Questions on MPICS3719

1. Pg. 9 of 34 under Verification, bullet point 3what does Make sure board has good print definition before loading boards into CP. Mean? A: We verify printed boards with a visual inspection process and make sure there isnt any solder paste bridging, skips or misalignment. 2. Pg. 10 of 34, under Verification, bullet point 2 (and all other places this statement occurs) states Check all components for polarity, missing and wrong part placement. Where are the polarity requirements identified for the operators? A: In general polarity is identified by Pick & Place program that is made from supplied CAD data. Verification is done during First Article. 3. Pg. 10 of 34 under Work Content, bullet point 2, is illustrated on Top Side CAD a correct statement, since this is SMT Bottom Side? A: It has been corrected. 4. Pg. 10 of 34 under Work Content, bullet point 4 (and all other affected places this statement occurs), states Wash boards within 4-8 hoursis there variable data documented to verify this? A: This is an internal goal. Boards can stay longer than 4-8 hours without wash. We can verify by using our Shop Floor Data System. 5. Pg. 10 of 34 under TQC, bullet point 1 (and all other affected places this statement occurs) states Inspectors are responsible for inspecting PCAs based on IPC-610 Current Rev or per customer specification, if different. How does inspector know which document to use? A: Current Revision IPC Documents are provided to QCs as part of their training. 6. Pg. 10 of 34 under TQC bullet point 5 (and all other affected places this statement occurs), we dont want stamps sometime and stickers other timescan we change note to just stamps? A: The sticker will be removed. We will only use stamps. 7. Pg. 11 of 34 under Work Content bullet point 6 states Stamp to be clear and legible and located on bottom side of the PCB. Bullet point 7 states QC Inspection Stamp/Sticker: The stamp/sticker can be placed near the Serial No. Label. The stamp/sticker should be in an area without visible traces. I believe the serial number label is on the top side of the board, contradicting the bottom side requirement? A: S/N is used as part of ID not to indicate process step completion. The MPI comment has been changed.

8. Pg. 12 and 13, 14 of 34 under Work Content, bullet point 2, 1 and 1respectively, I know its a little nitpicking but can the arrows (in the note and under the picture) be the same color? A: It has been corrected 9. Pg. 15 of 34, under Work Content, bullet point 5, to be 100% inspected thru X-Ray after assembly and report to be givenwhat report and is a copy of it kept with the lot travelers or where is it kept? A: There will be no X-Ray needed for Maya Medical assemblies. We only X-Ray components with hidden leads. Comment Removed.

10. Pg. 16 of 34 under Work Content, bullet point 2 reads: After a Pass test, place stamp on a clear or designated area of the board. We should not give operators/inspectors options of where to stamp. They s/b defined. A: This was the instruction given in the Component Specification Document. QC Inspection Stamp/Sticker: The stamp/sticker can be placed near the Serial No. Label. The stamp/sticker should be in an area without visible traces. But there is not much room on the top side next to the label, will it be okay to place the stamps on the bottom side as shown in picture below?

11. Pg. 28 of 34 under Work Content bullet point 4, Make sure to use correct solder paste and flux (LEAD FREE PROCESS)shouldnt this note be moved to Pg. 29? Pg. 28 talks about loading the components. Pg. 29 is where the information concerning the type of solder paste and flux are located. Also is the callout above highlighted in Yellow correct? Are we using solder paste? A: We do not use solder paste it should be solder core. Comment corrected.

12. Pg. 30 of 34 under Work Content, bullet point 4, Make sure to use correct solder paste and flux (LEAD FREE PROCESS)Where is the solder type and flux called outis it the same as called out for the Selective Wave Solder Bottom on Pg. 29? A: We do not use solder paste. Comment Removed. 13. Pg. 33 of 34 under Work Content, bullet 3, and deviation labels are placed on the board. Where, typically, is the placement location of a deviation label called out? A: Any available space on the board. 14. Pg. 33 0f 34, I dont see any type of Inspection Stamp or Sticker called out after the Final Quality Check is performed. Should there be? A: It will be added. 15. Pg. 34 of 34 under Work Content I do not see any of the packaging requirements called out in Section 9.0, 10.0 11.0 or 12.0 of CS3719. I realize that the present intent is not to ship any PCBAs, however shouldnt these requirements s/b in here in case the situation changes? See excerpt of CS3719 below:
9.0 PACKAGING: If components are to be shipped or stored follow these instructions 9.1.1 Supplier to package each assembly in an individual ESD protective bag, sealed with ESD tape and with a label containing the following information. 9.1.2 Customer Name 9.1.3 Customer Part Number and Revision 9.1.4 Maya/Covidien PO Number STORAGE: Stored PCBA(s) at ambient conditions SHIPPING: Supplier to ship the PCBAs in a shipping container that will prevent physical or ESD damage and/or contamination DOCUMENTATION: 12.1 Certificate of Conformance (C of C) are required for each lot. Information on the C of C should include: 12.1.1 Supplier Name 12.1.2 Part Number and Revision 12.1.3 PO Number 12.1.4 Quantity 12.1.5 Supplier Lot Number 12.1.6 Individual PCBA Serial Numbers

10.0 11.0

12.0

A: Packaging instructions have been added to the MPI. Notes: In the MPI, theres 5 (or 6 depending on the outcome of discussions on item 14 above) separate callouts for inspection stamps/stickers. Is there enough room on the location called out for them all to be there and be legible? A: Yes there is.