Transport of components off site for final assembly.

[regi_601]

My company is a contrct manufacturer of medical device instruments,. We manufacture the components at one facility that are transported off-site to another building for assembly (facilities are only about 0.3 miles apart). The components are packaged in plastic bags which are placed in bins and/or boxes. Most of the time an employee's truck or car is used. What I am concerned about is "chain of custdy" requirements and whether we should have a company vehicle with a lockable cover for transport. Is this a big deal to regulatory whether it is a company owned truck, or employee's vehicle used for transport. I say yes, it need to be a company owned vehicle, with a lockable cover, that is checked for possible contamination (odors, dirt, grease, etc.). Can someone give me the specific regulatory requirements for this?

 

[yodon]

I don't know that there's one particular requirement. For example, in the US, probably any of these could be cited:

• 820.70 (c) Environmental control. Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions.
• 820.70 (e) Contamination control. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.
• (maybe) 820.80
• (b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented
• 820.86 Acceptance status. Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing,...
• (maybe) 820.140 Handling. Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.

I think each of those has something parallel in 13485.

Bottom line is that it's your responsibility to make sure nothing you do will introduce a nonconformity or contamination.

 

[regi_601]

Thank you for the reply. I thought that section 820.7 was my basis for suggesting our company either place a locable cover on the company truck or buy something to pransport the components.