Understanding The ISO/TS 16949:2002 Standard 

8.3 Control of nonconforming product  

You shall: 

Identify and control nonconforming product to prevent its unintended use or delivery 

Have a documented procedure to define the controls and related responsibilities and authorities to deal with nonconforming product. Nonconforming product must be dealt with in one or more of the following ways: 

a)    take action to eliminate the nonconformity 

b)    authorize its use, release, acceptance (under concession) by a relevant authority or where applicable by the customer 

c)    take action to preclude its original intended use or application 

Maintain records of the nature of the nonconformity and any subsequent actions (and concessions obtained)

Verify corrected product to show conformity to requirements

When nonconforming product is detected after delivery or use has started, take action appropriate to the effects (or potential effects) of the nonconformity. 

8.3.1 Control of N/C product - Supplemental 

You shall classify unidentified or suspect product as nonconforming product 

8.3.2 Control of reworked product 

Rework instructions including re-inspection requirements shall be accessible & used by appropriate personnel  

8.3.3 Customer Information 

 Notify customers promptly if nonconforming product has been shipped 

8.3.4 Customer Waiver 

When your product or manufacturing process is different from that currently approved, then you shall obtain a customer concession or deviation permit prior to further processing. 

v Keep a record of expiry date & quantity authorized by each concession or permit 

v Revert back to compliance with the original or superceding specification, when the customer authorization expires 

v Properly identify each container of material shipped on an authorization. This also applies to purchased product 

v Approve any requests from your suppliers before submission to your customers 

Key Explanation Points and Tips: 

Þ      Nonconforming product is defined as product that does not conform to customer requirements; applicable regulatory requirements or your own organization requirements. The definition may also apply to nonconforming processes and services. Nonconformities may relate to suppliers and outsourced work; your own organizational activities or product shipped to customers. Also review specific nonconforming product requirements at OEM customer or IATF websites. 

Þ      The controls under clause focus on eliminating the nonconformity, but not the cause. Eliminating the cause is addressed under clause 8.5.2. Your documented procedure for nonconforming product must include controls and responsibilities to – identify; contain it,(i.e. prevent further processing or use); keep records of the nature and other details of the nonconformity; notify appropriate personnel (see clause 5.5.1.1) and customers, where appropriate; evaluate what disposition action needs to be taken; carry out timely disposition; determine policies for release for further processing or shipment to the customer; obtain customer concessions and deviation permits; rework and re-verification; waivers and approvals of supplier materials, etc. 

Þ      Product or material found with no identification or its quality status is not known, must be treated as nonconforming product and controlled by the above procedure. 

Þ      If you find that nonconforming product has been shipped, without a customer concession, notify the customer immediately and use your procedure, to effectively contain and resolve the situation to your customer’s satisfaction. Where required, use the customer prescribed form for recording and controlling nonconforming product. 

Þ      An authorization refers to written permission (number or code) to ship or manufacture nonconforming product. The permission is usually very specific about product, quantity and time frame during which nonconforming product can be shipped. The authorization number or code must identify each container shipped under the authorization. 

Þ      A concession authorization allows you to ship nonconforming product, under controlled conditions. A deviation authorization allows you to manufacture product different from the original specification, under controlled conditions. Also review specific waiver requirements at OEM customer or IATF websites. 

Þ      Ensure that all rework has evidence of re-inspection after the rework has been done and that the personnel doing the rework and re-inspection have been trained (keep records of training) and are using the rework instructions. 

Þ      All customer-oriented processes (see clause 4.1) must show the interaction with your process for nonconforming product. 

Þ      Performance indicators to measure the effectiveness of control of nonconforming product may include – reduction in cycle time to evaluate and dispose of nonconforming product; reduced errors in preventing unintended use or delivery; improved alternate use of nonconforming product and cost recovery; etc.