Understanding The ISO/TS 16949:2002 Standard 

7.5.3 Identification and traceability  

You shall: 

- Where appropriate, identify product by suitable means throughout product realization  

- Identify the status of product with respect to monitoring and measurement requirements 

- Control and record the unique identification of the product, (where traceability is a requirement). 

Note:   Configuration management is a means for maintaining identification and traceability in some industry sectors. 

Note:   You cannot use location of product as an indicator of inspection and test status, unless inherently obvious such as material in an automated production transfer process. Alternatives are permitted if status is clearly identified, documented and achieves the designated purpose. 

7.5.3.1 Identification and Traceability – Supplemental 

The words “Where appropriate” in 7.5.3 does not apply to the automotive sector 

Key Explanation Points and Tips:

Þ      There are three distinct control requirements specified here.  

Þ      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.  

Þ      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.  

Þ      Unique Product Identification – is not a mandatory requirement under ISO 9001, unless contractually required by customers. For the automotive or aerospace or pharmaceutical 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. Review specific requirements for identification and traceability at OEM customer or IATF websites. 

Þ      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. 

Þ      While this clause does not call for a specific documented procedure, 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.  

Þ      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.  

7.5.4 Customer Property 

Exercise care of customer property while under your control or being used 

Identify, verify, protect, and safeguard where provided for use or inclusion in your product 

Report to your customer, if their property is lost, damaged, or becomes unsuitable for use. 

Keep records of your control of customer property 

Note :  Includes customer owned returnable packaging and can include intellectual property 

7.5.4.1 Customer owned production tooling 

Permanently mark customer owned tools, manufacturing & test equipment so that the ownership of each item can be visibly identified or determined. 

Key Explanation Points and Tips: 

Þ      Customer property may include material; production equipment; tooling; measuring and test equipment; facilities; transport vehicles; returnable packaging; intellectual property (drawings, specifications or proprietary information); product returned for servicing under warranty, product sent for outsourced work; etc. Review specific requirements for customer property at OEM customer or IATF websites. 

Þ      All customer property is exposed to the risk of being damaged, lost, misused; misplaced; stolen, become unsuitable or obsolete for use. You must establish controls for each of these risks. Notify the customer in writing if their property is lost, damaged or otherwise found to be unsuitable (perishable past its shelf life, e.g. paint) for use.  

Þ      Control to minimize the risks to customer property include - inventory management; preservation and storage; identification, status and traceability indicators; maintenance; notification; traffic flow; authorized use;  restricted access; etc. Marking customer property with a unique identification number that can be traced to a record that provides details of ownership is one of many acceptable controls. 

Þ      This clause requires records to be kept of customer property that is lost, damaged or otherwise found to be unsuitable for use. This implies tracking the storage and use of and quality status, of customer property. 

Þ      While this clause does not call for a specific documented procedure, these controls may be included in your product realization processes through your product control plans; work instructions and other specific documentation. Many of the controls needed for clause 7.5.3 Identification and traceability and clause 7.5.5 Preservation of product apply to customer property. The processes, controls and documentation for these other clauses could be expanded to include customer property. 

Þ      Performance indicators (to measure the effectiveness of processes that control customer property) may include - reduction in identification errors and omissions; loss due to damage or unsuitability; scrap; rejects; etc., as well as increased customer property turnover rates.  

7.5.5 Preservation of Product 

Preserve the conformity of product during internal processing and delivery to the intended  destination 

Preservation shall include identification, handling, packaging, storage, and protection. 

Preservation shall also apply to the constituent parts of the product. 

7.5.5.1 Storage & inventory 

Assess stock condition at appropriate planned intervals, in order to detect deterioration. 

Use a inventory management system to optimize inventory turns and assure stock rotation such as ‘first in first out’ (FIFO). 

Control obsolete stock in a manner similar to the control of nonconforming product

Key Explanation Points and Tips: 

Þ      All raw materials, work in progress; finished product; supplies; customer provided materials or product; product sent for outsourced work; etc, are subject to risk of being damaged, lost, misused; misplaced; stolen, become unsuitable (perishable) or obsolete (past shelf life) for use. This could occur during receipt, handling; storage; use in production; transportation to the customer; etc. 

Þ      Controls include – inventory cycle counts; stock rotation methods such as FIFO; just in time; tracking shelf life; MRP systems for tracking requirements and usage; special, controls for restricted access; handling and storage of hazardous materials, climate and  environment; identification, status and traceability indicators; maintenance procedures; bar codes; training; use of special equipment for handling; etc. Also review specific requirements for preservation and storage at OEM customer or IATF websites. 

Þ      While this clause does not call for a specific documented procedure, these controls may be included in your product realization processes through your product control plans; work instructions and other specific documentation. Many of the controls needed for clause 7.5.3 Identification and traceability apply to preservation of product.  

Þ      Performance indicators (to measure the effectiveness of processes that control preservation of product) may include - reduction in identification errors and omissions; rejects; waste; scrap; etc., and increase in inventory turnover and material/product availability; and product safety.