Diagnosis of IATF 16949:2016 clause – 8.7.1.5 Control of repaired products

Posted on: November 4th, 2017  /  By:  /  Posted in: #QUALiTYViVA, Control of repaired products, IATF, IATF16949, ISO, Repair, Rework, Rework and Repair  /  Comment: 6

Clause 8.7.1.5 – Control of repaired products

The organization shall utilize risk analysis (such as FMEA) methodology to assess risk in the repair process prior to a decision to repair the product. The organization shall obtain approval from the customer before to commencing repair of the product. The organization shall have a documented process for repair confirmation in accordance with the control plan or other relevant documented information. Instruction for disassembly or repair, including re-inspection and traceability requirement, shall be accessible to and utilized by the appropriate personnel. The organization shall obtain a documented customer authorization for concession for the product to be repaired. The organization shall retain documented information on the disposition of repaired product including quantity, disposition, disposition date, and applicable traceability information.

DIAGNOSIS:

  • First, this clause is one of the 21 mandatory procedure in standard (For details please visit my article,   https://qualityviva.wordpress.com/2017/09/07/iatf-16949-2016-21-mandatory-procedure/)
  • Second most important point to be noted that, there are total six (6) “shall” word are used as compared to five(5) in rework clause.
Understanding meaning of Rework I always preferred to refer ISO9000:2015 to understand any definition or explanation of word w.r.t ISO. Here to know about “repair” we will see clause 3.12.9 in ISO9000:2015. Repair: Action on a nonconforming (3.6.9) product (3.7.6) or service (3.7.7) to make it acceptable for the intended use. Processing the product, in such a way, that assures it acceptable for the intended use. A successful repair of a non confirming product or service does not necessarily make the product or service confirm to the requirement.  Example of Repair: If in some part there is requirement of hole and the drilled hole is of higher diameter than required. This has been repaired by first fill the hole with welding and again drilled the hole of required dimension. Here it is to be check this kind of repair work is acceptable for intended use as one of the document specifically pointed for rework to be carried without use of welding. Meaning of clause 8.7.1.4 line by line: 1) The organization shall utilize risk analysis (such as FMEA) methodology to assess risk in the repair process prior to a decision to repair the product. The organization shall obtain approval from the customer before to commencing repair of the product. Explanation: Before going to rework any part risk analysis to be carried out, better by using FMEA methodology ,for details on FMEA please follow link http://www.ijeit.com/vol%202/Issue%208/IJEIT1412201302_07.pdf ). This shall be carried out prior to finalizing for repair and also approval from customer to be obtain for this repair work. Here it is noted that in case of rework ,approval for rework to be obtain only when required by customer 2) The organization shall have a documented process for repair confirmation in accordance with the control plan or other relevant documented information. Explanation: Line clearly explains that, for this clause 8.7.1.5 documented process mandatory. The document include confirmation regarding repair in line with mentioned in control plan or in other document, such as TDC , drawings and /or specification.  3) Instruction for disassembly or repair, including re-inspection and traceability requirement, shall be accessible to and utilized by the appropriate personnel. Explanation: Roles and responsibility of personal shall be documented w.r.t instruction for disassembly or repair, re- inspection after repair, its traceability. 4) The organization shall obtain a documented customer authorization for concession for the product to be repaired. Explanation: Whenever there is requirement for any repair, organization has to obtain a concession from the customer, such concession (s) shall be maintained appropriately as part of documented information.. 5) The organization shall retain documented information on the disposition of repaired product including quantity, disposition, disposition date, and applicable traceability information. Explanation: Here, it is suggested to make a format, which fulfills requirement of “shall retain documented information” which cover requirement of above point, no 5 and include: 1) Role and responsibility of personal, 2) Instruction for disassembly or rework, 3) Re- inspection after repair, 4) Traceability 5) Verification for availability of concession form customer for repair 6)Disposition of repair product 7) Quantity, and  8)Disposition date. Hope this diagnostic of clause will be helpful.