Subject Issue date: 01/01/2010

Product Identification, Traceability and Issue/Modification: 1/5

Labelling Modification date: 26/04/2020
No.: QP-024 Page: 1 of 7

1- Purpose:
This procedure is to:
1-1 Establishing a system for the products identification and traceability as well as labeling of the
different items during their entire production stages until their deliverance to the customer.
1-2 It endeavors the following:
1-2-1 Preventing mixing-up during processing.
1-2-2 Enabling substandard products to be recalled from the marketplace.

2- Scope of Application:
This Procedure shall be applied to all Traceability and Labelling Activities of Incoming Material /
intermediate product (Injection / Extrusion Products) / Finished product in SILVER MED and all
inspection & test activities of SILVER MED.
3- Responsibility:
3-1 Quality and Production managers are responsible for ensuring that all items and products are
identified according to the requirements of this procedure.

3-2 Warehouse keeper are responsible for the implementation to identify the codes of materials/Products
stored in SILVER MED warehouses.

3-3 Acceptance status shall be the Responsibility of the Quality Control supervisor and his Team to
identify the Inspection & Test status of Products during the manufacturing processes.

4- Abbreviations & Definitions

4-1 QC: Quality Control
4-2 MRB: Material Review Board

5- Work Instructions
None.
6- Forms and Enclosures
6-1 QF-024-001 : Finished product Batch traceability Record
6-2 QF-024-002 : Extrusion Batch traceability Record
6-3 QF-024-003 : In Process Batch traceability Product Record
6-4 QF-024-004 : Batch file index
6-5 QF-024-005: Accepted Items (Green Card)
6-6 QF-024-006: Rejected Items ( Red Card )
6-7 QF-024-007 : Under Inspection Items (White Card)
6-8 QF-024-008: Hold (Yellow card)
6-9 QF-024-009 : Coding form
6-10 QF-024-010 : Product Bill of material Design
6-11 QF-024-011 : Art Work Design
6-12 QF-024-012 : ‫بيانات تشغيله‬
6-13 QF-024-013 : Tube Identification
 Subject Issue date: 01/01/2010
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Labelling Modification date: 26/04/2020
No.: QP-024 Page: 2 of 7

7- Procedure:
7-1 Product Traceability Coding
Both the Purchased Incoming Materials and the Intermediate Products (during the production
stages) together with the Finished Products are identified by means of a unique code number as well
as a coding form "QF-024-009".

7-1-1 Traceability code of finished Product or subassembly is formed according to following

methodology WXXYYZZ
Item Type Item Type Product (XX) Sterility (YY) Serial Number (ZZ)
Refer to
(W)
Finished F Blood line(BL) Sterile (01) Blood line (start-50)
Product Non sterile (02)
Bulk B Fistula Needle(FN) Fistula needle (start-60)
(subassembly)
Infusion(In) Infusion (start 70)

Nelaton (Ne) Nelaton (80)

7-1-2 For the Raw material,, Tubes, Components, and packing materials will be coded according to
following method (VWWXYYZZZ)
Item Type Item type Product Model of (YY) Serial
Refer to (WW) Product(X) Number
(V) (ZZZ)
Raw Material R BL, FN, In, BL Material nature Serial
(resin, Ne and GE (U: Universal, Resin(RS) number
compounds, (general ) G: Gambro, Compounds (CP)
Chemicals,) F: Fresenius, Chemical (Ch.)
Tubes T BL, FN, In, B: B. Braun,.) Represent outer Tube Length
Ne diameter of tube

FN (16, 17, ...)

 Subject Issue date: 01/01/2010
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Labelling Modification date: 26/04/2020
No.: QP-024 Page: 3 of 7

Components C BL, FN, In, In(22, 21, 20, Components Serial

Ne 18, 17, 16, 15) material number
PP (poly
Ne (06, 08, 10, propylene)
12, 14, …) PV(Polyvinylchloride
)
PC (polycarbonate)
HD (high density)
LD (low density)
SR (silicon
rubber)….

Packing as P BL, FN, In, Packing type Serial

(Labels, Ne Labels (LB) number
carton boxes, Carton boxes(CB)
outers, PE Polyethylene
bags, carton bag(PB)
separator, Stickers (ST)
carton nest,
…….
Blister films
and Stickers)

7-2 Bill of Material:

For each product, there is a bill of material which contains data for:
Bill of Material which contains materials, quantity and for each product.
Product Bill of material Design form (QF-024-010) which contains the design of each product.

7-3 Traceability during production Process

After completion of the Produced lot for Intermediate product "Control Area products" QC extrusion
supervisor complete "Extrusion Batch Traceability form no. (QF-024-002)"and collect the Batch files
contents and send all at the end of lot every month for all produced tubes during that month
And in case of Finished product "Clean Area products" QC inspector start to fill data of "In process
Batch Traceability form no. (QF-024-003)" when starting the assembly of work order and send it daily
to QC section head for revision and signed it then to be sent to Quality Lab for archiving by the Batch
file responsible and once the lot completed he will finalize "finished Product Batch traceability
"QF-024-001" and to be delivered to batch file responsible to complete the needed records of batch
file and sign it.
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Labelling Modification date: 26/04/2020
No.: QP-024 Page: 4 of 7

7-4 Identification products or items during Production

- All items either incoming material , Intermediate ,or finished products to be identified during
the stages of receiving inspection , In process ,or out going by identification Cards as following:
QF-024-005 Accepted Items (Green Card)
QF-024-006 Rejected Items ( Red Card )
QF-024-007 Under Inspection Items (White Card)
QF-024-008 Hold (Yellow card)
- The responsible for identification is the inspector of Quality control and nobody remove or
scrap this card rather than quality control inspectors.
- For under inspection cards QF-024-007 production supervisor can use it in case of
unavailability of QC inspector
- For Hold identification QF-024-008 will be used for the items that need action for a long time
either in warehouse or production area.
QF-024-012- )‫ (بيانات تشغيله‬This form used to identify the assembled intermediate or final
assembly inside clean rooms and control area as the operator fill this form by identifying section
name, lot number, ID number, Code, type of produced item, the stage of production , quantity ,
Operator, labor name, date, shift data .
7-5 Content of Labelling
The label must bear the following particulars:

1- the manufacturer data (Name& Address& Phone& Fax& Website)

2- Lot number (each month) &Batch number(each 3 months)

3-Code of the product
4- production date and expire date
5- if the product is sterile indicate this on the label and indicate the method of sterilization
6-CE mark
7-serial number
8-if the device is single use indicate this on the label
9- any special storage and/or handling conditions
10- any special operating instructions;
11- any warnings and/or precautions to take
12-“intended purpose” means the use for which the device is intended according to
the data supplied by the manufacturer on the labelling, in the instructions and/or in
Promotional material;’ If the intended purpose of the device is not obvious to the user, the
manufacturer must clearly state it on the label and in the instructions for use.
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13- Authorized representative(Name& Address& Phone& Fax and email)

14- “clinical data” means the safety and/or performance information that is generated
For the use of a device

7-6 CE mark preparation

To be affixed CE Mark in the following:
1- Silver med Carton
2- HDPE Packing
The CE conformity marking shall consist of the initials ‘CE’ taking the following
form: MDD 93/42/EEC consolidated 2007
3- The various components of the CE marking must have substantially the same
vertical dimension, Which may not be less than 5 mm.
4- This minimum dimension may be waived for small-scale devices
5- CE mark is affixing on packing and carton of finished product and approved from plant
manager & quality manger and purchasing manager Through Design and development
request (QP-058).

7-7 Batch file

7-7-1 For each lot of the product (either Intermediate product or Finished product) there is a Batch
file which contains the following Records to facilitate traceability:
7-7-2 All the Final Inspection Records for the concerned batch.
7-7-3 Copy of the label used (filled) signed by the production supervisor.
7-7-4 Sterilization Reports (where applicable) (Form No. QF-021-003).
7-7-5 Batch / Lot traceability Record No.
7-7-6 All the Non Conformance report (Form No. QF-043-001)
7-7-7 Incoming Inspection reports for Incoming Materials if requested (Form No. QF-041-001).
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Labelling Modification date: 26/04/2020
No.: QP-024 Page: 6 of 7

7-7-8 Any Customer Complaint received for the concerned batch (Form No. QF-033-001)
7-7-9 MRB

Note : In case of remaining in process product , it will be allowed to be produced

till 3 days in next month.
Examble lot : 0319 (lot month 3 ) is used until day 3/4/2019

7-8 Design Approval:

Quality Assurance Responsible should prepare the Art work design from No. (QF-024-011)
or each product / Items for approval before mass printing either internally in Sliver Med
or externally by supplier to be ready for production.
8- Reference Documents
8-1 ISO 13485:2016
8-2 ISO 15223: 2015
8-2 Council Directive MDD 93/42/EEC and MDD 2007/47/EC ANNEX I ESSENTIAL Requirements.

- Note 1: In case the products are special for Ministries of Health or defense, Production
responsible stamp the pouches with stamp of ministry of health or ministry of defense
and Production supervisor put letter (A) on the sticker beside the ID of the product ex:
for date 20/6 :20060A
And (A1) in case the pouches inside cartoon aren't stamped by the stamp of ministry of
health or ministry of defense.
- Note 2: In case of Infusion Set if the component used is a (tube connector) Production
supervisor put letter (B) on the sticker beside the ID of the product. If a (flash ball
(Rubber)) Production supervisor put letter (A) on the sticker beside the ID of the
product.
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Labelling Modification date: 26/04/2020
No.: QP-024 Page: 7 of 7

9- Change History:
Issue/ Issue/
Modified
Modification Modification Nature of Modification
pages
Date No.
01/01/2010 First issue according to 13485
1/0 All pages
:2003
22/01/2011 1/1 Change for more details
19/12/2013 1/2 Adding details for daily lot.
27/01/2015 1/3 Change in procedure
27/5/2018 Change according to update
1/4
ISO
26/04/2020 1/5 1) Improvement of the All pages
document to be more
Inclusive and detailing To be
in keeping up with the
current status
2) Modifying procedure
according to new Document
"document control
procedure" No. QP-001)
3) Issuing New forms of
QF-024-005 - Accepted Items (Green Card)
QF-024-006 - Rejected Items ( Red Card )
QF-024-007 - Under Inspection Items (White Card)
QF-024-008 - Hold (Yellow card)
QF-024-009 : Coding form
QF-024-010 : Product Bill of material Design
QF-024-011 : Art Work Design
QF-024-012 : ‫بيانات تشغيله‬

10- Approvals:
Prepared by Approved by Stamp
Name: Name:
Title: Title:
Sign: Sign: