AS9100 Rev D - Traceability of Consumables

[Bakka323]

Good Afternoon,

We had some discussions regarding the effectiveness of our traceability within our manufacturing process. When parts are picked for assembly jobs, lot numbers are recorded on pick lists however, during the assembly process items such as LocTite and grease is not accounted for on the pick list. Should the traceability of material like LocTite be accounted for? (what about other consumables like nuts, bolts and washers?)

When referencing AS9100 Rev D, Sect 8.5.2, traceability is referenced to be on a requirement basis (per customer). For customers that do require lot traceability, do you account for items like Loctite?

Thanks for the help!

 

[BoardGuy]

To some extent you are driven by both customer requirements and known application and risks associated with application. LocTite, grease, nuts, bolts, and washers could all require lot traceability per the note found in 8.5.2 if the application is for flight or manned spaceflight.

The 2nd determination if you should maintain lot traceability would be the financial risk. If your supplier notified you that one lot of bolts supplied does not meet your specified requirement out of the 20 lots supplied this year could you afford to recall the full year’s production to meet a government mandated recall simply because you did not have traceability to the production run the bolt was used in?

[FONT=&quot]Not every requirements found is AS9100D is linked to just because the customer requires it, many requirements are based on the needs of your organization, known application and associated risks that must be mitigated or accepted.[/FONT]

 

[dsanabria]

We had some discussions regarding the effectiveness of our traceability within our manufacturing process. When parts are picked for assembly jobs, lot numbers are recorded on pick lists however, during the assembly process items such as LocTite and grease is not accounted for on the pick list. Should the traceability of material like LocTite be accounted for? (what about other consumables like nuts, bolts and washers?)

When referencing AS9100 Rev D, Sect 8.5.2, traceability is referenced to be on a requirement basis (per customer). For customers that do require lot traceability, do you account for items like Loctite?

First - this should be a discussion during contract review.

Second - what does your AS9102 report is asking for.

Base upon your answer - you should now what to do and your requirements.

Not knowing your customer or their requirement it would be difficult to provide a direct answer.

 

[Marc]

I agree. Traceability issues should be part of contract review and must include any traceability requirements required by applicable national and international standards and regulations.

 

[BoardGuy]

[FONT=&quot]Though everyone is guiding you to traceability is something that is determined by your customer you must remember that the standard also require you to determine (in addition to what the customer indicates) that you must look at regulatory requirements (FAA, FDA etc.) may require.[/FONT]

[FONT=&quot]1. Scope[/FONT]

[FONT=&quot]This International Standard specifies requirements for a quality management system when an organization: [/FONT]

[FONT=&quot]a. needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements[/FONT]

[FONT=&quot]4.2 Understanding the Needs and Expectations of Interested Parties [/FONT]

[FONT=&quot]Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements,[/FONT]

[FONT=&quot]4.4 Quality Management System and Its Processes[/FONT]

[FONT=&quot]The organization’s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements.[/FONT]

[FONT=&quot]8.2.2 Determining the Requirements for Products and Services[/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: [/FONT]

[FONT=&quot]a. the requirements for the products and services are defined, including: [/FONT]

[FONT=&quot]1. any applicable statutory and regulatory requirements; [/FONT]

[FONT=&quot]2. those considered necessary by the organization;[/FONT]

So you must also consider the tractability requirement that may be required by a regulation related to the industry serviced, not just if your customer tell you.