Spreadsheet: 152309d1335338913-subtracting-dates-practice-sheet
Sheet: Sheet2

Subtask # | Creation User Dept | Initiation Date | [NAME] | Non-conformance | Action Required
15637 | SQA Galway-Ireland | 2011-04-03 00:00:00 | Optinova AB | (PTA - Noel Conway) | Notification
 |  |  |  | 23/84 samples measured out of spec. As per specification 90517035, min [NAME] to be 0.145". OOS readings range from 0.139" to 0.144".
15639 | SQA Galway-Ireland | 2011-04-03 00:00:00 | TRANSTEST EQUIPMENT | A BSIL owned Instrument, namely, Gencal Control Electronics Package (CEP) 220V Display (BSIL (D# TE9247, Serial # 780439) was shipped to [NAME] in Maynooth on 13-Oct-10 for periodic Calibration. This unit cannot be located since its shipment from Transtest to Advanced Energy. | Correction
 |  |  |  | Calibration ; [NAME]
15686 | SQA Galway-Ireland | 2011-10-03 00:00:00 | [NAME] | 1) The EO Gas supply temperature during gas injection for load [PHONE] was 28.1C.The specification is 30-60C. This non conformance resulted in delay of release of this load. | Full SCAR
 |  |  |  | 2) Pallet no. 7 from Bulach load [PHONE] was not removed from the chamber on completion of the sterilization phase and was processed in the next cycle ( 40C [PHONE])
 |  |  |  | reached pressure of 112 mbar
15703 | SQA Galway-Ireland | 2011-11-03 00:00:00 | Nelipak Thermoforming Ireland | BSC Receiving personel found that Part Number 806822-01, Nelipak Lot Number BS47221B and PO Number 6255048 had status "No Inspection Required " documented on the outer box labels and status "Inspection Required" documented on the inner box labels. | Correction
 |  |  |  | The required Inspection Status for outer box labels is 'Inspection Required' per BSC Labeling procedure 90026179.
 |  |  |  | SQE - Padraig McNulty
15732 | SQA Galway-Ireland | 3/16/2011 | [NAME] | [NAME] have an unspecified shiny residue present on the circular section part of the label resulting in poor quality print reported in this section during overprint operation. | Full SCAR
 |  |  |  | SES - [NAME]
15802 | SQA Galway-Ireland | 3/24/2011 | TOOL & PLASTIC CO LTD | (SES - [NAME]) | Full SCAR
 |  |  |  | TD0052-003 batch [PHONE] - 17 out of 44 samples tested for OD are Out of spec. 10 samples have a reading of 0.185 inches, 7 samples have a reading of 0.184 inches.
 |  |  |  | As per specification TD0052-00 rev AC, Dim B to be 0.187" +/- 0.001".
15855 | SQA Galway-Ireland | 3/30/2011 | [NAME] | There are 2 issues to be addressed under this SCAR: | Full SCAR
 |  |  |  | 1) An Air trap in the chamber jacket around the chessel monitoring probe 2 caused a localized increase in chamber temperature in that area of the chamber . Chamber temperature read at 47.0C ( specification is <46.0C) for load [PHONE].
 |  |  |  | 2) The master batch record for the cycle was submitted for review prior to identification of the issue on cycle.
15870 | SQA Galway-Ireland | 3/31/2011 | Optinova AB | PTA | Full SCAR
 |  |  |  | Wingtool received on the 24-Mar-11 failed Dimension 'B'. Difficulty in removing the min. pin gauge 0.094" from 4/29 samples tested.
15897 | SQA Galway-Ireland | 2011-05-04 00:00:00 | Perfecseal Ltd. | On March 28th, a Product Builder on the evening shift in Inner Packaging identified a header bag that had a possible | Full SCAR
 |  |  |  | vendor seal width out of specification. The Quality Technician confirmed the out of specification condition with a
 |  |  |  | reading of 4.4mm on the top seal (specification is 9.5+/-3.2mm). 17 OOS seal width issues were identified in subsequent inspection of the full batch of header bags; 6 units were confirmed as having a seal breach
 |  |  |  | (tyvek to polyethlene end - top seal).
 |  |  |  | POBA - Lorraine Cheevers
15908 | SQA Galway-Ireland | 2011-06-04 00:00:00 | [NAME] | There are 2 issues to be addressed under this SCAR | Full SCAR
 |  |  |  | 1) Sterile Run [PHONE] spent 1 hour and 28 minutes too long in Degas
 |  |  |  | 2) The master batch record for the cycle was submitted for review prior to identification of the issue on cycle
15942 | SQA Galway-Ireland | 2011-11-04 00:00:00 | York Label | Print outline border line missing in specified sections of the label (including top border and circular section) of 200 labels received - refer to attached picture. | Correction
 |  |  |  | Roll identifier:
 |  |  |  | Job/Lot : 6064
 |  |  |  | Item code : 4621
 |  |  |  | Desc. 90244533-01 rev B
 |  |  |  | Slit ~ NA
 |  |  |  | Qty 700
 |  |  |  | Trace ID # 178183
 |  |  |  | POBA - Lorraine Cheevers
15979 | SQA Galway-Ireland | 4/14/2011 | FOSTER CORPORATION | (PCT [NAME]) | Full SCAR
 |  |  |  | [NAME] has been accepted into BSC with incorrect pellet size. SCAR is required to highlight Issue to the Vendor. The pellet size should be:
 |  |  |  | 0.100” +/-0.020” diameter, 0.100” +/- 0.030” in length.
 |  |  |  | The smaller the pellet size the harder it is to process the resin.
15989 | SQA Galway-Ireland | 4/15/2011 | Schenker (Ireland) Ltd. | SCAR requested by [NAME]) | Full SCAR
 |  |  |  | There are 3 issues being reported in this SCAR as follows:
 |  |  |  | 1- H749100953912B0 & H749100954628B0 was shipped to Quincy via SCHENKER IRELAND LIMITED product was in damaged in transit.
 |  |  |  | Damage was noted on receipt into Quincy on the POD.
 |  |  |  | Product was scrapped in Quincy.
 |  |  |  | 2-Labels ( 90375893-01) shipped to BSC Galway from York Labl via SCHENKER IRELAND LIMITED were damaged in transit.
 |  |  |  | Damage was noted on receipt into BSC on the POD.
 |  |  |  | Labels were scrapped.
 |  |  |  | 3- Cartons ( 90585656-01) shipped to BSC Galway from Unisource by subcontracting freight provider R.Lynch for SCHENKER IRELAND LIMITED; the delivery was signed for as damaged on receipt at BSC on R.Lynch delivery rota paperwork.
 |  |  |  | Cartons were scrapped.
16005 | SQA Galway-Ireland | 4/18/2011 | Specialty Coating | PCT - Part failed incoming Inspection as per Incoming Inspection procedure for PCT Mandrels, 90538647. | Full SCAR
 |  |  |  | 1. Sharp edges present and mandrels are not smooth on the samples tested as per drawing 90511708-00.
 |  |  |  | 2. Mandrels were unable to fit into the length fixture. Cannot be processed in Mouldings. REF NCEP 00004478.
16023 | SQA Galway-Ireland | 4/20/2011 | Steripack Ltd | An operator completing [NAME] and Pouch Step noticed that 20 pouches were not manufactured to specification, chevron seal and hang hole positions were misaligned. | Full SCAR
 |  |  |  | PTA - Aoife [NAME]
16030 | SQA Galway-Ireland | 4/21/2011 | Merrill Brink International | SQA - Translation issues identified with DFU - Express LD Vascular 90484578-01, -02, -07. | Full SCAR
 |  |  |  | BSC Galway requires confirmation from Merrill Brink as to when these DFUs were processed through their translation system.
 |  |  |  | The non conformances are attached to this subtask in Attachment named "Attachment # 1 to Supplier Corrective Action Request #16030".
16074 | SQA Galway-Ireland | 4/27/2011 | Perfecseal Ltd. | POBA - 1 headerbag had a hole (drag damage) along the Tyvek side and through plastic layer. Another headerbag appears to have been cut at an angle through the seal as opposed to a straight cut. | Full SCAR
16180 | SQA Galway-Ireland | 2011-04-05 00:00:00 | TOOL & PLASTIC CO LTD | SES | Full SCAR
 |  |  |  | TD0052-002 batch [PHONE] - yield fallout. 20 aditional units had been sent to Incoming Inspection to be measured and 18 were out of specification as per incoming inspection requirement on dimension [NAME] for reference.
16181 | SQA Galway-Ireland | 2011-04-05 00:00:00 | Accellent Cardiology Salem | PTA - Accellent Cardiology Salem the part manufacturer for Part no 5000486-22 identified that all RO markers manufactured from Lot # 832017 were not annealed as per manufacturing requirements due to an operator error. | Full SCAR
 |  |  |  | Accellent Cardiology Salem contacted Boston Scientific to highlight this issue & to ensure all RO markers from part were not used.
16199 | SQA Galway-Ireland | 2011-09-05 00:00:00 | CREGANNA - TACTX MEDICAL | 1 part failed in process inspection for blocked Hypotube. | Full SCAR
 |  |  |  | PCT - Trish [NAME]
16221 | SQA Galway-Ireland | 2011-11-05 00:00:00 | [NAME] | 1 carton found in the POBA packaging area of CE 8 which had a partial opening along the vendor side seal approximately 9-10cm in length at the bottom right hand corner. | Full SCAR
 |  |  |  | POBA [NAME]
16228 | SQA Galway-Ireland | 2011-12-05 00:00:00 | Avicenna | PTA | Full SCAR
 |  |  |  | It was noted on the 26th APR 2011, that the shrink tubes had slits on both ends of the tubing resulting in product weld damage.
 |  |  |  | On review of the batch as part of NCEP 00005402 other defects were identified were.
 |  |  |  | 1. Wrong length
 |  |  |  | 2. No slit present
 |  |  |  | 3. Slits present at both ends
 |  |  |  | 4. Slit present at one end, but only on one side slit cut.
16235 | SQA Galway-Ireland | 2011-12-05 00:00:00 | Schlotter Ireland | On the 21st of March 2011, the Receiving Department advised MCT that the specification for the Phosphoric Acid component of PCA Etch batch # [PHONE] on the COA was different to that on the material specification (90409506-02). The material specification states that the specification is 9.05 – 9.19 M/L, and the COA states that the specification is 9.05 – 9.20 M/L | Full SCAR
16277 | SQA Galway-Ireland | 5/18/2011 | Meadwestvaco Consumer Packaging | 22 samples taken from material 90580846-01 vendor lot # 102009-1 all have cosmetic print defects present. | Full SCAR
 |  |  |  | Ink displacement / ink splashes (white spots|) are present on the edge of cartons inspected.
 |  |  |  | SES - Carol Roche.
16280 | SQA Galway-Ireland | 5/18/2011 | Optinova AB | PTA - There was an issue with Dimension 'B'. Difficulty in removing the min. pin gauge 0.094" from 4/8 samples tested. | Full SCAR
16323 | SQA Galway-Ireland | 5/23/2011 | BSC - Maple Grove | Incomming | Full SCAR
 |  |  |  | When verifying shipments per Packing List [PHONE] the receiving inspector identified a mismatch in the batch number for resin material P/N 04610-02 between the label on the 2 boxes received and the batch number on the packing list.
 |  |  |  | The Packing List, as drawn from SAP, detailed the batch number as [PHONE] and the label on the boxes received detailed batch number [PHONE], Material was received from Maple Grove site.
16431 | SQA Galway-Ireland | 2011-08-06 00:00:00 | Accellent Cardiology Salem | NCEP-00006461 | Full SCAR
 |  |  |  | On the 24 May 2011an Operator was loading [NAME]-bands prior to the Marker-band Crimp Work step when he noted that one of the [NAME]-bands in Marker-band Vendor Lot # 839805 was Platinum in colour as opposed to the required Gold.
 |  |  |  | POBA - [NAME]
16488 | SQA Galway-Ireland | 6/15/2011 | GW Plastics | SES | Correction
 |  |  |  | 8.5 FR Tips 90159520-01 batch [PHONE] (qty of 3960) had been received in Incoming Inspection on 15 Apr 2011 (Attachment 1 - receiving traveler).
 |  |  |  | During inspection as per 90159520 drawing it was noted that 2 out of 29 samples measured for length are out of specification limits. See attachment 1 page 4 - for results. First sample shows a reading of 0.37-0.39 inches and second is 0.43 inches long where specification limit is 0.45 +/-0.01 inch. See attachment 2 - drawing, for reference.
 |  |  |  | As tested units did not meet specification limits whole batch of 3960 units had been placed on hold and NCEP00005303 had been initiated to document the issue.
 |  |  |  | There is no impact to product quality as parts were not introduced into production
16509 | SQA Galway-Ireland | 6/16/2011 | Schenker (Ireland) Ltd. | (PRODUCT RELEASE) Issue 1-Inbound Shipment from Donatelle Plastics, MN was mislaid en route via Chicago to BSIL plant Galway. | Notification
 |  |  |  | Issue 2-Outbound Shipment from BSIL Galway plant via Shannon and Boston and forwarded onto Denver was mislaid in the Denvor depot.
16521 | SQA Galway-Ireland | 6/17/2011 | Perfecseal Ltd. | Material 821246-001 batch 297602 was received without inner labelling present as required on 8 from 9 boxes inspected during Incoming Inspection. | Correction
 |  |  |  | SES - [NAME]
16598 | SQA Galway-Ireland | 6/27/2011 | Perfecseal Ltd. | Material received from supplier Perfecseal with the delivery documentation | Full SCAR
 |  |  |  | recording PO# 6270314.
 |  |  |  | Perfecseal COC and the outer container labels with PO# 6259210 recorded.
 |  |  |  | SQE - Padraig McNulty
16685 | SQA Galway-Ireland | 2011-06-07 00:00:00 | BSC - Maple Grove | One stent from [NAME] (BSB) 14396737 displaying gross strut damage (gouge) was detected at Coatings Final Inspection. PO# [PHONE] Lot # 14396737 DES - Noel Reapy | Correction
16691 | SQA Galway-Ireland | 2011-07-07 00:00:00 | [NAME] | Parts inner labelled incorrectly, the part number 90567536-01 on the inner label applied to the inner bag does not match the part number 90320208-01 of the delivery and on the label rolls on some boxes identified during Warehouse review. | Full SCAR
 |  |  |  | SQE- [NAME]
16692 | SQA Galway-Ireland | 2011-07-07 00:00:00 | Amcor Flexibles | Damaged delivery received in BSC Galway for part # 90534768-01 lot # 024233 from delivered qty of 100,000. | Full SCAR
 |  |  |  | 1 of the pallets was damaged - looks like fork-lift damage , 3 of the cartons were damaged on this pallet, 1 significantly damaged (Qty 750).
 |  |  |  | Taxus - Noel Reapy
16721 | SQA Galway-Ireland | 7/13/2011 | PUTNAM PLASTICS CORPORATION | SES | Correction
 |  |  |  | Units failed during production for upper and lower OD specifications limits.
16763 | SQA Galway-Ireland | 7/19/2011 | Minnesota Rubber | Incomming Inspection | Notification
 |  |  |  | Inner labels at the wrong rev. [NAME] and COC at rev D label showing rev C. PO went through on 11th May 2011 and last part rev change went through on the 17th December 2010 so Inner labels should be at rev D.
16811 | SQA Galway-Ireland | 7/25/2011 | Schenker (Ireland) Ltd. | SES - Upon receipt of a delivery of this material (90316935-01, [NAME], Qty: 5,103 from Prent via DB Schenker Ireland Limited), 1/27 shipper cartons contained visible external damage. | Full SCAR
 |  |  |  | The damaged shipper carton failed to meet BSIL specifications and therefore is unfit for use in production.
 |  |  |  | This carton contained 189 finished product cartons which have been scrapped at BSC Galway.
 |  |  |  | DB Schenker Ireland Limited AWB # for Prent shipment is MSN-08006729.
16864 | SQA Galway-Ireland | 7/29/2011 | [NAME] | The EO gas injection phase went over specification by 112 minutes; | Full SCAR
 |  |  |  | specification is 14 - 60 minutes).
16911 | SQA Galway-Ireland | 2011-03-08 00:00:00 | Amcor Flexibles | (sqa)Per the 90534768 vers. AB print, note 7, minimum seal strength is 4.5 lb/in. | Full SCAR
 |  |  |  | Units from lot BSC Lot # [PHONE] transferred from BSC Galway to BSC Maple Grove exhibited a weakness in the weld seal (approx 30mm in length) on the lower of one side of the pouch which allowed a breach of the seal with application of neglible pressure.
 |  |  |  | As of 25 Jul 2011, the number of non-cornforming and suspected non-conforming parts is 1504.
16927 | SQA Galway-Ireland | 2011-03-08 00:00:00 | [NAME] | The preconditioning phase went over specification by 4 minutes. | Full SCAR
 |  |  |  | This out of specification was not picked up by [NAME].
 |  |  |  | It was noted by the Sterilization QA Release group when reviewing the paperwork for release.
16956 | SQA Galway-Ireland | 2011-08-08 00:00:00 | [NAME] | [NAME] Testing of Stability Samples | Correction
 |  |  |  | Event Date: May 2011
 |  |  |  | [NAME] > BSC Batch # 13368151 (T12 25/60) tested per stability protocol 90469307; Nelson Sample ID 579502 > BSC Batch #s 13357594 (T12 25/60) & 13339029 (T12 25/60) per stability protocol 90469307.
 |  |  |  | The samples tested in SCDB media (sterility testing) were inadvertently misplaced, and consequently it was not possible to generate data (per Procedure STP0081 Rev. 09). Additional samples were sent to [NAME] labs for testing
17004 | SQA Galway-Ireland | 8/16/2011 | Merrill Brink International | PTA * Translation issues on the DFU Part # 90673695-01 – first receipt of the part. | Full SCAR
 |  |  |  | A review was completed of the translation issues & it was determined that in the "Intended use section", Page 5 & 14, the sentence "The Mustang Balloon Dilation Catheter is also indicated for post dilation of balloon expandable and self -expanding stents in the peripheral vasculature" was not translated from English to Italian or Spanish
17013 | SQA Galway-Ireland | 8/17/2011 | [NAME] | In using label part number 90557989-01 / vendor lot number FD157577 during SES Inner Pack some information on the printed label was illegible after overprinting (approx every 10th label ) due to a crease on the label roll. | Full SCAR
 |  |  |  | SES - Marianne McGrath
17116 | SQA Galway-Ireland | 8/31/2011 | Butterworth | Incomming | Notification
 |  |  |  | The Absorbance test method was not followed correctly by Buterworth labs and the results were void due to the delay in carrying out the test. Test should be carried out 24 hours after opening the bottel’s.
17131 | SQA Galway-Ireland | 2011-01-09 00:00:00 | Optinova AB | SDC | Full SCAR
 |  |  |  | 10 out of 90 samples failed both OD and ID dimensions.ref 90507281-35 for material specifications.OD and ID dimensions. ID spec 0.60+/-.001 OD Spec .109+/-0.15.
17148 | SQA Galway-Ireland | 2011-05-09 00:00:00 | Ansamed | PTA | Full SCAR
 |  |  |  | On the 23rd August 2011 it was noted by the operator at the balloon catheter inspection step on the PDP OffRoad line that some test balloon catheters were restricted. The raw inner tube extrusions on line at the time were reviewed ie a random sample of 30 parts were inspected 25 were very tight or restricted on the insepction guidewire. All remaining part in BSC were placed on hold ie 380. NCEP was raised to investigate the issue.
 |  |  |  | Parts affected = inner tubes material # 90649150-01, batch # [PHONE].
17152 | SQA Galway-Ireland | 2011-06-09 00:00:00 | Amcor Flexibles | Per the 90534768 vers. AB print, the pouch has a continuous seal on three sides. | Full SCAR
 |  |  |  | Two units from BSC Maple Grove lot # [PHONE]( Amcor Sligo - vendor lot # 022544) , sister site receipt from BSC Galway, exhibited a length of red tape on both the inside and outside of the pouch where a mill splice had occurred.
 |  |  |  | The red tape in continuous through the seal of the pouch and does not provide a continuous vendor seal.
 |  |  |  | Supplier Quality - Padraig McNulty
17153 | SQA Galway-Ireland | 2011-06-09 00:00:00 | Perfecseal Ltd. | [NAME] short trays TD0414-001 contain a molding deformity in the same location on each affected tray . | Full SCAR
 |  |  |  | The product device cannot be loaded correctly into the tray with the deformity present.
 |  |  |  | SES - Marianne McGrath
17179 | SQA Galway-Ireland | 2011-09-09 00:00:00 | [NAME] | [NAME] processed [NAME] product family under the [NAME] product family processing code (‘cycle’). | Full SCAR
 |  |  |  | [Galway Load [PHONE], delivery # [PHONE]]
17202 | SQA Galway-Ireland | 9/13/2011 | Avicenna | SDC VS | Correction
 |  |  |  | Distal h/s units found below specification. Spec is 21.000 +/- .375 mm, the sample that failed was 19.00mm
17206 | SQA Galway-Ireland | 9/13/2011 | Pro Tek | DES | Full SCAR
 |  |  |  | 2 boxes of the crosswire fixture batch # [PHONE] (vendor batch # 10004158) when brought to lines 3 & 4 in CE9 (DES Promus) were found to cotain fixtures with a smaller than expected crosswire fixture portion.
 |  |  |  | Investigation subsequentoy established that these fixtures were size 12mm not the expected 16mm as per batch identifying labelling. We will be returning the 2 lots (4 boxes of [PHONE] (3360) and 6 boxes of [PHONE]( 5040).
17232 | SQA Galway-Ireland | 9/20/2011 | York Label | During the processing of Tyvek labels 90244533-02, BSC Batch no. [PHONE] issues were found during the printing of associated labels. | Full SCAR
 |  |  |  | On review of label, it was found that the cut out region on a section of the labels were inadequate resulting in the label not disengagng from the backing paper of the label.This is causing the printer to jam after every second label.
 |  |  |  | DES - Fionnuala Boyle
17267 | SQA Galway-Ireland | 9/26/2011 | Amcor Flexibles | Amcor Flexibles Sligo shipped BSC Galway 150,000 units of vendor batch number 024242 on the 26th Aug 2011. | Full SCAR
 |  |  |  | BSC Galway shipped 28,488 units from this batch under BSC batch number [PHONE], on the 09 Sept 2011.
 |  |  |  | On the 20 Sept, BSC Maple Grove noted 4 pouches from this batch had issues as outlined below;
 |  |  |  | (1) only 1 notch present
 |  |  |  | (2) 2 notches not cut out (there is evidence of notch engagement)
 |  |  |  | (3) no notches present
 |  |  |  | (4) no notches present
 |  |  |  | As a result [NAME] contained the material (28,488 units) at their facility via NCEP # 00010053.
 |  |  |  | None of this batch has been used in BSC Galway and all 121,483 units have been placed on hold in the Warehouse.
 |  |  |  | 29 units were scrapped as part of routine incoming inspection on the 29 Aug which accounts for the remaining units from this batch.
 |  |  |  | The four units were detected in Amcor Sligo carton number 192 and packet number 0292B.
 |  |  |  | Supplier Quality - Padraig McNulty
17269 | SQA Galway-Ireland | 9/26/2011 | Limmatdruck AG | 42 cartons were detected (from one box qty of 175) during product box pack inspection process to be open at the top and bottom end of the cartons seams. | Full SCAR
 |  |  |  | The affected units were open approx. 100mm from either end with a glue line present on affected cartons – refer to attached pictures.
 |  |  |  | An additional 31 defective units was detected after completion of sort activity under NCEP 00011184.
 |  |  |  | SES - [NAME]
17281 | SQA Galway-Ireland | 9/28/2011 | TOOL & PLASTIC CO LTD | (SES) NCEP 11318 was initiated for 1/44 valve body being out of spec for ‘Dim A’ for LN [PHONE]. This was discovered during the Incoming Inspection testing process. | Full SCAR
17331 | SQA Galway-Ireland | 2011-05-10 00:00:00 | Cable Accessories | SES | Correction
 |  |  |  | Contaminated material identified as part of in process control 90621119. The operator detected contaminated tubing when inspecting material 12-1070, BSIL batch [PHONE] (vendor [NAME]). Operator must inspect material 12-1070 as per procedure 90621119 (SGOI for Cut to Length). Operator must visually inspect tubing for cosmetic damage prior to use, if FM/Blemishes/Damage are noted on tubing then operator can cut out section affected and dispose. However, if defect is along all of tubing then the operator must dispose of tubing and notify a Core Team member.
 |  |  |  | In this case, the operator detected contaminated tubing when inspecting material 12-1070, batch [PHONE] (vendor [NAME]). Tubing felt greasy and slippy to the touch. Operator highlighted the issue to the Core Team immediately and an investigation was initiated. Further investigation of the issue, noted that when cleaned with a wipe and 70% IPA, black FM was evident on the wipe. In addition, due to the tubing defect it was not possible to process the affected tubing through the cutting fixture. Material was slipping and therefore could not be cut as per procedure 90621119
17356 | SQA Galway-Ireland | 2011-10-10 00:00:00 | Meadwestvaco Consumer Packaging | During Incoming Inspection of BSC lot # [PHONE]: | Full SCAR
 |  |  |  | Samples were taken from 7 boxes as per sampling procedure 90175514.
 |  |  |  | Some units were found to have cosmetic issues, i.e. colour finish smeared.
 |  |  |  | DES - Noel Reapy
17357 | SQA Galway-Ireland | 2011-10-10 00:00:00 | York Label | (DES) - Artwork content missing from labels that were received from supplier. | Full SCAR
 |  |  |  | The Pantone 3115C Light Blue on BSC branding masthead of the label stock is missing from a portion of labels on the affected roll.
17428 | SQA Galway-Ireland | 10/21/2011 | Merrill Brink International | (R&D Design Assurance)TAXUS Element Direction for Use was translated to French by Merill Brink Int. | Full SCAR
 |  |  |  | During a translation review by a Boston Scientic French Regulatory representative, it was highlighted that the Intended Use/Indications section was incorrectly translated.
 |  |  |  | This DFU, 90608994-01 has not left BSC control as it is still going through the development process.
 |  |  |  | The current TAXUS Element DFU on the OUS market is correctly translated.
17561 | SQA Galway-Ireland | 2011-02-11 00:00:00 | Mangar Industries Incorporated | All 29 sample pouches failed length inspection from batch 271263/1/B | Full SCAR
 |  |  |  | (part number #90478668-01).
 |  |  |  | Specified length is 1516.1mm +/- 5.1mm as per drawing 90478668.
 |  |  |  | Sample pouches measured 1508mm - defective units were identified in Mangar bundle numbers: 13,16 & 17.
 |  |  |  | SES - Andrew Connaire
17582 | SQA Galway-Ireland | 2011-03-11 00:00:00 | Butterworth | Supplier Quality | Notification
 |  |  |  | As per the test method and test method validation PN 90206742, the equipment & material to be used is "Disposable plastic transfer pipette". However in the report that was
 |  |  |  | provide by butterworth it state that a glass pipette is used and this is a deviation to the test method.
17586 | SQA Galway-Ireland | 2011-03-11 00:00:00 | RDM Test Equipment | Calibration - The Non-conformances relate to two issues: | Full SCAR
 |  |  |  | A) Issues with the transcription of calibration results from vendor hand written reports to the Vendor reviewed and approved Certificates of Calibration provided to BSC Galway.
 |  |  |  | B)Issues with the calculation of error readings on Certificates of Calibration provided to BSC Galway.
 |  |  |  | 1-Certificate of Calibration # 3865/1011
 |  |  |  | On the original issue of this Certificate, reviewed by the BSC Calibration Department on 25/Oct/2011, the Final Pressure Readings for the Applied Load range of 0 - 100 lbsf/in2 applied load on the Jaw Pressure Calibration G2983 were missing.
 |  |  |  | On the first amendment issue of the certificate, reviewed by the BSC Calibration Department on 27/Oct/2011, the Final error reading at 100Ibf/in2 applied load should have be -0.60 lbsf/in2 and not the reported -0.40 lbsf/in2.
 |  |  |  | 2-Certificate of Calibration # 3866/1011
 |  |  |  | On the original issue of this certificate, reviewed by the BSC Calibration Department on 25/Oct/2011, two issues were identified:
 |  |  |  | - the After readings for the pressure range of 20 - 50 psi for the Input Pressure
 |  |  |  | [NAME] were incorrectly calculated.
 |  |  |  | - the Final Readings Actual Error for the range 0 - 400oC for the Temperature
 |  |  |  | Calibration G17540 were incorrectly calculated.
 |  |  |  | On the first amendment issue of the certificate, reviewed by the BSC Calibration Department on 27/Oct/2011, the Dwell time readings for the Timer Calibration G17541 was recorded over a range of 0.10 to 10.00 seconds, but should have been at a single setpoint of 2.5 seconds as the machine is hardcoded to operate
 |  |  |  | at this single setpoint only.
 |  |  |  | 3-Certificate of Calibration # 3871/1011
 |  |  |  | On the original issue of this certificate, reviewed by the BSC Calibration Department on 25/Oct/2011, the after readings for the prossure range 10 - 50 psi for the Input Pressure Reading G18515 were incorrectly calculated.
17634 | SQA Galway-Ireland | 2011-08-11 00:00:00 | Perfecseal Ltd. | An excess of material at the edge of the vendor side seals at the the open bag end giving the affected pouches a dragged appearance that is detracting aesthetically from the quality appearance of the pouched units. | Full SCAR
 |  |  |  | DES - Joe Lynskey
17719 | SQA Galway-Ireland | 11/15/2011 | Laminated Films & Packaging | 3 pouches in sequence found with the following issues during PTA Symmetry line 2 product build and inspection: | Full SCAR
 |  |  |  | Pouch 1:
 |  |  |  | Chevron seal position in spec / Hang hole position out of spec.
 |  |  |  | Bottom of pouch contains additional Chevron seal and [NAME] hole.
 |  |  |  | Pouch 2:
 |  |  |  | No Chevron seal or [NAME] hole present
 |  |  |  | Pouch 3:
 |  |  |  | Issue1:
 |  |  |  | Hang hole position in spec & Chevron seal out of spec.
 |  |  |  | Issue 2:
 |  |  |  | Open left and right side seal (183mm from top and 50mm in length).
 |  |  |  | No sealing impression in 50mm opening - sealing impression either side of 50mm opening.
 |  |  |  | After completion of 100% pouch inspection of reamaining qty of batch number [PHONE](Vendor lot# 216359) an additional 8 defective pouches were found.
 |  |  |  | 100% inspection was additionally completed on batch numbers, [PHONE] / vendor batch number 216956 & [PHONE] / vendor batch number 216957 (material on site and received before notification of vendor of issue under [NAME]) with the following number of non conforming units identified:
 |  |  |  | 7 defective pouches identified in batch# [PHONE]
 |  |  |  | 8 defective pouches identified in batch# [PHONE]:
 |  |  |  | The vendor has confirmed that the root cause of above outlined defects is the same as root cause identified for batch number [PHONE](vendor lot# 216359).
 |  |  |  | The total number of non conforming units identified after completion of required 100% sort activivity = 26 units.
 |  |  |  | PTA - David Kiely
17786 | SQA Galway-Ireland | 11/21/2011 | SVS Industrial Supplies Ltd | Upon removing a box of R2A media lot # [PHONE] Exp: 10-Nov-2011 from the refrigerator for use, it was noted that there was contamination i.e. growth, on a number of plates. Each box of media contains 2 sealed packets containing 10 plates. The growth was observed through the sealed packet of 1 packet of 10. The other packet showed no growth. | Notification
 |  |  |  | Each new lot of media is received into the Microbiology Lab with a Quality Control Certificate and also growth promotion is carried out in-house. The lot of R2A in question passed in-house growth promotion testing on the 26Sep2011 - GAL Micro Lab - Mary Mc Fadden
17789 | SQA Galway-Ireland | 11/21/2011 | Donatelle Plastics Incorporated | POBA | Full SCAR
 |  |  |  | Two bags (2000 units) of 3 channel clip for coils , P/N 90401964-01, Batch Number 500117936 ( Vendor [NAME] 58746) were found not to be adequately sealed.
 |  |  |  | One bag was completely open and the second bag was partially open (incomplete seal.The part specification states that the "THE PARTS ARE TO BE MOLDED AND PACKAGED IN SUCH A WAY AS TOMINIMIZE LOOSE FOREIGN MATERIAL'
17874 | SQA Galway-Ireland | 11/30/2011 | [NAME] | *ANALYTICAL LAB* -Mix up of sample allocation to Finished Goods batch numbers during stability testing. | Full SCAR
17878 | SQA Galway-Ireland | 2011-01-12 00:00:00 | Optinova AB | DES | Full SCAR
 |  |  |  | During the processing of FGB #14839059 through the Crimp Inspection workstep, the Product Builder highlighted to the Quality Representative that Stent protectors (batch# [PHONE], part#90507281-28) did not contain a flare on both sides as per specification.
17898 | SQA Galway-Ireland | 2011-05-12 00:00:00 | [NAME] | [NAME] 18-Nov-2011, [NAME] received [NAME] , Delivery [PHONE] From Plant M550 Galway. | Notification
 |  |  |  | The paperwork that arrived with this shipment was the paperwork for [NAME] .
 |  |  |  | When SYNERGY HEALTH IRELAND LTD were preparing the load for shipment, the operator placed the PSRR for the load on the incorrect pallets, so this incident was caused by human error at the suppliers facility.
 |  |  |  | To overcome the issue, [NAME] and [NAME] both accessed the correct forms via Sharepoint. When the load is released to the Steriliser, the Galway Product Release team, upload a copy of the PSRR test to a sharepoint site, that is accessible by the DCs.
 |  |  |  | As part the investigation, [NAME] was contacted to confirm which documentation was missing. It was confirmed the packaging list was correct, but the incorrect PSRR form was with the load. A review of the Galway process showed that the PSRR form is not attached to the pallet prior to shipment to sterilisation. The PSRR form is placed in an envelope and sent with the courier driver taking the load to the contract steriliser.
 |  |  |  | The Contract steriliser SYNERGY HEALTH IRELAND LTD, are then responsible for attaching the PSRR form to the correct load post sterilisation.
 |  |  |  | The Contract steriliser, SYNERGY HEALTH IRELAND LTD was then contacted, and notified of the issue.
17937 | SQA Galway-Ireland | 2011-08-12 00:00:00 | Meadwestvaco Consumer Packaging | During box pack inspection it was noted that the colour of the corner flag of Liberte boxes part number 90534201-02 batch # [PHONE] contains two shades of green on affected cartons with the darker shade not meeting part spec requirements of MR Pantone 347C Green E</=2.0 - refer to attached pictures. | Correction
 |  |  |  | POBA - [NAME]
17992 | SQA Galway-Ireland | 12/14/2011 | [NAME] (Ireland) Limited | Bi-Tube (34955-41) batch [PHONE] only had a single flare on one end of the Bi-Tube. SDC: [NAME] | Full SCAR
17993 | SQA Galway-Ireland | 12/14/2011 | Optinova AB | PTA - Open seals detected on inner packs of part number 90517035-06 at the Incoming Inspection Inner Labeling Process. | Full SCAR
 |  |  |  | 2 batches were inspected and the issue was found with both batches.
 |  |  |  | 200 units are contained in each inner pack.
 |  |  |  | Batch B3205510 = 2/6 bags with issue = 400 units affeced.
 |  |  |  | Batch B3207310- 7/19 bags with issue = 1400 units affected.
18177 | SQA Galway-Ireland | 1/19/2012 | [NAME] | [NAME] 16 Jan 2012 Kerkade DC received Load: [PHONE] , Deliveries: [PHONE] and [PHONE] From Plant M550 Galway. | Full SCAR
 |  |  |  | The paperwork that arrived with this shipment was the paperwork for Load: [PHONE] , Deliveries: [PHONE] -[PHONE] - [PHONE] and [PHONE] ; which is for the receiving DC: D275 Quincy; instead of the paperwork for Load: [PHONE] , Deliveries: [PHONE] and [PHONE], receiving DC: D525 Kerkrade
 |  |  |  | When Synergy were preparing the load for shipment the operator placed the psrr for the load on the incorrect pallets so this incident was cause by human error by the supplier
 |  |  |  | To overcome the issue, [NAME] and [NAME] both accessed the correct forms via Sharepoint. When the load is released to the Steriliser, the Galway Product Release team, upload a copy of the PSRR test to a sharepoint site, that is accessible by the DCs.
 |  |  |  | The Contract steriliser SYNERGY HEALTH IRELAND LTD, are then responsible for attaching the PSRR form to the correct load post sterilisation.
 |  |  |  | The Contract steriliser, SYNERGY HEALTH IRELAND LTD was then contacted, and notified of the issue.
18178 | SQA Galway-Ireland | 1/19/2012 | Minnesota Rubber | (SES ) | Full SCAR
 |  |  |  | IQA Material Quad Ring - Clear Lot [PHONE] failed Shore Hardness Testing (A) with an average value of 24, specification is 35-45 Shorehardness A.
 |  |  |  | During Investigation it was determined that the incorrect test slab was sent to BSC Galway for testing.
 |  |  |  | Document TD0068-00 outlines that the vendor supply one sample slab moulded from the same material used to produce each lot of this component.
18216 | SQA Galway-Ireland | 1/25/2012 | Steripack Ltd | It was noted during the processing of batches online through the packaging area that a number of pouches Material # 90675958-01 Batch # 44091 had issues with the edging of the clear plastic side of the vendor seal. | Correction
 |  |  |  | The clear plastic side of the pouch area was not cut flush with the bottom Tyvek section of the pouch and appeared to have jagged edges.
 |  |  |  | 32 defective units were identified from a lot qty. of 6,436 in use.
 |  |  |  | PTA - Grace Smyth
18265 | SQA Galway-Ireland | 2012-01-02 00:00:00 | Fort Wayne Metals Ireland LTD | All spools in this batch were labelled SPCN when batch is not SPCN material. SQA | Correction
18266 | SQA Galway-Ireland | 2012-01-02 00:00:00 | TOOL & PLASTIC CO LTD | SES) - Hub with incorrect ID found on line. | Full SCAR
 |  |  |  | Printed 8Fr Hub ID spec is 0.083” +/-.001.
 |  |  |  | Hub found on line was 0.109”.
 |  |  |  | Hub was marked as 8Fr.
 |  |  |  | Hub confirmed to be mouded by T&P.
 |  |  |  | NCEP 00016899 initiated to investiagte this issue and to document return of remaining quantities of affected batch (TD0006-020, BSIL Batch [PHONE], vendor batch 20116240) .
18268 | SQA Galway-Ireland | 2012-01-02 00:00:00 | [NAME] | Material 90320208-01, batch FD160786. | Full SCAR
 |  |  |  | Backing paper on the cut out section specified on the label has inadequate perforation i.e. cut-out not peeling off cleanly from the backing paper of the label - refer to attached graphic for location on label affected.
 |  |  |  | Qty 4,436 labels are impacted by this issue.
 |  |  |  | SES - Carol Roche
18287 | SQA Galway-Ireland | 2012-06-02 00:00:00 | Catalent Pharma Solutions Inc. | Incorrect data reported on CoA for batch release testing of Everolimus Active Pharmaceutical Ingredient (Part 90604369-01). | Full SCAR
 |  |  |  | GOAL QA - Liam Barron
18319 | SQA Galway-Ireland | 2012-10-02 00:00:00 | ANECTO LIMITED | During the Environmental conditioning of Synergy product for Design Verification (per 90049340 Corp SOP Distribution Challenge of Packaging) an Anecto Environmental chamber deviated beyond the specified range for Temperature. | Correction
 |  |  |  | Temperature range = 60 ±2 degrees. The chamber went beyond this range on a number of different occasions - refer to attached readout. This issue was highlighted at the time of occurrence by the vendor.
 |  |  |  | The units affect are for Design Verification testing only and it is intended to continue to use the units and note this in the report to protocol 90682417 as a worst case condition.
 |  |  |  | Product Details:
 |  |  |  | Product = Synergy, 4.0 X 8mm Lot# 14681586 Qty 15, 4.0 X 38mm Lot# 14792880 Qty 105
 |  |  |  | Ref Quote # BSCI012560ARGK
 |  |  |  | R&D - [NAME]
18343 | SQA Galway-Ireland | 2/15/2012 | CLONDALKIN PHARMA&HEALTHCARE (CHERRY ORCHARD) | It was noted during the processing of cartons through the packaging area that a number of Mustang Cartons had splitting along the side of carton part number 90558000-01 batch number 500102466 (vendor batch # 106341) - refer to attached picture. A glue line was present on the side seam of affected units. | Full SCAR
 |  |  |  | Qty 13 units detected to date for this issue.
 |  |  |  | PTA - Grace Smyth
18350 | SQA Galway-Ireland | 2/16/2012 | Perfecseal Ltd. | Portions of pre-printed text on header bag Part # 90519382-01 & Batch # 512784 were found to have missing/or illegible text in line - refer to attached picture. | Full SCAR
 |  |  |  | 32 units have been identified for this issue.
 |  |  |  | POBA - [NAME]
18385 | SQA Galway-Ireland | 2/22/2012 | Nelipak Thermoforming Ireland | Loose FM present on trays inspected during Incoming Inspection. | Full SCAR
 |  |  |  | PTA - Aoife [NAME]
18398 | SQA Galway-Ireland | 2/23/2012 | Ocon Chemicals | Microbiology Dept - On 05 Jan 2012, Ocon Chemicals Ltd, carried out a calibration of all MAS 100 and MAS 100NT Air Samplers onsite in the Microbiology Laboratory. Upon completion of the calibration, Calibration Certificates were generated for the following Air Samplers; | Correction
 |  |  |  | „«Serial Number 77729
 |  |  |  | „«Serial Number 67294
 |  |  |  | „«Serial Number 66935
 |  |  |  | „«Serial Number 65324
 |  |  |  | „«Serial Number 65323
 |  |  |  | „«Serial Number 65139
 |  |  |  | „«Serial Number 104219
 |  |  |  | „«Serial Number 104221
 |  |  |  | „«Serial Number 104220
 |  |  |  | A review could not be completed at the time of calibration as the SCS (SCS is the name given on the calibration certificate for the DA-100NT calibration unit. It is an accredited Swiss Accreditation Service) Calibration Certificate for the DA ¡V 100NT, could not be provided on the day by Ocon. The DA-100NT calibration system is a digital anemometer used to calibrate the MAS 100 and MAS 100-NT Air Samplers, in order to confirm the details documented on the calibration certificates this certificate is required.
 |  |  |  | (The calibration unit they use to do this calibration is called the DA 100-NT. Which is also a calibrated unit and is certified. Ocon enter details from this cert into excel worksheets which in turn does a calculation and produces the cert they provide to us. Ocon failed to supply us with the calibration cert of the DA 100NT on the day they were on site, therefore we couldn¡[NAME]t check the information they had entered on the certs they were giving us. It turned out they had a wrong value entered and therefore the calculation was incorrect.)
 |  |  |  | The DA-100NT Calibration Certificate was requested to be emailed to the Micro Department in order to complete the review of the calibration certificates. The certificate for the DA-100NT, serial number 15632 was received on Fri 06 Jan 2012. Upon review of the Air Sampler Calibration Certificates versus information documented on the Certificate for the DA-100NT, it was noted that there was incorrect and missing information on the Calibration Certificates for the Air Samplers issued by Ocon Chemicals Ltd.
18416 | SQA Galway-Ireland | 2/27/2012 | [NAME] | The following two issues were noted during POBA and PTA box pack inspection for vendor [NAME]: | Full SCAR
 |  |  |  | 1. POBA box pack inspection:
 |  |  |  | Portions of the box side seal was found to be incomplete on units from part number 90534201-11 and Vendor [NAME] 634732.
 |  |  |  | A glue line is present on the carton side seal of the affected units.
 |  |  |  | 8 units in total have been identified for this issue - refer to attached pictures.
 |  |  |  | 2. PTA box pack inspection:
 |  |  |  | Portions of the box seal side seal was found to be incomplete on units from part number 90566718-02 Vendor [NAME].
 |  |  |  | A glue line is present on the carton side seal of affected units.
 |  |  |  | 2 units in total have been identified for this issue - refer to attached pictures.
 |  |  |  | An additional open carton issue reported on 14 March 2012 per below has been added to existing Scar 18416:
 |  |  |  | 3. POBA Box pack inspection:
 |  |  |  | 8 cartons from part number 90534201-06, vendor batch number 634062 identified with partially open box side seals.
 |  |  |  | A glue line is present on the carton side seal of affected units.
18442 | SQA Galway-Ireland | 2012-01-03 00:00:00 | Perfecseal Ltd. | During in PTA in line inspection of part # 90566712-01, batch # 471585 4 units | Full SCAR
 |  |  |  | were found to have misaligned hang holes.
 |  |  |  | PTA - David Claffey