Control of Non-Conforming Products

Control of Non-Conforming Products

It’s amazing, how quickly people get used to bad quality: Brian Eno

We do work with the best of our capability and commitment but sometimes, some error happens. Majority of them are identified and controlled before usage but there are few which passes to the end-user. If those defects are related to safety or legal requirements, it can create trouble. The seriousness of the non-conformity depends upon its usage. If an electronic component fails in a mobile, it has limited impact but if the same electronic component fails to function in an Aeroplan/ICU, the damages are huge to life, property and credibility of that organization.

Whenever an organization observes any non-conformity of its product or service, based on its criticality, the organization should take appropriate action. In certain cases, the customer has to be notified about the defect but in many cases, it can be corrected internally.

As per ISO 9000: 2015, following are the related definitions.

• Nonconformity (Clause 3.6.9): Non-fulfilment of a requirement.
• Conformity (Clause 3.6.11): Fulfilment of a requirement.
• Output (Clause 3.7.5): Result of a process
• Inspection (Clause 3.11.7): Determination of conformity to specified requirements
• Corrective Action (Clause 3.12.2): Action to eliminate the cause of nonconformity and to prevent a recurrence.
• Correction (Clause 3.12.3): Action to eliminate a detected nonconformity
• Concession (Clause 3.12.5): Permission to use or release a product or service that does not conform to a specified requirement.

Some of the key IATF subscribing OEM’s have specific requirements related to Control of non-conforming outputs. They are

Daimler: MBST 13/18, section 5, paragraph 6

FCA, USA: SQN-A0469 Supplier Incident Management – NAFTA, SQN-A0489 Third Party Containment and Problem Resolution (3CPR),

Ford: Worldwide Engineering Release System (WERS)

As per ISO 9001 & IATF 16949 Clause 8.7, there are few specific requirements related to Control of non-conforming Products. Based on the risk analysis, Standard has proposed the following possible actions.

1. Correction: When an organization identifies that product/service specifications are not meeting, repair or rework can be done on the suspected product. Example: For the online sale of Mobile, if instead of Model A, Model B is packed and despatched to the customer, it can be replaced before it is delivered to the user or at user end too.
2. Segregation: Identification and removal of non-conforming products can be done either at the organization or at customer end. Example: In the Moulding process, if job set up components are mixed with good quality components, they can be segregated by 100% inspection.
3. Containment: When an organization identifies that bad quality product is shipped to the customer and it is still in transit or warehouse, the product can be stopped from further movement and identified properly for any further use. Containment can happen at organization/customer premises also. Example: Containing the plated component, shipped to the customer, when failed Salt Spray test report is received from the laboratory.
4. Return or Suspension: When a customer identifies non-conforming product at their end, it is rejected and returned. Example: In the flight, if non-vegetarian food is served instead of vegetarian food, it can be returned back so that pre-ordered food can be offered.
5. Customer Notification: Depending upon the agreement with the customer and criticality of the defect, the customer can be communicated accordingly. It can be followed with detailed documentation of the event like what happened, why happened, root cause, possible actions, supporting documents etc. Example: When a calibration of the gauge (used for verifying critical dimension at final inspection) was done and it is found to be out of calibration, there is a possibility that despatched product may not be meeting the specification. In such cases, the customer has to be notified.
6. Concession/Deviation: Not all type of defects is related to safety or legal requirements. There are many defects which are related to fit, function and visual. The organization can take permission prior to further processing whenever the product or manufacturing process is different from that which is currently approved. Following are the possible ways of deviation
   1. “use as is”: The defect may not affect the functionality.
   2. Repair of nonconforming product: So that it can be used sparingly.
   3. Customer approval: Take approval from the customer for use of subcomponent for a defined timeframe or quantity.
   4. Record: Organization has to maintain evidence of the expiration date or quantity authorized under concession so that it can be reviewed for its effectiveness. The documentation will include a description of the nonconformity, its analysis, possible action taken, type of concessions obtained and the authority who decided the action.
   5. Compliance to original or superseding specifications: Organization has to ensure that once concession timeframe/Quantity is over, they have to restart complying with the original approved specifications. Example: Due to COVID-19, recalibration of instruments is extended by 3 months but once the situation is normalized, the earlier approved calibration frequency has to be restored.
   6. Identification: Material shipped under concession shall be properly identified on each shipping container so that both organization and customer can track its performance for any feedback from end-user. Example: Components tested with uncalibrated instrument (due to COVID-19) can be identified for its result (from the user) by batch number/Invoice number/Date code etc.
   7. Purchased product: All the above requirements related to deviation is equally applicable to the supplier to the organization also. The organization shall approve any requests from suppliers before submission to the customer.
   8. Disposition: Organization has to prepare a process (procedure) to deal with NC product. The non-conforming product has to be scrapped but before that, it has to be rendered unusable. The NC product shall not be diverted to service or other use without prior customer approval like after-market. Example: Non-conforming Tyres can be cut into pieces or marked with permanent red colour before disposition.

Possible Challenges:

• How often organizations communicate to the customer when non-conformity product is shipped to them?
• How often customer reciprocate positively in case an organization communicates about the shipment of NC product?
• How effective is the identification and traceability of material despatched under the concession (both at organization and customer end)?
• How often internal concession is done by a competent authority?
• How often concessions are documented?
• How often customer approval is taken before the disposition of nonconforming product to the replacement market?

References:

ISO 9000: 2015

ISO 9001: 2015

ISO/TS 9002: 2016

IATF 16949: 2016

Sanctioned Interpretation: IATF

This is the 62nd article of this Quality Management series. Every weekend, you will find useful information that will make your Management System journey Productive. Please share it with your colleagues too.

Your genuine feedback and response are extremely valuable. Please suggest topics for the coming weeks.