Identification

Article addresses the issue of identification in standard ISO 9001. ISO 9001 is a quality management standard that outlines requirements for a quality management system. Identification and traceability are two important concepts within the context of ISO 9001.

Identification

Identification refers to the ability to identify the origin, location, and status of a product, process, or service. This can include identifying the source of raw materials, tracking the progress of a product through the manufacturing process, and identifying the location of finished goods. Identification helps ensure that products and processes are properly controlled and that any issues can be quickly traced back to their source.

Identification is the possibility of distinguishing the product with certain characteristics (signs) during the product realization process. Identification of the product is one of several requirements that an organization implementing and maintaining a quality management system must meet (in accordance with paragraph 7.5.3 of the PN-EN ISO 9001:2009 "Identification and traceability") - where identifying a product or service is needed, one should identify methods of identification and conduct records.

Traceability

Traceability refers to the ability to trace the history, application, or location of a product, process, or service. This can include tracking the movement of raw materials through the supply chain, tracking the progress of a product through the manufacturing process, and tracking the movement of finished goods through distribution. Traceability helps ensure that products and processes are properly controlled and that any issues can be quickly traced back to their source.

Apart from the identification, p. 7.5.3 of ISO 9001, defines the traceability - the ability to trace the history, application or location of which is the subject of consideration and it may concern: the origin of materials and parts, manufacturing and distribution history and location of the product after its delivery. If the client or the law requires the traceability of the product, the organization has a duty to supervise its unambiguous identification.

Practical Examples

In some sectors, identification and traceability are required by applicable law or contract. For example, in the case of pressure vessels, identification and traceability records are gathered for particular material at all stages of production. This allows to back-trace the origin of the final product to the input material.

Summary

Together, identification and traceability are important tools that help organizations meet the requirements of ISO 9001 by providing a clear understanding of the history, location, and status of products and processes. This information can be used to identify and correct any issues, improve quality, and ensure that products and processes meet the requirements of the standard.

Advantages of Identification

Identification is an important part of ISO 9001 as it helps to ensure the quality of products and services. There are several advantages associated with identification that make it an important part of ISO 9001. These advantages include:

• Quality Control - Identification helps to ensure that products and services meet the standards set forth by ISO 9001. By tracking every product and service, it is possible to identify any potential flaws or defects. This allows companies to take corrective action before they reach the customer.
• Cost Savings - Identification also helps to reduce costs associated with reworking or replacing defective products or services. By identifying potential problems early on, companies can avoid expensive and time-consuming rework. This can save companies money and time in the long run.
• Traceability - Identification also helps to ensure traceability of products and services. This means that companies are able to trace the origin and history of their products and services. This makes it easier to identify any potential issues and take corrective action as needed.

Overall, identification is an important part of ISO 9001. It helps to ensure the quality of products and services, reduce costs, and ensure traceability.

Limitations of Identification

Identification and traceability are two important concepts within the context of ISO 9001, however, there are certain limitations associated with them. These limitations include:

• The ability to identify and trace products, processes, and materials is limited by the information that is available. For example, if the only information available is a product code, it may be impossible to trace the product back to its origin.
• Identification and traceability can be difficult to implement in complex systems, where processes and materials are interrelated.
• The cost of implementing an identification and traceability system can be prohibitively expensive, particularly for small businesses.
• It can be difficult to ensure accuracy and consistency of identification and traceability information over time, as the system must be regularly updated to account for changes in products, processes, and materials.
• The complexity of the identification and traceability system can lead to errors if it is not properly managed.

Other approaches related to Identification

In relation to identification and traceability, there are a range of other approaches that can be employed to ensure effective quality management. These approaches include:

• Risk-based thinking: This is an approach which looks at the risks associated with processes and seeks to identify and address them in order to ensure process effectiveness.
• Process mapping: This is an approach which involves visually mapping out a process and its related activities. This can help to identify any potential points of failure or areas for improvement.
• Root cause analysis: This is an approach which looks at the underlying causes of errors or problems and seeks to address them.
• Documentation: Documenting processes and activities is important in order to ensure that processes are being followed and that any changes can be tracked over time.

Overall, there are a range of approaches which can be employed in order to ensure effective identification and traceability within a quality management system. These approaches include risk-based thinking, process mapping, root cause analysis and documentation. By employing these approaches, organizations can ensure that their processes and activities are compliant with ISO 9001 standards.

Identification — recommended articles

Quality control plan — HACCP system — Quality control — Quality assurance — 7 wastes of lean — Value stream mapping — Final inspection — Line balancing — Operational control

References

• Lee, S. F., Roberts, P., & Lau, W. S. (1999). Survey on ISO 9000 quality management system implementation in Hong Kong. Managerial Auditing Journal, 14(1/2), 79-88.

Author: Sławomir Wyszyński