Re: Frozen/Fixed Process Procedures - Requirements from our Customers
I wove the following into my 7.5 procedure. I also made work instruction for each of our own special processes.
This covers more than just frozen processes. This whole section (along with other stuff) will be part of section 7.5.2 in the new AS9100C
3.6. Special processes WI 07-05-24 Welding, WI 07-05-25 EDM, WI 07-05-23 Etching, WI 07-05-22 Hole making process GE-P11TF12, WI 07-05-26 Induction Heat Treat
3.6.1. Significant process definition: A significant process is a sequence of operations (special or ordinary) that if changed could affect design intent; might affect material structure, mechanical, chemical or electrical properties; and cannot normally be evaluated without destructive testing.
184.108.40.206. Significant processes are designated by customer requirements. Significant process is sometime referred to as: VSE Process, Fixed Process, Frozen Process, EDI 1306 Process, etc.
220.127.116.11. Validation (or qualification) and changes or variations to such a process are handled in accordance with each customer requirements.
18.104.22.168. A Significant process may or may not include Special operations/processes.
22.214.171.124. Quality Control is responsible for submittal of initial and final qualifying documentation (FAI) for significant processes to the customer, for approval.
126.96.36.199. After initial approval of the special process by the customer, the significant process section(s) is/are "frozen" as defined by the customer requirement.
188.8.131.52. The routing sheet shall state: "This Manufacturing plan contains significant process/operations that may require customer approval for changes. Refer to customer specification for change approval requirement."
184.108.40.206. Significant process approval documentation will be maintained in the First Article package for the individual part number.
3.6.2. Significant Operation definition: A single operation which modifies or changes the inherent physical, chemical, electrical or metallurgical properties of an item, or non-conventional methods which remove or deposit material on a item during or after fabrication which can not be fully evaluated by non-destructive means, or those used to maintain process control such as non-destructive testing. This type of process may require a demonstration of operator or equipment capability or proficiency and require special controls for monitoring per specification. Means for compliance are contained in individual specifications. Typical processes/ operations are listed in customer's approved lists.
220.127.116.11. Special operations typically require a detailed technical plan. The special operation results are typically analyzed by an independent 3rd party (laboratory) and evaluated or approved by the customer.
18.104.22.168. This special operation evaluation and approval can usually employ a representative coupon or sample of the special operation performed if sample analysis would destroy the part.
22.214.171.124. Validation (or qualification), changes or variations to a significant operation are handled in accordance with each customer requirements.
126.96.36.199. Special operation approval documentation will be maintained in the First Article package for the individual part number.
188.8.131.52. Quality engineering is responsible for submittal of initial and final qualifying documentation for special operations to the customer, for approval.
184.108.40.206. Manufacturing engineering and Quality engineering will assure that the manufacturing operation sheets for the special operations are stamped with "This Manufacturing plan contains significant process/operations that may require customer approval for changes. Refer to customer specification for change approval requirement."
220.127.116.11. Manufacturing & Quality engineering are responsible for designating the initial source for each special operation on the routing sheet and identifying the operation as special by placing an "S" in the appropriate block on the routing sheet next to the operation.
18.104.22.168. Manufacturing & Quality engineering, Production control and Quality control are responsible for assuring that only customer-approved sources are utilized for material and all significant operations.
22.214.171.124. The following list is a guide as to what may be considered special operations/process. Final establishment for each individual part or operation shall be done by taking into account function, geometry, location of the operation in the manufacturing process, material, etc
· Isostatic pressing
· Chemical cleaning
· Mechanical cleaning (blasting, barreling, etc.)
· Thermal spray
· Heat treatment and Surface hardening
· Shot Peening
· Laser machining
· Adhesive bonding
· Corrosion protection
· Grinding to final form and dimension
· Forming (tool inspection, lubrication, stress relieve, etc.)
· Cold forming (bending, straightening, etc. after final heat treatment, shot peening, welding, brazing, plaiting)
· Etching, Etch inspection
· Magnetic particle inspection
· Penetrant inspection
· Radiographic inspection
· Ultrasonic inspection
· Eddy current inspection
· Operation sequence (heat treatment, plating, shot peening, NDT, marking transfer, final inspection, etc.)
3.6.3. Changes to significant operations/processes, unless otherwise specified by the customer, dual sourcing of significant operations will be done whenever practical. After initial approval is granted, should it be desirable to change the significant process, source, sequence, or other requirements, customer approval will be obtained prior to initiating the change.
126.96.36.199. “THE COMPANY” is responsible for the performance and or verification of the qualification, validation and control of special processes, regardless if they are performed within the company or subcontracted.
188.8.131.52. The following special processes are performed at “TH COMPANY”.:
· Welding WI 07-05-24
· Electrical Discharge Machining (EDM) WI 07-05-25
· Etching, Etch inspection WI 07-05-23
· Induction heat treat WI 07-05-26