During the production process, companies often conduct the crucial activity of first-off part validation. The purpose is straightforward: to prevent sending potentially non-compliant batches to the customer by ensuring compliance. Therefore, it serves as an integral component of the production process release strategy.
Consequently, when defining and implementing this activity, it’s essential to understand the common pitfalls to avoid.
First-off part validation and its alignment with the IATF standard requirements
Before delving into the main topic, it’s important to review the relevant requirements outlined in the IATF standard for first-off part validation. The Control Plan section (8.5.1.1) details the potential implementation of this action under point b), marked as ‘applicable’ in the standard.
In automotive industry practice, every client typically expects the implementation of such validation. Furthermore, it’s crucial to note that the operations outlined in the Control Plan reflect in the PFMEA, particularly in the detection section.
The first-off part validation is categorized under reduction of occurrence in the Control Plan, rather than detection.
Additionally, it’s worth noting that in justified cases, the part validation certificate can be retained until the completion of a specific batch’s production.. This facilitates the verification of any degradation in production equipment during the production process, as per requirement 8.5.1.3 – Verification of job set-ups (point d), with further details on record retention outlined in point e).
First-off part validation and its re-check during customer audits
During my preparation for work as a supplier quality engineer, I had the opportunity to review various training materials. One particular aspect stood out to me: a video presentation demonstrating how a supplier’s quality engineer obtains a “witness of the first-off part” from production for dimensional verification in a measurement laboratory.
Previously, I hadn’t considered such an audit scenario within the production area. Now, I make sure to share this knowledge during the training sessions I conduct. This information is particularly crucial for:
– Customer quality engineers: They have the opportunity to verify the first-off part witness provided by the supplier.
– Supplier quality engineers (SQEs): It allows them to enhance their audit competencies
– Manufacturing process internal auditors. Even if we don’t include such information in the internal checklist, it’s beneficial to include this verification during visits to the production area.
Approval of the first-off part on the night shift
On the night shift, the approval of the first-off part is particularly crucial during the production process release. This is due to reduced staff and resources, which can impact the thoroughness of validation processes.
Ideally, the validation process should be conducted in two stages: first, certifying the correct settings of production process parameters, and second, carrying out geometric verification and other tests by the laboratory department.
However, since laboratory staff are often not available or have limited resources during the night shift, production faces two options. One option is to quarantine manufactured products until they can be approved. Very often it done by the quality department at the beginning of the first shift the next day.
Alternatively, the company could select a production employee to conduct tests during the night shift. However, we must consider two potential issues with this approach:
– Whether the selected employee has appropriate competencies and receives periodic training to refresh their knowledge.
– Whether the production employee will objectively conduct measurements and report any non-compliance according to the escalation procedure.
Summary
First-off part approval is a critical element in ensuring the production of compliant components. Proper planning and implementation are essential for its success. This includes strategies for implementation, visualization, release of process parameters, and control by a quality representative.
Careful planning and execution of these processes are necessary, with particular attention given to customer requirements.
Dariusz Kowalczyk
Bibliography:
1. IATF 16949:2016 Frequently Asked Questions (FAQs) – dated 18/09/2023
