Operations: not just for hospitals!

Continuing on with the AS9100D “shall series”…

8.0 OPERATION pt 1  

At 80 “shalls”, the Operation requirement has the most by far, which makes perfect sense since Operation covers everything in your organization from quoting through shipping. We won’t go through each and every one, as I would quickly lose your interest, but will highlight some of the most critical shalls in this section.

Plain English Translation

The organization shall plan, implement, and control the processes needed to meet the requirements for the products and services you produce. Is primarily the process you use to convert customer requirements (PO, drawings, CAD data, etc.) into something employees can build the product to (travelers, work orders, etc.)   

The organization shall plan, implement, and control a process for managing operational risks to the achievement of applicable requirements. This is typically addressed through things like contract review, pFMEAs and/or control plans, and advanced quality planning. Product safety and counterfeit prevention are now shalls, as well as configuration (rev) control. If your operation has design responsibility there are many shalls that control the product design and development process.

The organization shall ensure that externally provided processes, products, and services conform to requirements. This refers to control of your suppliers, including establishing criteria and process for qualification and ongoing performance management.

Control of Production and Service Provision
The organization shall implement production and service provision under controlled conditions. Again, controlled conditions refer to the traveler, work order, etc. and inspection/test of product, including the calibration system.

Contact me to see how I can help you develop your QMS Operation process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com