Professional Documents
Culture Documents
None
Check quality policy signed from plant director Dr. Azza Rostom ,
communicated and understood
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
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
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 PO 799-1 , date 20/03/2016 , supplier was Modenplast , item was PVC
SH60 , qty 5,500 , 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
BAIN , China , supplier bloodline and fistula needle plastic components , ISO
13485:2012 , TUV , certificate # 60101337001 , expiry date 14/05/2019
Check data analysis done and actions taken to reduce the delivery time and price
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 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
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
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
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
Check calibration of temperature gauge of water path , code Q04/T , certificate # 015-093-
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 thermo hygrometer of clean room, code TRH05, certificate # 056-
093-2016 , expire date 06/09/2017 ,