WAR-015 Warehouse Processing Issues, Returns and Rejects

1. Issues to Production for a Batch Production Number

1.1. Production will request for required components (after consulting the Bill of Materials for the specific product code) as needed according to production schedules.  Production will issue a Material Transfer Order Form (Form-055), assign a transfer order number in a format of LX-YYYYYY.

Where,

L = Line

X = Line number

YYYYYY is a consecutive number starting at the beginning of the year form 000001 and ends up in that year.

1.2. Fill out the required (Left side of the form) sections and send to warehouse allowing a minimum of four hours or the specified time written on the form between the time of request and the time delivery is required.

There are three (3) areas from which the material can be obtained to fill the production requirements of the components:

CR   COOL ROOM – WAREHOUSE

FS   FLAMMABLE STORE – WAREHOUSE.

BS   BULK STORE – WAREHOUSE

The reject cage will be used only In case of a reject component to store for some time.

RC     REJECT CAGE – WAREHOUSE

The Quarantine area will be used only for

Storing incoming goods up to release by Laboratory

Storing Finished goods, completely separated from incoming goods, up to the release for distribution by Quality Assurance.

QIG      QUARANTINE – (for in-coming goods) RECEIVING WAREHOUSE

QFG     QUARANTINE – (for finished goods) DISTRIBUTION WAREHOUSE

There are three (3) areas of production in which materials will be transferred to:

PW1     Production WIP area 1

PW2     Production WIP area 2

IP         Interim production staging area.

1.3. Before you start an Issue

1.3.1. At the beginning of your shift consult the warehouse operator of the previous shift for any issues or problems that may have to be dealt with.

1.3.2. Collect the Material Transfer Order Form from production. Print out copies of Issue for Production Form/s (Form-030) one for each of the pallet involved.

1.3.3. Copy the following items on the Issue for Production Form from the Material Transfer Order Form. Clip both the Issue form and Transfer Order and placed them in the “issue tray” of the Receiving Warehouse Office in order of time requested to collect by available warehouse operator.

1.3.3.1. TIME and DATE to be delivered.

1.3.3.2. NAME of the person requesting the material.

1.3.3.3. LINE or AREA that the material is required.

1.3.3.4. BPN, Pallet no. and Quantity.

1.3.4. Only one Issue must be assembled at a time.  Collect the top MTO and Issue For Production Form to assemble.

1.3.5. Think about how the complete Issue should look.  With this in mind, select the pallet size that is most appropriate for the Issue, and pick each material in an order that will cause the complete issue to be most stable, e.g. Heavy, even goods on the bottom of a pallet, lighter goods on top.  The company ID labels should always face outwards for easy checking.

Note: Ensure that the pallet used has been designated for use in Production.

Place a slip sheet on top of each empty pallet and load the goods on top of the slip-sheet.

1.4. Picking an issue

1.4.1. The Material Transfer Order will contain the following information for each line:

Production to fill up: Transfer Order Number, Created time and date, Created by, BPN, Process line, Material code, Description, Lab. Batch number, Expiry date and Target Qty.

Warehouse to fill up: Assembler Name, Sign and Date; Assembler count, Source and Destination Storage type and Storage Bin, Reference GRS number. (Write Dispensary Booth number in place of storage bin for transferring raw material to be dispensed by the Dispensary)

The source “Storage Type” and “Storage Bin” will provide the location and point from which the material is to be picked. The destination “Storage Type” and “Storage Bin” will provide the location and point to which the material will be transferred. See WAR-030 about the Storage Types and Storage bins in the warehouse.

Note: For Raw material dispensing, Source and Destination Storage type will be form Bulk Store (BS) to Dispensary (DS) to Production WIP area (PW).

1.3.2. Warehouse staff to ensure that the source pallets are marked with Released sticker on them by the Laboratory.

1.3.3. Use the forklift to retrieve the pallet located in the storage bin.

1.4.4. Inspect each material to ensure the information on the goods corresponds to the Material code, Description and Laboratory Batch no. written on the Transfer Order Form. Take enough material from the source pallet to at least cover the quantity required for the issue. NEVER undersupply production with materials, unless Production has agreed.

1.4.5. Using a Black marker, write the quantity removed from the source pallet on the “ISSUE” column of the Bin Sheet (Form-020).  Then calculate the quantity remaining on the pallet and write the new quantity in the ‘BALANCE“ column of the bin sheet.  The updated Bin sheet is then placed back onto pallet.

1.4.6. Write down the quantity taken and pallet no. on the Issue for Production Form (Form-030) using a Blue or Black pen. Leave the checked section blank for authorised person to check and Initial.

1.4.7. Put the remaining goods back into the original location.

1.4.8. Repeat steps 1.4.1. to 1.4.7. until the Transfer Order Form is complete.

1.4.9. Ensure the complete issue is very stable and is not overhanging the slip-sheet or pallet. Note: Ensure all goods are free of dust and dirt, before sending into production.

1.4.10. When the requested Issue have been completed for a line, the component assembler (Warehouse Store person) will give a count, write down the source and destination Storage type and Storage bin, Reference GRS number of each material collected form the warehouse GRS filing cabinet. The number of pallets used to complete the issue is also added next to the initials on the Transfer Orders.

1.4.11. An “Issue For Production” form (Form-030) is fully filled up including the Process Line, Person who requested goods through the Transfer Order, Date, Time materials required, Batch Production Number, and the Number of the Pallet/s, (e.g. 1 of 3.).

1.4.12. Every Issue is to be checked by an authorised Store person before delivery into production.  The assembler will sign and date at the top section of TO and sign in the “Assembled By” section. The “checker” will sign and initial on the “Checked By” section of the TO and write a “Y” next to CHECKED on the “Issue for Production Form” with a black marker. The authorized checker will then attach the Issue for Production Form/s on all the pallets involved in the issue.

1.4.13. Place the completed Transfer Order into the “Issues to be checked and confirmed” tray.  One copy of the completed Transfer Order goes with the goods. The original Transfer Order will be kept in the warehouse for filing. These MTO will be needed for periodic inventory count. Issue For Production form will go with the pallets. Bin sheet will stay with the sourced pallet/s.

Note: All raw materials will be dispensed through Intermediate Bulk Containers (IBC) by the Dispensary. (i.e. imported bulk tablets)

2. Issues of Production Consumables (Non Component Goods)

Production consumables are materials that are used in the production process, but not directly with a particular BPN, such as cleaning cloths, sterile latex gloves, cleaning solutions, and many more. Non component goods are transferred to the production according to WAR-005 section 2.2.

3. Materials Return From Production

This is a brief rundown to what Production Operators do for the return of materials:

3.1. When returning Material/s from Production to Warehouse (PW-BS), or from Production to Interim production area (PW-IP), an accurate count of the amount returned should be obtained.  Any partial boxes to be returned should carry a ‘PARTIAL’ sticker.

3.2. All component rolls i.e. PVC film, unprinted foil, shrink films and shippers must be placed in a secondary container, i.e. a clear sealed plastic bag and identified with a ‘PARTIAL’ sticker identifying Material code, Lab. Batch No. and quantity.

If there is any leftover raw material/component after finishing a batch, it is to be either returned to the Warehouse (PW – BS), or should be moved to Interim production area (PW to IP).

*If the leftover material/s (unprinted packaging components) are going to be used on another BPN that is coming up shortly on the production schedules, (eg PVC film, foils, shrink films and shippers) an INTERIM MOVEMENT (PW to IP) should be done.

Or alternatively

*If the leftover material/s are no longer required for the current BPN (eg Leaflets, Cartons, printed foil) a return to warehouse (PW to BS) movement is done.

*Note: Raw materials (Actives or excipients) once dispensed into IBC bins should not be returned except under special circumstances and appropriate authorization.

Production operator will issue a Material Transfer Order – Return Form (Form-070) and fill up the Original Transfer Order No. on the form. Assign a Return Transfer Order No. in a format of RETLX.YYYYYY, where RET stands for Return, L for Line, X for Line number, YYYYYY is the original Transfer Order Number.

3.3. Production operator has to fill up the Process line, Material code. Description, Lab. Batch no, returned qty. and Reference GRS number/s of the returned materials. Operator then sign and date the TO (created by-left side). An authorized production operator will check the pallet to be returned and sign at the bottom.

The TO-Return is than be attached at the front of pallet to be returned. All products must have easy-to-read labels, e.g. carton labels facing out.  Attach a Return to Bulk Store Form (Form-025) on the pallet and send to the Warehouse.

Note:
Never place any returns on top of finished goods pallets as this could result in a mix-up and breach of GMP.

4. Receipt of Production Returns by Warehouse

4.1. All returns at the Warehouse must be processed within 24 hours. When sent to the warehouse returns are placed in the marked area near the bulk store of warehouse until paperwork is complete.

4.2. Warehouse operator will check the code, batch and quantity of the goods against the TO- Return. If the details are correct, proceed.  If not, contact the production person who processed the returns.  If contact cannot be made, contact process Manager of that area to deal with the discrepancies.  If this cannot be resolved, raise a DR (See QMS-035).

4.3. Warehouse operator will fill up the right side of the TO- Return Form including operator count, source and destination storage type and storage bin, reference GRS number/s collected from original Material Transfer Order. One authorized warehouse staff will check the return and complete the TO-Return by signing the form. The operator will than transfer the returned good to its original Storage bin in such a way that the next order will be continued with the returned material itself. The original Bin Sheet (Form-020) attached to the pallet will be adjusted by increasing the returned quantity. This is important for periodic reconciliation of stocks.

4.4. The Material Transfer Order – Return Form will be kept in the warehouse office for future reference and stock adjustment.

5. Material Rejects From Production

5.1. Following an unfavourable Deviation investigation (By use of a DR) Production can reject raw material that was issued for certain BPN. In such cases Production Operator will inform the Warehouse that a certain material code, Lab. Batch # and Quantity is getting rejected.  They will have to present the Warehouse with the completed DR and all the relevant information.

5.2. Production operator will issue a Material Transfer Order – Reject Form (Form-065) and fill up the Deviation Report no (on the right side) and Original Transfer Order no. Production Operator has to assign a Transfer Order Reject No. in a format of REJLX.YYYY, where REJ stands for Reject, L for Line, X for Line number, YYYYYY is the original Transfer Order Number. Operator will fill up Process line, Material code. Description, Lab. Batch no, rejected qty. and then sign and date the TO (left side). An authorized production operator will check the pallet to be rejected and sign.

5.3. Production operator will print out “REJECTED” stickers (Form-095) one for each bag/container/shipper and attached the stickers on to them in the front so that the stickers could be easily visible by the warehouse operators.

5.4. The MTO-Reject form and a copy of DR are placed into an envelop and than be attached at the front of rejected pallet. All products must have easy-to-read labels and stickers, e.g. carton labels facing out. Attach a Warehouse Information Form (Form-015) collected from the purchasing department with the rejected pallet which will describe the warehouse operator what to do with the rejected goods.

6. Receipt of Production Rejects by Warehouse

6.1. All production raw material/component rejects at the Warehouse must be kept into REJECT CAGE- Warehouse area until all paperwork is complete and rejects will be sent as instructed in the Warehouse Information Form.

6.2. Warehouse operator will check the material code, batch and quantity of the goods against the TO- Reject. If the details are correct, proceed.  If not, contact the production person who processed the rejects.

6.3. Warehouse operator will fill up the right side of the TO-Reject Form including operator count, source and destination storage type and storage bin (destination storage type will be always Reject Cage for the Rejected raw material/component), reference GRS number. One authorized warehouse staff will check the reject and complete the TO-Reject by signing the form.

6.4. The attached DR will be completed by finishing the management response task created for the warehouse manager and send to QA/purchasing department.

6.5. The Material Transfer Order – Reject Form will be kept in the warehouse office for future reference and stock adjustment

7. Rejects – Incoming Raw Materials

7.1. If the incoming raw materials does not meet the requirement a DR should be raised by warehouse and notify purchasing the situation. Separate the damaged goods from the delivery and record the items, vendor batch numbers and quantities of goods damaged.

7.2. The raw material is temporarily kept in the Reject cage (RC).

7.3. Mark on the incoming invoice: The items, vendor batch and quantity of damaged goods.

7.4. Contact Purchasing, telling them the invoice number, Purchase order number, vendor, items and quantity damaged.

7.5. Complete a Deviation Report (DR) for each individual product separately being rejected.  Note: Your DR details must equal your rejected stock details.

7.6. Purchasing will send an Warehouse Information Form after having a decision (Form-015) stating where and how to send the goods again or destroy.

8. Picking Rejected Stock for Return

8.1. Warehouse staff has to pick up a rejected stock for return to supplier from Quarantine area, if the stock is rejected by the laboratory after testing and followed by a decision through a Deviation Report System.

8.2. Purchasing team will print and fill up a Warehouse Information Form (Form-015), which will inform the warehouse staff what should happen with the stock (Return or Destroy).

8.3. Once the stock has been picked from the Quarantine location, the Component Assembler must check the stock for correct material, batch and quantity and write his name, sign and date. A second warehouse authorised person has to check the stock is correct and write name, sign and date.

8.4. For a return decision rejected goods will be sent to supplier’s address provided by the form. For a Destroy decision follow EHS-005 for Waste or Reject removal process.

8.5. One copy of completed Warehouse Information Form (Form-015) will be sent to Purchasing team and the original will be kept in the Warehouse for filing.

9. Rejects – Production Finished Goods

9.1. If the finished Goods has come from Production and appeared to be damaged – before coming into the Warehouse – notify that Process Area Manager straight away – as they maybe able to rework the Batch and raise a DR to reflect the situation.

9.2. If the damage has happened within the Warehouse area – then raise a DR within warehouse.

9.3. Write down the code, BPN and quantity of all items that are to be rejected and have another operator check them to ensure all the damage is recorded.

9.4. Firstly the Deviation Report (DR) must be completed for each individual product separately being rejected according to SOP QMS-035. Please ensure that the Finish Goods being rejected have the correct details i.e. Product code, BPN and pallet number on the DR.
Note: DR details must equal your rejected stock details.

9.5. Attach a printed copy of the DR to the pallet/s.

9.6. Return the pallet/s involved into the Finished Goods Quarantine (QFG) area until a decision will made by QA Management.

10. Summary of Changes