1. Quality Improvement Plan (QIP) Training Session
MPROC First Article Inspection
“To be the company most trusted to deliver excellence in products, processes, services, and relationships.”

2. Hello and welcome to the course!
Dennis Del Toro - Humacao,Team Leader
Rosana M. Ortiz – Villalba
Michelle L. Pérez – Villalba
Jacob Velázquez – Juncos
Francisco Torres – Juncos
Carlos Curet - Humacao

3. MPROC First Article Inspection QIP Training
Agenda
Agenda
New procedure and form for the Packaging First Article Inspection activities
MPR-PPC-WI MPROC First Article Inspection Procedure
MPR-PPC-FRM First Article Inspection Report

4. MPROC First Article Inspection
Applicable Business Sectors:
CRDM
Villalba
Juncos
Neuromodulation
Diabetes (Consumables, External Pumps, Sensors)
Spinal
Surgical Technologies

5. MPROC First Article Inspection – Key Changes Impact
Before
After
Benefit
Procedures for FAI:
Villalba – DOC (FAI)
Juncos – QSC.0008 (FAI/PRA)
Humacao – SQSC.0007 (FAI/PRA)
MPR-PPC-WI
Standardization
Lean
Forms for the FAI:
Villalba – FRM (FAI)
Juncos – FRM (FAI), FM (FAI)
Humacao – SFRM.0090(FAI)
MPR-PPC-FRM
Procedures Complexity
6 documents in existence related to FAI
One MPROC Simplified System
2 documents – 66% reduction on the amount of documents

6. MPROC First Article Inspection
Scope: (Packaging & Labeling)
The scope of those procedures applies to all MPROC Sites.
FAI – First Article Inspection will be performed for new End Items prior to product release for human use.
Purpose:
FAI - verify compliance and proper implementation of produced product to the appropriate packaging design, product labeling (product markings, package labels and instructions for use) and manufacturing requirements prior to product release for distribution.
Background / Why is Required:
QIP Tier II (Labeling) Task. It is required to harmonize the First Article Inspections among MPROC.

7. MPROC First Article Inspection - Definitions
PIN / End Item - Product Identification Number that uniquely identify each Medtronic product offering to avoid duplication of product identifiers.
Pack to Order (PTO) - Product configuration that is not configured for final shipment to the customer and is shipped to other Medtronic facilities for final packaging. Final packaging typically involves labeling and packaging depending upon market requirements and geography.
Equivalent - when differences between the configurations do not change the product’s functionality, reliability, regulatory acceptance, or the information presented to the customer.

8. MPROC First Article Inspection – Responsibilities
Role
Responsibility
Inspection Leader
Manufacturing, Product or Packaging Engineering (Technical Resource -Engineer or Technician) leads the execution of this inspection, assures inspection conclusion is justified by results and assures corrective actions are addressed.
Inspection Reviewer
Quality Engineering (Technical Resource - Engineer or Technician) assures inspection conclusion is justified by results and assures corrective actions are addressed. Note: Quality Engineering may lead the First Article Inspection exchanging roles with the other engineering functions. All participants must be trained as identified in this procedure.      

9. MPROC First Article Inspection - Process Matrix

10. MPROC First Article Inspection MPR-PPC-WI-009805
What?
First Article Inspection (FAI)
When?
This procedure shall be performed prior to full production startup and release to ensure that manufactured product is meeting applicable packaging, labeling and manufacturing documents when:
Processing an assembly for the first time
Processing a new PIN that is similar to one previously manufactured, except if it contains significantly different literature or labeling.
Processing a new packaging / labeling configuration
After revalidating the packaging or labeling process.

11. MPROC First Article Inspection MPR-PPC-WI-009805
How?
Full FAI
First Article Inspection unit or Label is generated
Selecting a minimum of one unit from the first production build of the End Item/UPN. Units selected for inspection should be selected from product that is intended for distribution OR
Manufacture the first article through an engineering special built.
Equivalence FAI
For FAI via equivalency, a physical inspection to the end item is not required.
The End Item and its components must be at minimum released to preproduction status prior to performing the FAI.

12. MPROC First Article Inspection MPR-PPC-WI-009805 – Procedure Steps
Retrieve product information and End Item configuration, as applicable.
The following will be confirmed from the retrieved information (as applicable):
Part numbers are configured in FW
Process Plans are configured in FW
FW configuration is aligned with product BOM
Applicable documents were modified
UPN numbers are correctly configured
As applicable, verify that the label information was configured correctly on all part numbers/PIN that belongs to the End Item Family. One Label of each PN/PIN must be printed and kept as evidence of this verification. The evidence (labels) shall be included as part of the First Article Inspection Report, MPR-PPC-FRM

13. MPROC First Article Inspection MPR-PPC-WI-009805 – FAI Classification
Full First Article
Applies when the End Item is manufactured for the first time.
Equivalence First Article
If the End Item is equivalent to either an existing and fully-inspected End Item, or an End Item undergoing a full inspection under the same report, then the FAI may be modified under the criteria identified below. Complete documentation of the rationale for the equivalence that must be included in the Equivalence Rationale section of the FAI Report. Final signature approval of the FAI Report with equivalence selected indicates agreement with the equivalence rationale.
Partial Equivalence First Article – For the partial inspection, an assessment must be performed that documents the fully inspected End Item, identification of the differences by name and revision of the configuration items, and rationale to support the partial equivalence. The assessment shall address any design requirements and manufacturing set up data that could alter the output of the manufacturing build process. The assessment will also indicate which requirement checks must still be performed.

14. MPROC First Article Inspection MPR-PPC-WI-009805 – FAI Classification
Sample on documentation of the rationale for Equivalence First Article
Partial Equivalence Rationale
Previous FAI Report used for equivalence (if required)
Identify the fully inspected End Item/UPN from which the equivalency assessment is performed and identify the associated FAI Report.
For Sterile Pack Configuration: 3391S0000V as per FAI Report 08FAI.020 .(See Attachment I)
For Final Pack Configuration: 3391S4000V as per FAI Report 09FAI.011.(See Attachment II)
Equivalence Rationale
Describe the equivalence assessment. Identify differences by name and revision of the configuration items. Provide justification.
At Final Pack level the difference between PIN 3391S4001V (Rev B.) and the one represented on FAI Report 09FAI.011 is that the Manual MA10554A003 (Rev. A) was replaced by MA10554A004 (Rev. B) and Registration Form (Rev. B) was replaced by Registration Form M182894M004 (Rev. A). Also Manual MA10549A003 (Rev. A) and Instruction Sheet (Rev. A) were eliminated and new literatures were included as the Manual M940134A001 (Rev B.) and Indication Insert M945946A001 (Rev A.). Due to these differences in literature the equivalence is waived partially with PIN 3391S4000V.

15. MPROC First Article Inspection Report - MPR-PPC-FRM-009803
FAI Report, MPR-PPC-FRM
Complete the inspection checklist as each inspection check is performed in the yellow rows.
All applicable checks of the inspection section must be marked to indicate the requirement was met “Yes”, not met “No”, not applicable “N/A” or equivalent “EQ”. If “No” is checked, record the discrepancy for the requirement not met in the comment section. Also record rationale in the comment area for those checks marked “N/A”.
Upon completion, the “Pass” or “Fail” result box of the FAI Results box must be checked for each End Item/UPN inspected.
If any of the listed inspection checks for an individual End Item/UPN are not met, the “Fail” box must be checked.
All corrective actions and verification information addressing discrepancies resulting in a “Fail” shall be documented in the FAI Report.

16. MPROC First Article Inspection Report - MPR-PPC-FRM-009803
FAI Closure
To be completed satisfactorily all questions must be completed with acceptable results.
The QE representative, when applicable, and the Packaging / Manufacturing Engineering representative will approve the First Article through the applicable system.
Any others participating in the First Article Inspection process may optionally sign their approval.

17. MPROC First Article Inspection Report - MPR-PPC-FRM-009803

18. MPROC First Article Inspection Report - MPR-PPC-FRM-009803

19. MPROC First Article Inspection Report - MPR-PPC-FRM-009803