AS9100 Pitfalls To Avoid!
Observations from an Aerospace Auditor
As a training and certification consultant organization that provides both precertification implementation services, as well as post certification services, we find that clients do not always take advantage of opportunities for improvement. These opportunities, when taken, can save an organization time and money, not to mention a lot of frustration.
Below are some of the findings and comments from one of our senior aerospace auditors.
Although it is important to have an approved supplier list, typically through an ERP system, it is also important to have a robust process to qualify these suppliers. A brief survey from the supplier (220.127.116.11) is not sufficient to evaluate the supplier. It is important to have periodic review of delivery performance and product quality, as well as have good processes to measure both. Staff should be trained so they understand the oversight of external providers and their requirements to monitor sub-tier providers. Adding these reviews can benefit your company in the long run by eliminating repetitive issues with external providers and the added time wasted to deal with them.
Control of Nonconforming Outputs
It is important to retain documented information describing a product nonconforming condition, what action was taken to correct the condition, and who was authorized to make this determination. It is not sufficient simply to red tag the hardware and note rework or scrap. (8.7.2) You must render the scrap unusable and you should keep data that tells you where you scrap. You can address eliminating the costs involved through improvement activity based on this data.
There are two types of risks: Quality Management System risks and Operational risks. Clause 6.1 addresses risks and opportunities when planning for the quality management system. The scope of clause 8.1.1 explains risk associated to the processes related to the product. It is important to understand and employ both. Our findings show that companies are often strong in one or the other, but not both. Seemingly the most inexpensive way to control nonconformance is to take no action as if they never happened. However, this is not the case. Be preventive early and nothing will go wrong. Reducing risk at the beginning and eliminating wasted need for action later. Employees should have an understanding of risk, risk analysis, and risk assessment through training.
Monitoring and Measuring Resources (Calibrated Equipment)
Our findings show that companies do not record the unique identification number when calibrated equipment is used for acceptance of a product. While there is no direct wording in the standard to record that data, companies may have a huge gap in being able to meet the following requirement(s): the organization shall determine if the validity of previous measurement results have been adversely affected when measuring equipment is found to be unfit for its intended purpose and shall take appropriate action, as necessary. (18.104.22.168) Not only is it important to record the unique identification number when calibrated equipment is used for acceptance of a product, it is equally important to review the calibration data upon return from the calibration external provider. Many AS9100D customers flow down the requirements to record the unique ID.
It is important to understand when the need for corrective action is required for customer complaints, internal nonconformances, missed quality objectives, and external provider nonconformances. (10.2.1) Implementing a process to follow up on corrective actions is important. Note: this is a dilemma – the “need” for corrective action needs determination. Customers may require it, but if not, a correction could be enough if it is a one-off and no trend is noted.
If any of these observations are issues your organization is dealing with, we can help!
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