3. reliability/Design/or designee (Does not apply for spinal BU)
(Reliability Checklist)This section is to be signed by a BU representing this function
Yes
No
(To be completed by ONE of the following: Design/Quality/Reliability/ Matls. Eng. or designate)
Requires bench, animal or clinical tests? Related Report(s): (If applicable) __________________________________
Any change to materials, or manufacturing processes for materials used in the drug pathway (contacts drug) of the device?
Requires biomatrix update? Related Report: (If applicable) ________________________________________
Is any new or increased risks added to the device as a result of the change(s)? Related Report(s): (If applicable) ________________________________________
Does the change impact the safety or performance of the device? Describe: _________________________________
Does the change improve the product safety? Describe: _________________________________
Requires technical file documentation update? Related Report(s): (If applicable) _________________________________
Pumps/Catheters: Does change affect the drug fluid path? (For other than drug infusion components, answer is always “No”)
After completing this section, send to Business Unit Regulatory for completion of section 4.
(To be completed by QA representative at mfg site for all changes)
Yes No
Device History Record Affected?
Approval sections (1 - 5, as required) complete?
Are required approving functions correct?
Signatures from all Business Units Affected?
Requires Testing?
Ref. Report(s): ______________________________
Yes N/A
Change to product verifiable?
Authorized design/ performance change?
Process change qualified?
ESD Impact Considered?
EHS Impact Considered?
Matrix/ FMEA PFMEA updated, if necessary?
New equipment/tools qualified?
Did you check that all red-lined documents versions established on the Affected Documents table on this form, match the version of the documents that were checked-in in Documentum?