplier for action but all other rejections should be subject to one of the other dispositions. Scrapping an item should not be taken lightly — it could be an item of high value. Scrapping may be an economical decision with low cost items, whereas the scrapping of high value items may require prior authorization as salvage action may provide a possibility of yielding spares for alternative applications. The list in the standard omits two other possibilities, those of modification and completion. A product that is nonconforming may be so due to errors in the specification and can be eliminated by a modification to the design. The product may meet the specified requirement but be unfit for use, in which case this is a major modification. Alternatively, the product may meet the supplier’s specifications but not meet the customer or market specified requirements; this calls for a minor modification. Some modifications may be necessary only for certain batches due to variations in material or component tolerances. Modifications may be necessary to overcome component obsolescence or changes in bought-in parts that were not covered by the procurement specification. Completion of product is different to rework as “rework” implies that something was carried out incorrectly whereas “returning product for completion” implies that something was not done at all. To meet this requirement your documented procedures should specify the authorities who make the disposition, where it is to be recorded, and what information should be provided in order that it can be implemented and verified as having been implemented. In order to implement these requirements your nonconformity control procedures should include the following actions:
- Specify how product should be scrapped or recycled, the forms to be used, the authorizations to be obtained.
- Specify the various repair procedures, how they should be produced, selected, and implemented.
- Specify how modifications should be defined, identified, and implemented.
- Specify how production permits (deviations) and concessions (waivers) should be requested, evaluated, and approved or rejected.
- Specify how product should be returned to its supplier, the forms to be completed, and any identification requirements in order that you can detect product on its return.
- Specify how regrading product is to be carried out, the product markings, prior authorization, and acceptance criteria.
When making the disposition your remedial action needs to address:
- Action on the nonconforming item to remove the nonconformity
- A search for other similar items which may be nonconforming (i.e. suspect product)
- Action to recall product containing suspect nonconforming product
If you need to recall product that is suspected as being defective you will need to devise a recall plan, specify responsibilities and time-scales, and put the plan into effect. Product recall is a remedial action not a corrective action, as it does not prevent a recurrence of the initial problem. An auditor would expect to find staff consulting the rework instructions when carrying out rework. However, information in documents can be memorized or become habit through familiarity with the process. Rework instructions are often unique to the non-conformity and therefore personnel cannot rely on prior knowledge. When deciding on repair or rework action, you may need to consider whether the result will be visible to the customer on the exterior of the product. Rework or repairs that may not be visible when a part is fitted into the final assembly might be visible when these same parts are sold as service spares. To prevent on-the-spot decisions being at variance each time, you could:
- Identify in the drawings, plans, etc. those products which are supplied for service applications: i.e. for servicing, maintenance, and repair.
- Provide the means for making rework invisible where there are cost savings over scrapping the item.
- Stipulate on the drawings etc. the approved rework techniques.
Use of nonconforming product
The standard requires that where required by the contract, the proposed use or repair of product which does not conform to specified requirements shall be reported for concession to the customer or customer’s representative. The supplementary requirement requires customers to be informed promptly in the event that nonconforming product is shipped. The IATF 16949 requirement define two situations: one where you know in advance that the product is nonconforming and you want permission for its shipment, the other where at the time of shipment you did not know it was nonconforming and only found out subsequently. The only cases where you need to request concession from your customer are when you have deviated from one of the customer requirements and cannot make the product conform. Even when you repair a product, providing it meets all of the customer requirements, there is generally no need to seek a concession from your customer. While it is generally believed that nonconformities indicate an out-of-control situation, providing you detect and rectify them before release of the product, you have qualify under control, and have no need to report nonconformities to your customer.
Training of personnel
Providing training to all appropriate manufacturing personnel for the containment of suspect and nonconforming product is essential for effective quality management and product control. Proper training ensures that employees understand the importance of handling nonconformities and are equipped with the knowledge and skills to take appropriate actions when dealing with suspect or nonconforming products. Training ensures that manufacturing personnel are familiar with the organization’s documented processes for identifying, segregating, and containing suspect and nonconforming products. This helps ensure consistency and adherence to established procedures. Trained personnel are more likely to detect suspect or nonconforming products early in the manufacturing process. Timely detection allows for quick containment and minimizes the chances of the products progressing further in the production line. Proper training helps employees understand the potential risks associated with suspect or nonconforming products. This knowledge enables them to take appropriate precautionary measures and prevent further issues.Training emphasizes the importance of segregating nonconforming products from conforming ones to prevent accidental mixing or use, which could lead to quality problems or safety hazards. Properly trained personnel can effectively manage suspect or nonconforming products, reducing the likelihood of delivering defective products to customers and thereby enhancing customer satisfaction. To ensure effective training for containment of suspect and nonconforming product, the organization should consider the following: The training should cover the identification of suspect or nonconforming products, the organization’s procedures for containment, the importance of segregation, and reporting mechanisms. Regular training sessions and refresher courses should be provided to keep manufacturing personnel up to date with the latest processes and requirements. Maintain records of the training sessions conducted and the attendance of employees. This documentation helps in tracking compliance and identifying any gaps in training coverage. Encourage feedback from manufacturing personnel regarding the training and containment processes. Use this feedback to make improvements and enhance the effectiveness of the training program. Consider providing cross-functional training to employees involved in different stages of the manufacturing process. This helps in fostering collaboration and a unified approach to containment. By investing in proper training, the organization can empower its manufacturing personnel to play an active role in managing nonconformities effectively. Training contributes to the overall quality culture within the organization and reinforces the commitment to delivering high-quality products while meeting customer requirements and industry standards.