PROC-018 PROCEDURE PURCHASING & RECEIVINGNERIFICATION

Transcription

1 Unit 3, 44 McCauley Street MATRA VILLE NSW 2036 PROC-018 PROCEDURE PURCHASING & RECEIVINGNERIFICATION Prepared by: Date: Position: Checked: Date: Position: J Approved by: Date: CEO The following ATTACHMENTS form part of this document. F023 Purchase Order Requisition Form This revision supersedes all previous revisions. Controlled copy only if stamped with Controlled Copy Stamp and issued with copy number PROC Purchasing & Receiving-Verification.doc Page 1 of 18

2 1. INTRODUCTION 1.1 Purpose of Document To define and control the processes of preparing, issuing Purchase Orders, receiving and inwards inspection 1.2 Purpose of Procedure To ensure that all purchase orders for materials or services clearly specify all the requirements including special verification and certification requirements and the appropriate quality standard where applicable. (This procedure is applicable to purchasing medical devices and is a sub-part of Portland PROC-005 Purchasing, Receiving, Stock control of Product & Dispersal.) To ensure that all goods and services received by the company, (including material received from customers for inclusion in jobs), conform to specified requirements. 1.3 Scope All materials, goods and services purchased or received that have a bearing on quality. It covers following areas: Purchasing Receiving & Inwards Inspection Verifying Customer Supplied Goods Early Release of received goods Petty Cash This procedure does not include preparing purchasing data e.g. Purchase Product Specifications etc. 1.4 Other Documents Referred To Internal References PROC-003 Improvement of System/Product PROC-009 Procedure -Assessing Vendors & Subcontractors PROC-012 Storage, Handling & Transport P-1301 Vimek Procedure - Nonconformances REG-011 Register- Approved Vendors & Subcontractors F023 Purchase Order Requisition Form F001 Multi-purpose Form External References Nil Page 2 of 18

3 1.5 Definitions of Terms Used Subcontractor Vendor Approved subcontractors or vendor MO ocs PO Purchased Product Specification (PPS) CEO CTO A supplier or potential supplier of materials or services to the company to our specification. A supplier or potential supplier of materials or services to the company to their specification. A supplier, vendor or sub-contractor on the approved supplier list Manufacturing order [F020] Operations control sheet [F021] Purchase Order A document that records the major details on a purchased item, e.g. Specification, supplier, PO details, inspection & storage details Chief Executive Officer Chief Technology Officer 1.6 General I Authority The responsibility for the procedure is with the Management Representative, who has the authority to delegate responsibility to other people to carry out the work. Where this Authority has already been delegated, it is noted in paragraphs "" against stages later in this procedure. ) Page 3 of 18

4 2. PROCEDURE Flowchart PREPARING & ISSUING PURCHASE ORDERS Requirement Checking Details No -4 PROC-009 orceo/cto Approval Yse ) Yes '-----< Revising PO? No Receiving & Inwards lnsp'n 2.1 Checking details Manager Authorised Employee Before raising a purchase order in the computer, collect the information set out below. (Purchase Order Requisition Form [F023] can be used to collect the information but is not a requirement to be used or retained). Page 4 of 18

5 PROCEDURE- PURCHASING & RECEIVINGNERIFICATION For general manufacturing parts, information can be found on the work instruction or drawing. If a stock part number is referenced, then refer to its Purchased Product Specification for details. 1. Supplier information Check if vendor or subcontractor is approved and indicate in box. If the supplier is a vendor or sub-contractor that is not yet on the approved vendor/subcontractor list (REG-011 ), the order can only be placed with the prior authorisation of the CEO or CTO. Vendors & Subcontractor should be evaluated for the approved subcontractor list. Refer to PROC Item Descriptions & Quantities Determine: Product(s) to be ordered & stock part number if available Item quantity(s) The description may contain the following additional information if needed: vendor/subcontractor product code precise qualifying details such as type, model, class, grade etc. quotation reference (can be in Your Ref) further description of the product or service being ordered, including references to previous orders if relevant accurately identified specifications to which the product is being ordered and, in particular, the company's or customer supplied drawings identification inspection requirements and acceptable standards (including any requirements for the company or our customer to inspect the material or product prior to despatch from the vendor/subcontractor. Arrangements to be agreed before placing order) any other relevant technical data including requirements for approval or qualification of product, procedures, process equipment and personnel including certification as appropriate the quality management system requirements i.e. numb r. the issue and title of the quality standard {if applicable). NOTE: a) Verification by subcontractor Where verification of the product is to be carried out by the subcontractor, we shall specify the verification specification ana method of product release in the purchasing documents. This will usually require a test certificate or Certificate of Conformance to be supplied with the product. NOTE b) Verification at subcontractor Where we carry out verification at the subcontractors premises, arrangements & records are to be made with the vendor/subcontractor for the conduct of the verification and also inspection/test criteria that must be satisfied for product release. ) 3. Pricing Details All prices are to be checked and written quotes obtained from sub-contractors {the reference can be placed in 'Your Ref) where appropriate. 4. Manufacturing Details Page of 18

6 Note: PORTLAND GROUP QUALITY SYSTEM lot numbers - where applicable if test certificate or heat number required if product to be delivered elsewhere (default is.factory) 5. Accounting Details Obtain General Ledger No. from Accounts listing. Documents or Records to be Produced Purchase Order Requisition Form [F023]. Possible written quotes with MO or Purchase Product Specification (part numbered part) 2.2 Raising purchase orders Manager Purchase orders are raised on the computer using Exchequer and are automatically sequentially numbered. Purchase Orders contain the following minimum information: Vendor/subcontractor name (including address etc) contact and telephone number etc( in Alt Ref) Deliver to details (if needed) Delivery date required Purchase order date lot number - where applicable For each entry line, enter information needed: Item quantity(s) Stock code if applicable Description of Product(s) to be ordered. This will include information in description above. Manufacturing information can be on separate line (use Qty=O in computer) or on each line, as needed especially Lot No.s. Item unit cost(s) Extended item totals(s) GL code. Documents or Records to be Produced Internal computer purchase order 2.3 Approving purchase order ) CEO Page 6 of 18

7 PROCEDURE- PURCHASING & RECEIVINGNERIFICATION Check the adequacy of the purchase requirements. The order is released for printing or faxing via password granted authority within Exchequer or signature on physical PO document for orders over $100. Documents or Records to be Produced Paper copy of purchase order 2.4 Issuing purchase orders Recording & Filing Manager ) Orders may not ordinarily be placed by telephone without a signed purchase order at hand and a written confirmation is to be sent by mail or fax unless delivered to supplier on pick up of goods. Indicate on the retained copy that the order has been sent so duplicates are not sent. For Portland File purchase order in alphabetical order of supplier in Portland Orders folder. Miscellaneous orders that are not products are filed in 'Pending Orders" folder. For Vimek Purchase order numbers are recorded in the respective manufacturing orders and/or operations control sheets. File original (if faxed) or photocopy in the incomplete purchase orders folder kept by the Production Manager or Office Administrator to await receipt (see next section 3). The information is retained in Exchequer. Documents or Records to be Produced Nil 2.5 Revising purchase orders Manager If a purchase order is to be revised, the revised requirements will be recorded on exchequer. If the cost is substantially affected, the revised purchase order will be submitted to the CEO for approval. Revised purchase order prints should be attached to the originals to maintain a full history of the purchase order. 'J Documents or Records to be Produced Amended Exchequer entry & Print out of Purchase Order Page 7 of 18

8 3. PROCEDURE RECEIVING & INWARDS INSPECTION Purchase Order cia I? I lf Implants I I I If 1 Other Fmished Goods I I I Subco :racted I Processes I If Batch Controlled Material I I....1 Stock.: _) Page 8 of 18

9 PROCEDURE- PURCHASING & RECEIVINGNERIFICATION 3.1 Receiving purchased goods & notifying PO originator Authorised employee Check items are for our company and the correct number of packages has been received. Then sign for the goods and ensure the goods remain in the designated receiving area with the delivery docket to await verification. Identify the originator or approver (if not on delivery docket, then by finding purchase order number from the delivery docket, pulling the purchase order from the incomplete purchase orders file) and advise the person that the goods have been received. If purchase order cannot be found, notify Manager Production. Delivery docket with goods in the receiving area 3.2 Verifying purchased goods PO Originator or Approver Obtain copy of purchase order and if it has Lot No.s on it, the relevant OCS's. If a purchase order cannot be found, check if items are customer supplied goods and if they are, follow ' Verifying Customer Supplied Goods Process' below. If verification by customer is required, arrangements are made with the customer to verify goods or materials at our premises or sub-contractor premises as required by specifications. Ensure customer supplies the company with written verification of inspection and attach copies to relevant OCS. If the order is in one of the categories listed, see relevant section below: a) Implants b) Other Finished Goods Stock c) Subcontracted Processes d) Balch Controlled Material e) Manufacturing Stock Checking Check the delivery docket details against the specified requirements in purchase order. Check certification requirements of purchase order. If certification is required but not yet available attach the documentation to the purchase order and hold the goods in the designated receiving area until certification has been received. If the goods do not have a Part Number, or no inspection requirements are defined on the Purchased Product Specification, a minimum inspection would be to verify items and quantity. Page 9 of 18

10 Vimek Stamp the purchase order with the "Inwards Inspection" stamp. Record the details of the delivery on the stamp and sign off. Forward to the Production Manager or relevant manager for approval to pay. Inwards Inspection Stamp: If it is a part delivery, photocopy the endorsed purchase order; attach the Delivery Docket and forward to accounts. If the delivery completes the purchase order, attach the delivery docket to the endorsed purchase order and forward to accounts for entry into Exchequer. Portland Enter into Exchequer; Exchequer will retain entry person's identification. Storage For non-stock items and items that are not part of list above i.e. Finished Goods or Manufacturing Order, the goods & any documents (except delivery docket I invoice and purchase order) are to be stored at the discretion of the purchase order Originator. Written customer verification of inspection attached to OCS Authorised inspection result recorded on purchase order 3.2 a) If Verification of Implants PO Originator or Approver Checking If it is an implant, Check type, lot number and serial numbers against delivery docket or certificate of conformance that came with the goods; Check if Certificate of conformance is accepted. Page 10 of 18

11 Documenting PORTLAND GROUP QUALITY SYSTEM Insert any lot number, serial numbers, use by date and deliveries against the purchase order in Exchequer; Print a Receipt Note for Serial Numbered implants showing serial /lot numbers; sign off by person who did the entry & by person checking. File in relevant Product History File. Storage Refer to PROC-012 Storage, Handling & Transport 3.2 b) If verification of other Finished Goods for stock PO Originator or Approver Checking If the purchased product has a Part Number, verify goods against the available "Purchased Product Specifications". If it has a stock code but not an implant Check type and lot number against delivery docket that came with the goods; Documenting Insert deliveries against the purchase order in Exchequer; Storage Refer to PROC-012 Storage, Handling & Transport Lot number I identification on finished goods cartons/packages. Lot number on delivery docket & test certificat e s Entries in Exchequer 3.2 c) If Verification of subcontracted goods processed to specifications Manager Production Authorised Employee Checking In general, Subcontracted goods processed to our specifications are to be 100% inspected for functional dimensions, or inspected by sample inspection in accordance with the purchase order or associated detail drawing(s). Documenting When determined from OCS or purchase order that an item is a subcontracted goods: Page 11 of 18

12 PROCEDURE- PURCHASING & RECEIVINGNERIFICATION 1. Enter the result of the inspection against the relevant process in the operations control sheet and sign the entry. If required on OCS, record certificate number. 2. File any certificates, notes etc with the OCS for filing. Storage Relocate goods passed to the next operation or to the work in process rack as per the operations control sheet. Authorised inspection result recorded on purchase order and operations control sheet [F021] Subcontractor QC details or certification where specified 3.2 d) If verification of batch controlled material PO Originator or Approver ) Checking Check if any test certificates supplied have met requirements. Check per relevant PPS. Documenting When determined from OCS, or purchase order or "Purchased Product Specification" that an item is batch-controlled material: 1. Enter the details against the next available number in the materials batch register. 2. Clearly label the material in an appropriate fashion (e.g., with a label, indelible marker, tie-on tag or engraving etc) with its batch number. 3. Write the batch number on to the delivery docket or any test certificates accompanying the material. 4. For materials that are to be made into implants or where required by OCS (i.e. customer) or "Purchased Product Specification", cut a sample piece of material and engrave with the batch number and heat I traceability number. This sample is retained in the marked bin(s) located in the batch-controlled area. 5. Photocopy any delivery docket and attach to test certificate(s) (if any) and file in the batch materials test certificates file. Alternatively, ensure that the purchase order number is recorded on the test certificate before filing. Storage Relocate the material to the batch controlled material and components rack. Batch register entry Batch number on all material pieces Batch number on delivery docket & test certificates Test certificates and delivery dockets batch material file Page 12 of 18

13 3.2 e) If verification of Manufacturing Stock PO Originator or Approver Checking Per 3.2 Checking Documenting If an item is for a Manufacturing Order (when determined from the delivery docket or purchase order): Clearly label the cartons/ packages with the lot number specified in the purchase order or on the OCS [P0602], otherwise label the goods with the P.O. number. Write the lot number on the delivery docket and any test certificates accompanying the goods. File any certificates, notes etc with the OCS. J For stock items, give the Logistics a copy of the Delivery Docket with a note written on it indicating that the goods are to be entered into the stock control system. Storage Arrange transfer into stock with Production Manager or Manufacturing Engineer. Lot number I identification on finished goods cartons/packages Lot number on delivery docket & test certificates 3.3 If Verification cannot be completed or fails PO Originator or Approver 1. If the delivery is rejected for not meeting specification, raise a non-conformance report [FORM-011 or F001] per PROC-003 or P Relocate the goods to the designated quarantine area clearly labelled with its purchase order number. 3. Pass the purchase order stapled to the delivery docket and NCR to the Administration Manager or Production Manager to co-ordinate its evaluation and disposition [PROC- 003 or P1301] or to await further information (e.g., certificates, etc). J Purchase order number on quarantined goods Non-conformance report [FORM-011 or F001] Page 13 of 18

14 PROCEDURE- PURCHASING & RECEIVINGNERIFICATION File original purchase invoice, any conformance certificates and delivery note into " Vimek Deliveries to Portland" file. For Vimek The signed off Purchase Order, Delivery dockets and invoices are filed in the Purchase Order File by financial year, supplier, and then by purchase order number. If a partia,l, r delivery (i.e. the order is still incomplete) is made, the original is again filed with inco m plete orders. Nil Page 15 of 18

15 PROCEDURE- PURCHASING & RECEIVINGNERIFICATION 4. PROCEDURE PETTY CASH PURCHASES 4.1 Purchasing by petty cash Manager Authorised Employee Petty cash can be used to buy goods up $100. The Production Manager, Operations Manager (or delegate) must authorise all petty cash purchases before the goods are bought. A receipt must be obtained for the purchase and given to the Production Manager for reimbursement. Documents or Records to be Produced Nil 4.2 Verification Manager Authorised Employee Petty cash should only be used for purchasing items or services that do not affect the quality of our finished product. Where the purchased product or service can affect the finished product, then it should be inspected. Because there is no purchase order for recording the inspection as per normal, then verification is to be recorded in some manner e.g. test certificate or certificate of conformance which would be stored as per normal procedure in Manufacturing Order records. Documents or Records to be Produced Possible Verification record e.g. test certificate or Certificate of Conformance Page 16 of 18

16 PROCEDURE- PURCHASING & RECEIVINGNERIFICATION 5 VERIFYING CUSTOMER SUPPLIED GOODS PROCESS 5.1 Receiving and verifying customer supplied goods for processing by Vimek Authorised Employee 1. Customer supplied goods are held in the goods inwards receiving area until the customer documentation is received for checking. 2. Check goods against customer documentation for item specifications & quantity and notify any damage or discrepancies to the Manager Production. Any deficiencies are notified to the customer in writing. 3. On completion of inspection, write "Inwards check" on documentation and sign and date as verification. Authorised inspection result recorded on customer documentation. ) ;/ 5.2 Storage Authorised Employee Tag/label or mark all materials, goods or their containers with manufacturing order number. Refer to Manager Production for storage location. Tag/label or mark on all material 5.3 Filing Authorised Employee Return Customer Purchase order to its Manufacturing Order with Manager Production. Nil Page 17 of 18

17 APPENDIX A RECORD OF CHANGES Issue No. RECORDED AMENDMENT DATE DCN# 1 Release. This is a combination of Vimek P0602, 15/4/ P1 001 and Portland PROC-005 relevant sections. 2 Sect. 2.1 Supplier information has been simplified and added checking box. Sect 2.3 added checking & signing PO. File titles updated (Sect 2.4, 3.10) Re-arrange order of information & re-numbered in Section 3 to make the process clearer. Delivery docket is optional (not always supplied) Added flowcharts sect 2 &3 Page 18 of 18