Opening Meeting

All department manager

Close out Observation of previous Audit

None

Close out CARSC0120

of Audit
QM-01/5 Quality policy and quality manual
15/10/2016
Ver. 5 Check the quality manual ,
Scope ,
Procedure list ,
Excluded and non-applicable table
7.5.1.2.2 , 7.5.1.2.3 , 7.5.3.2.2 and 8.2.4.2

Check quality policy signed from plant director Dr. Azza Rostom ,
communicated and understood

QP-01/5 Control of documents

QP-02/5
QP-03/5 The procedure implemented effectively ,in place and in use
QP-04/5
Check the master list of procedure of year 2016 ,
Issue date
15/10/2016 Update in company name , check the document change request at date 15/10/2016 in all
Version 5 procedures and QMS documents

Check obsolete document list

Check standard list , updated at 15/10/2016 by quality manager

QP-04/5 Control of records

Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
Check the record master list of year 2016 ,
Check the retention time , 5 years for quality and production records ‘

QP-27/5 Internal audit

Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
Done once per year at October ,

The audit plan take the previous audit result by statistical analysis of # of CAR’s form

Check internal audit done for production (clean room , sterilizer , extrusion and printing) at
date 20/10/2016 , 5 CAR’s , CAPA taken and closed ,
Check the internal audit at quality control , at 21/10/2016 , 0 CAR ,
Check the internal audit at quality assurance , at 22/10/2016 , 0 CAR ,
Check the internal audit at technical file and regulatory requirements , at 23/10/2016 , 0
CAR ,
Check the internal audit at sales , at 24/10/2016 , 0 CAR ,
Check the internal audit at purchasing , at 25/10/2016 , 0 CAR ,
Check the internal audit at maintenance , at 26/10/2016 , 1 CAR

Internal auditor Mohamed Elmorsy , ISO 9001:2008 lead auditor certified from SGS ,
certificate # SGS/P/12414
QP-07/5 Management review
Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
Done at 10/11/2016 , All manager attend
 Inputs discussed
Check the internal audit , 6 CAR’ all them closed and must take action toward the hygiene
control ,
Check the new and revised regulatory , update QMS to comply with ISO 13485:2016 and
new directive version ,
Process performance , check histogram and Pareto analysis for all non-conformities and
productivity and efficiency of 2016 , result was the productivity 98% more than limit 96%
and the efficiency was 93% and limit was 92%

Check the outputs , e.g. hire new QA specialist , new package machine for IV set ,
upgrade the CR epoxy , all outputs have action plan

QP-06/5 Quality objectives

Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
Check objective of year 2016

 Produce 600,000 BL , 650,000 FN with different designs with IDP not less than
98%
 Zero recall and maximum non related complaints by increase and update IPS
techniques and method for assembly process ,Assembly process update by
ergonomics and method
 Reduce the qty of non-movement items and old components and PVC tube
 Produce 1,250,000 pieces IV set & 15,000 EGYVAC for local market

Millstones and action plan with resources attached per each objectives

QP-28/5 Control of non-conforming product and corrective and preventive action

Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
Total # of NCN per 2016 was 18
QP-29/5
Issue date Check NCN # 002/16 , date 13/01/2016 , the tube during assembly didn’t reach to the
15/10/2016 end point inside the plastic components , in bloodline , CAPA taken to increase the
Version 5 training and follow up for new labor and closed

Check NCN 008/16 , date 15/04/2016 , was some foreign materials inside the package
of finish product during final inspection , CAPA taken to increase the cleaning process
of tables and package machine , closed

Check NCN # 020/16 date 19/10/2016 , error in number of finish goods during in
process inspection of packing process , CAPA taken to improve the awareness of
packing labor and fix method for packing to prevent error in number , closed

Check the data analysis for NCN , done per each batch and per each year
QP-20/5 Contract Review/Orders/Sales & Marketing /Finance
Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
Check invoice # EGF-2016-01819 , date 28/04/2016 , for sterilization service ,
customer was EIBCIO co

Check invoice # EGF-2016-01830 , date 15/02/2016 , for sterilization service ,

customer was Enteplin co
 Check invoice # EGF-2016-01823 , date 13/03/2016 , for sterilization service ,
customer was Enteplin co

Check invoice # EGF-2016-01462 , date 31/03/2016 , for Fistula needle 16G , BN

10/16B,qty 18,250 , customer was Egyptian group for import and export

Check invoice # EGF-2016-01886 , date 03/05/2016 , for bloodline Fresenius , BN

16/16N,qty 21,950 , customer was Egyptian group for import and export

Check invoice # EGF-2016-03550 , date 31/07/2016 , for Fistula needle 16G , BN

28/16B ,qty 11,500 , customer was Egyptian group for import and export

Check invoice # EGF-2016-04779 , date 10/10/2016 , for Fistula needle 16G , BN

38/16B ,qty 21,500 , customer was Egyptian group for import and export

QP-17/5 Purchasing and supplier evaluation

Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
Check approved supplier list

Check PO’ for different supplier as below

 Check PO # 1008-1 , date 16/10/2016 , supplier was Cairo for production of

package material co. , item as carton 3 layer 50x35x21 , qty 6,500 ,
 Check supplier evaluation and invoice ,

 Check PO 799-1 , date 20/03/2016 , supplier was Modenplast , item was PVC
SH60 , qty 5,500 , check supplier evaluation ,

 Check PO 928-1 , date 10/07/2016 , supplier was BAIN , item (plastic

components) e.g. vented spike , qty70,000 , check supplier evaluation ,

 Check PO 841-1 , date 04/05/2016 , supplier plastic co , item was PE bag for
IV set 20x9 , qty 50 kg , CAR no supplier evaluation for Plastit co

QMS certificate of critical suppliers :-

Bioteque , Taiwan , supplier bloodline and fistula needle plastic components , ISO
13485:2012 from DNV , certificate # Certificate No. 91617-2011-CE-RGC-NA 3.0
Expire at date 25 January 2021

BAIN , China , supplier bloodline and fistula needle plastic components , ISO
13485:2012 , TUV , certificate # 60101337001 , expiry date 14/05/2019

Modenplast , Italy , supplier medical PVC compound , ISO 9001:2008 , TUV ,

certificate # 501004205 , expire date 04/06/2017

Check data analysis of supplier evaluation at year 2016

QP-18/5 Customer feed back

Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
 The survey done for 10 customer in haemodialysis field and 5 in infusion set and wound
suction device

Check at Egypt air hospital , haemodialysis center ,

Check at El Maady Military hospital , haemodialysis center
Check at El Khalifa Elmamoun hospital ,
Check at Demerdash university for IV set and wound suction device,

evaluation range from good to very good

Check data analysis done and actions taken to reduce the delivery time and price

QP-18/5 Customer complaints

Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
1 customer complaint in 2016 , #01/16 , date 15/09/2016 ,
related to B Braun bloodline line BN 35/16B ,
complaint was the big clamp not close well ,
investigation done inside the factory by review batch file , retain samples and clamp test
then visit the hospital ,
root cause was the clamp not close well because the clamp is regular clamp and needed
to be close to the end point to prevent blood flow , carry out training for nurse in hospital
and take preventive action to use on off clamp instead of regular clamp and close

QP-12/5 HR
Issue date
15/10/2016 The procedure implemented effectively ,in place and in use
Version 5
Check the organization chart 2016 ,

Check job description of :-

 Production manager , Hamada Sharaf

 Quality control supervisor , Ahmed Gamal
 Maintenance supervisor , Hossam Yahia
 Sterilizer supervisor , Sabry Saed

Check training plan QP-12-F01/5 , 5 training courses

Check training course on ISO 13485:2012 , conducted at 15 to 20 /09/2016 , attendance

was 2 , e.g. Dina Waheed , check evaluation card for course and training card of here

Check training course of environmental control and hygiene of CR labor , attendance was
50 , done from July to Septmebr /2016
e.g. Ahmed Saber , Doaa Beshaty , Hossam Yahia , Bassant Mohamed and El Sayed
Abdel Aziz , check the training cards and course evaluation

check training card of preventive maintenance of compressor , done at 15/03/2016

,attendance was 1 maintenance technician , Hossam Yahia , check training card and
course evaluation

QP-14/5 Maintenance and Infrastructure

Issue date
15/10/2016 The procedure and preventive maintenance WI’s implemented effectively ,in place and in
Version 5 use
 Check preventive maintenance plan of year 2016 ,

Check preventive maintenance if below machines

 Check preventive maintenance of sterilizer machine , done on monthly basis ,

check at June and Feb /2016,

 Check preventive maintenance of leakage testers , done on weekly basis , checi

at week 46/16 , 20/16 and 35/16,

 Check preventive maintenance of package machine , done on monthly basis ,

check at May and October ,

 Check preventive maintenance of HVAC machine , done each 3 months , HEPA

filter H13 , changed once per year last time was 19/08/2016 , calibration
certificates of filters attached ,

 Check preventive maintenance of drip chamber assembly machine , done on a

monthly basis m check at Jan and November

 Check preventive maintenance of EG Cart and bag filling machine , done on a

monthly basis check at July and September

Check sudden maintenance done

See below examples

 At date 14/11/2016 , deviation was bad printing for bloodline , action taken to
adjust the qty of ink used in printing of paper , closed
 At date 15/05/2016 , CR gowning door not closed well , action taken to replace
the door
 At date 01/12/2015 , the forklift used in warehouse didn’t work , action taken to
repair the hydraulic of it and closed

Check infrastructure plan of year 2016 ,

At 15/01/2016 , action taken to replace the CR epoxy

QP-13/5 Production planning and Processes Control

Issue date
15/10/2016 Visit clean room of assembly
Version 5  Gowning room and change room ,
 disinfectant alcohol 70% used for hands disinfection
 Coats for labor ,
 Product in clean room bloodline Fresenius with heparin , batch # 46/16B
 Pressure gauge between CR and change read 11 pa , code DP05 , calibrated
sticker attached expire at 05/09/2017
 Temperature was 22 c and humidity 45% within limits
 6 leakage tester used for test 100% from bloodline
 1 package machine ,
 3 sealing machine ,

Visit extrusion room

 Gowning room and change room ,
 disinfectant alcohol 70% used for hands disinfection
 Coats for labor
  PVC tube 4.5x6.8x1000 mm batch number BN 46/16.1
 Go no go

Visit sterilizer unit

 Cycle # 320/16 ,
 WI ‘s available QP-13-ST-03/5 with drawings for BI’s distribution

Visit clean room of EG cart and bi bag (new products)

 Gowning room and change room
 Stopped

QP-22/5 Stores
Issue date
15/10/2016 Visit raw material and finish goods warehouse
Version 5
Procedure QP-23/5 for handling and preservation
QP-23/5 & QP-22/5 for identification
Issue date
15/10/2016 Check stock card of bloodline drip chamber , Bioteque , Qty 140,000 BN A1586300 BO
Version 5 FIFO , first in first out achieved by stock card and ERP system

All raw materials and finish goods have sticker with greed label for acceptance contain
code , BN and qty per carton

Visit aeration room , temperature was 38 c at audit date , gauge calibrated WHTH05 ,
expire at 05/09/2016 , logbook checked

QP-13/5 QC Lab , Receiving Inspection/Raw materials and finish products

Issue date
15/10/2016 Raw material release
Version 5
MRN # 2724 , date 22/05/2016 , item was butterfly needle , BN A16105 , qty 300,000 ,
supplier Bioteque , check COA physical , visual and microbial test , released

MRN # 2672 , date 09/04/2016 , item was PVC compound , BN 152401 , qty 5,500 ,
supplier Modenplast , check COA of supplier and visual tests , released

MRN # 2590 , date 19/02/2016 , item was LDPE bag 100x70 , BN 01/16 , qty 100 kg,
supplier plastit ,visual tests , released

Finish product release

GTN report # 3430 ,

date 11/07/2016 ,
product was Fresenius with heparin BN 26/16B, qty 3,675 , COA attached contain
physical and microbial tests , released

GTN report # 3406 ,

date 14/06/2016 ,
product was infusion set BN 31/16T, qty 4,100 , COA attached contain physical and
microbial tests , released

GTN report # 3336 ,

date 30/04/2016 ,
product was infusion set BN 16/16B, qty 5,125 , COA attached contain physical and
microbial tests , released
 Bioburden of raw material
 Dialyzer connector blue , BN C165004 , date 11/10/2016 , result was 4 CFU ,
action 25 CFU ,
 Blood filter , BN C164014 , date 03/07/2016 , result was 4 CFU , action 25 CFU ,
 Injection port red , BN B162303 , date 12/05/2016 , result was 3 CFU , action 25
CFU

Finish goods microbial control

 Bioburden For bloodline m BN 38/16B , date 08/09/2016 , result was 6 CFU ,
action limit 40 CFU
 LAL test for the same batch , limit 0.25 EU/ml , result was no gel
 Bioburden For FN16G BN 28/16B , date 20/07/2016 , result was 4 CFU , action
limit 40 CFU
 LAL test for the same batch , limit 0.25 EU/ml , result was no gel
 Bioburden For infusion set BN 23/16B , date 22/06/2016 , result was 2 CFU ,
action limit 40 CFU
 LAL test for the same batch , limit 0.25 EU/ml , result was no gel

QP-15/5 Environmental Controls/Monitoring/Hygiene Control

Issue date
15/10/2016 Bioburden count for clean rooms done once per each 2 weeks
Version 5 Check EG cart clean room count , date 10/07/2016
At machine # 01 , was 9 CFU , limit was 100 CFU
At pass box # 02 , was CFU , limit was 100 CFU
For air G 1 , was 7 CFU , limit 15 CFU
Finger print e.g. Ahmed Gamal 20 CFU , limit 100 CFU

For CR01 of assembly

At date 11/10/2016
Position T 1 , was 38 CFU, limit 100 CFU
Position T 8 , was 42 CFU, limit 100 CFU
Air grill 09 , was 10 CFU , limit 15 CFU
Finger print e.g. Nagawa Mohamed , 13 CFU , limit 100 CFU

For CR01 of assembly

At date 15/09/2016
Position T 10, was 20 CFU, limit 100 CFU
Position T 15 , was 35 CFU, limit 100 CFU
Air grill 20 , was 08 CFU , limit 15 CFU
Finger print e.g. Mosaad Mohamed , 20 CFU , limit 100 CFU

For CR01 of assembly

At date 18/05/2016
Position T 03, was 18 CFU, limit 100 CFU
Position T 05 , was 15 CFU, limit 100 CFU
Air grill 05 , was 12 CFU , limit 15 CFU
Finger print e.g. Dooa Gaber , 30 CFU , limit 100 CFU

For CR01 of assembly

At date 18/02/2016
Position T 23, was 35 CFU, limit 100 CFU
Position T 07 , was 33 CFU, limit 100 CFU
Air grill 10 , was 05 CFU , limit 15 CFU
Finger print e.g. Ahmed Omar , 40 CFU , limit 100 CFU
QP-25/5 Identification and traceability and batch files
Issue date
15/10/2016 The procedure, WI’s , and test methods implemented effectively ,in place and in use
Version 5
Check batch number 24/16B ,
QP-26/5 Fresenius with heparin bloodline ,
Issue date Qty 16,250 ,
15/10/2016 manufacture date 06/2016 ,
Version 5 Check in process inspection begin at 10/06/2016 and ended at 17/06/2016 ,
Check final inspection and packaging done at 18/06/2016 ,
Check LOT by LOT sheet (statistical analysis of batch) , of product reject was 0
Check package material and label , contain all data and symbols
Check batch traceability record done by ERB system e.g. blood filter supplier Bioteque ,
BN 201601043022 ,
Check histogram charts of PVC tube used
Check sterilization cycles # 145/16 , 147/16 , 148/16 ,, 149/16 and 150/16

Check batch number 20/16B ,

fistula needle ,
Qty 25,000
manufacture date 05/2016
Check in process inspection begin at 13/05/2016 and ended at 20/05/2016
Check final inspection and packaging done at 22/05/2016
Check LOT by LOT sheet (statistical analysis of batch) , of product reject was 0
Check package material and label , contain all data and symbols
Check batch traceability record done by ERB system
e.g. fistula needl top part Bioteque , BN A185216-BO
Check histogram charts of PVC tube used
Check sterilization cycles # 130/16 , 128/16 and 133/16

Check batch number 21/16B ,

Wound suction device Size 18 ,
Qty 3,000
manufacture date 05/2016
Check in process inspection begin at 26/05/2016 and ended at 30/05/2016
Check final inspection and packaging done at 02/06/2016
Check LOT by LOT sheet (statistical analysis of batch) , of product reject was 0
Check package material and label , contain all data and symbols
Check batch traceability record done by ERB system
e.g. bottle , supplier Ultra co , BN 15620/16
Check histogram charts of PVC tube used
Check sterilization cycles # 126/16 , 130/16 , 128/16 and 138/16

Check batch number 46/16B ,

Gambro with heparin ,
Qty 20,500
manufacture date 10/2016
Check in process inspection begin at 11/10/2016 and ended at 15/10/2016
Check final inspection and packaging done at 16/10/2016
Check LOT by LOT sheet (statistical analysis of batch) , of product reject was 0
Check package material and label , contain all data and symbols
Check batch traceability record done by ERB system
e.g. dialyzer connector cap , C164002-BO
Check histogram charts of PVC tube used
Check sterilization cycles # 214/16 , 215/16 , 216/16 and 217/16
 And check also batches 44/16 , 05/16 , 17/16 and 25/16

WI ETO Sterilization routine control

QP-13-ST-
03/5 The procedure, WI’s , and test methods implemented effectively ,in place and in use
Issued at
15/10/2016 See below table :-
Version # 05
Cycle # Date Items Incubation result 14 Aeration
QCT007- BI’s end date
Biological Lot # of BI’ G192
indicator 034/2016 17/02/2016 Bloodline Fresenius -ve 21/02
verification BN 07/16B
test & Qty 4125
QCT008- 053/16 03/03/2016 Infusion set -ve 06/03
Biological BN 09/10S, qty
media 46,000
preparation 083/16 02/04/2016 Bloodline Fresenius -ve 06/04
test BN 13/16B
Qty 5125
149/16 20/06/2016 Fistula needle16g -ve 26/06
BN 24/16 , qty
13,000
206/16 21/09/2016 Fistula needle 16G -ve 26/09
38/16S , 5250
229/16 10/11/2016 Fresenius HDF , BN -ve 16/11
45/16B, qty 1140

QP-29/5 Sterilizer validation

Issue date
15/10/2016 As previous validation of year 2015
Version 5 Check risk assessment process for sterilization form # QP-19-ST-15 /2
WI
QP-13-ST-
02/5
15/10/2016
Version # 05
QP-24/5 Calibration
Issue date
15/10/2016 Done by 3rd party lab EES co ,
Version 5
Check calibration of DP of clean room , code C11/P , certificate # 010-093-2016 , expire
date 04/09/2017 ,

Check calibration of temperature gauge of water path , code Q04/T , certificate # 015-093-
2016 , expire date 04/09/2017 ,

Check calibration of pressure gauge of autoclave , code Q05/P , certificate # 018-093-

2016 , expire date 04/09/2017 ,

Check calibration of leakage tester , code C05/P , certificate # 019-093-2016 , expire date
04/09/2017 ,

Check calibration of leakage tester , code C06/P , certificate # 021-093-2016 , expire date
04/09/2017 ,
 Check calibration of steam pressure gauge of sterilizer , code G01/11 , certificate # 024-
093-2016 , expire date 04/09/2017 ,

Check calibration of chamber pressure gauge of sterilizer , code G01/12 , certificate #

025-093-2016 , expire date 04/09/2017 ,

Check calibration of digital balance of sterilizer , code G01/15, certificate # 026-093-2016 ,

expire date 04/09/2017 ,

Check calibration of go no go of extrusion, code E05/2, certificate # 045-093-2016 , expire

date 5/09/2017 ,

Check calibration of thermo hygrometer of clean room, code TRH05, certificate # 056-
093-2016 , expire date 06/09/2017 ,

QP-29/5 Clean room validation

Issue date
15/10/2016 Done by Ietqan 3rd party lab , accredited ISO 17025:2012 from Egyptian accreditation
Version 5 council , certificate # 315002A , expire date 28/02/2020

Check CR 01 validation report # 2016-VC-22 , at 24/09/2016

Clean room volume 280 m2

Check particle count at 0.5 was 2,033,963 and at 5 was 10,594

Air change rate was 33

Check CR 02 validation report # 2016-VC-20 , 25/07/2016

Clean room volume 50 m2

Check particle count at 0.5 was 1,030,00 and at 5 was 5,593

Air change rate was 22

Check particle counter calibration certificate , Lighthouse , SN 150588973 , certificate

# 001P-288-2016 , expire date 11/01/2017