The benefits of AS9100 registration are immense - the challenge lies in appropriately aligning your business processes to demonstrate conformity with the requirements of the standard, and subsequently maintaining the system. With more than 100 additional requirements beyond ISO 9001:2000, plus the normal customer and regulatory requirements, AS9100 has many aspects that need to be considered to ensure a smooth transition.
As a forerunner in the aerospace registration industry, QMI has conducted numerous AS9100 audits. Using data from these audits, QMI has analyzed 100 nonconformances (NCRs) recorded over a series of AS9100 audits conducted across North America. The results are interesting, and in many cases offer opportunities to learn from common industry weaknesses. The results of this study provide valuable information on areas that organizations should focus on when implementing an AS9100 system.
Of the 100 NCRs, 90 were classified as minors and 10 were majors. 48% were written against AS9100 aerospace specific clauses, which are identified in the standard by bold, italic print. This reveals that aerospace auditors, due to their industry experience, focus on these specific clauses. Organizations should look closely at their own management systems, with special emphasis on these areas, and close any gaps prior to undergoing an external assessment.
A breakdown of NCRs, by clause, reveals that the top five areas of nonconformity identified in this sample of AS9100 audits are as follows:
1) Internal Audits (8.2.2): 13 NCRs (2 major)
2) Control of Production Provision: (7.5.1) 11 NCRs
3) Corrective Action (8.5.2): 8 NCRs (2 major)
4) Control of Monitoring & Measuring Devices (7.6): 8 NCRs (2 majors)
5) Control of Nonconforming Product (8.3): 7 NCRs (1 major)
The two main issues relating to internal audits are the timely completion of actions to eliminate nonconformities, and adherence to the documented audit schedule. Other issues include not auditing all processes and lack of auditor training. Internal auditing is not an aerospace specific requirement - it is one of the basic, fundamental requirements of a quality management system.
The section on Control of Production Provision produced the second highest number on NCRs. This section contains 5 subsections, 26 aerospace specific requirements and 10 key requirements. Key requirements are designated by the aerospace industry as having higher importance, and they therefore have a higher impact on the scoring of audits. The main areas of nonconformity in this section related to the control of production process changes, accountability of product, evidence of manufacturing operations and tooling control. Organizations should review these requirements thoroughly to ensure that any gaps are closed prior to an audit.
The third area is Corrective Action, and the study indicated that there is room for improvement here. Based on discussions with people working in the aerospace industry, there appears to be a perception that some organizations within the supply chain do not fully understand the concept of root cause analysis, and that their corrective action processes may not be effective. The findings seem to support this perception, and revealed that organizations often failed to implement corrective actions as planned, did not conduct adequate root cause analysis, and did not verify effectiveness. Organizations need to take a hard look at their corrective action processes to ensure that they function properly, and are used to facilitate improvement.
Next in line was the section on Control of Monitoring and Measuring Devices. This requirement is the basis for the validity of an organizations measurement system. NCRs identified here related to quality critical instruments either not being calibrated, or past the due date for calibration and still being used. Without a sound calibration system, the integrity of any product going out the door is questionable. Organizations need to provide sufficient resources for calibration, or subcontract this activity out.
The Control of Nonconforming Product, like Control of Production Provision, has a significant number of aerospace specific and key requirements. This importance of this section cannot be over emphasized - there is no room for inadequate controls for nonconforming materials or product in the aerospace industry.
Almost half of the nonconformances raised during AS9100 audits in this study were in the five categories identified here. These areas jeopardize both the quality management system and the integrity of product, and need to be more effectively implemented, especially in an aerospace environment. Organizations pursuing AS9100 need to mistake-proof these areas and ensure their effectiveness in order to achieve and maintain AS9100 certification.