Traceability is the intended ability to trace historically the location, movement or usage an item or an activity by means of documented information retained (record). It can be a requirement for a group of processes or for a complete system. It is also the unique ability to track and verify the location of product or process, history of processing or inspection or usage of the unique item through an identification provided in   documented information retained.

Quality Management system

Clause 8.5.2  of ISO 9001: 2015 Quality management system, requires that the  organization must  adopt appropriate  means to clearly  identify process  outputs, as and when  it is essential for ensuring  the conformity of  outputs, services and products. Identification of inspection status, monitoring status, measurement status as well as test status is mandatory, throughout the operation for realizing services and products.

Documented information for Quality management system

Whenever the traceability is a requirement (a regulatory requirement, a customer requirement or an implied requirement), the organization must plan and control the specific identification of the process outputs. There is specific mandate to retain the documented information (record), as an enabler for traceability.

Traceability is a recommended practice in certain industries which employ special processes. For a certain manufacturing process, if the output may not  be adequately  verified through subsequent inspection, measuring or monitoring, and  the impact of  deficiencies will surface,  after the product is put to intended  use, such  process needs to be treated as  special process. In aerospace industry for example, (AS 9100:2009) these processes can be called “special processes”. Traceability and validation of processes are the additional requirements in special processes.

Unique identification is needed on output, to monitor and display inspection status of an output. This could be identification mark, a tag, job number, a color sticker on the item being manufactured.

During the manufacturing process, the organization must maintain linkage or connection between the output stage of the product as well as the measuring, monitoring or testing requirements as well as measuring resources used. In other words, the organization must provide for planning and control of identification of resources(gauges for example) and trace them  to verification and  monitoring status,  to   establish what monitoring was done  and the gauges used.

Risk based approach

Requirement of the traceability can be applied to processes based on risks identified and application of the outputs to critical requirements. The training and competence of manpower must ensure that the traceability and identification requirements are understood correctly and applied diligently. Organization must create awareness about the identification and traceability requirements.

Identification applies to output of a particular process, and it is to be retained till the status of the output changes. Documented info in case of traceability must be available for ten to fifteen years in some cases, for regulatory requirements.  In case of vehicles some batches may have to be recalled at later stage because of certain malfunction of some components.  Traceability records can help trace the supplier of the components. Batch numbers of medicines are also used to address complaints, through traceable records.

An ISO 9001 consultant can provide valuable guidance for building an effective Quality management system.

 

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