March 2018 Newsletter

Two-thirds of the EN 9100 transition period have now passed. However, the final versions of the EN 9100 standards have still not been published. The final version is currently expected to be published in the second half of the year, though it may not be released until 2019. This is still due to ongoing legal disputes over copyright between the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). Until then, certificates will be issued based on the English version of EN 9100:2016. In the meantime, the transition to the new standard is proceeding slowly but steadily. As of March 1, 306 of the approximately 900 EN 91XX-certified companies in Germany had fully completed the transition to the new revision. This corresponds to about 40%. However, the number of certification audits already conducted is likely to be 10–15% higher, as there is a lag of about 4–6 weeks between the transition audit and entry into the OASIS database.

Initial evaluations by the IAQG revealed shortcomings primarily in the realignment and completeness of the management review (Section 9.3). It appears that, in many cases, not all necessary requirements were taken into account. Other major areas of concern included the handling of counterfeit parts (Section 8.1.4), awareness (Section 7.3), and the management of opportunities and risks (Section 6.1). There are no known instances of serious incidents occurring at well-prepared facilities.

Small businesses, in particular, often struggle with knowledge management requirements. To achieve a result that is both useful and appropriate for the business and the auditor, all areas of operation should be reviewed for business-relevant knowledge. This knowledge should then be listed—for example, in an Excel file—separately by sales, development, purchasing, etc., and its storage location or security measures should be documented. Opportunities and risks must also be taken into account (e.g., knowledge monopolies held by individual employees). At the same time, not only the current state but also the target state, as well as existing or planned tools (e.g., intranet, Excel solution, training), should be documented. Subsequently, measures should be derived in accordance with the PDCA cycle.

There are quite a few auditors who insist that nonconforming components must be stored in a locked area to prevent, as EN 9100 puts it, “their unintended use.” However, a lock is not strictly necessary for this purpose—in principle, adequate part identification and storage in a designated area should be sufficient. Should such parts nevertheless be used, this can only be considered intentional use, e.g., due to a lack of staff qualification or deliberate intent. No qualified worker would unintentionally (!) remove the lockout tag from a defective part in a restricted area in order to reuse the part. This line of reasoning should be presented in the event of any disputes with the certification auditor.