Suppliers documentation

A purchase order (PO) from the EPCM contractor is the basis on which a supplier will provide materiel. The PO will require the supplier to generate a certain number of documents. These can include  

General arrangement drawings including weights, and lifting details 

Drawings of electrical and piping connections, that is, flange 

Records of inspection and tests carried out before shipment Certificates issued by an authority in the coimtry of manufacture 

Packing and shipping instructions Erection instructions Lubrication charts 

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Category 3—Standard Software Packages These are commercial, off-the-shelf software packages. The package is not conhgured, and process parameters may be input into the application. The name and version should be documented and verihed during IQ. Compliance to URS should be tested during QQ. Supplier documentation should be assessed and used. 

Most of these setpoints are fixed by the supplier, detailed in the purchase order, or are part of the installation qualification file. If the setpoints are fixed by the supplier, there are no acceptance criteria unless the supplier documents the setpoint in written form. When available from supplier s documents or when specified in the bill of order or the installation qualification report, the observed setpoints shall be compared with the documented ones. Any detected discrepancy is mentioned for investigation, justification, approval, or correction. When reported parameters are neither specified nor approved, they shall be mentioned as not specified. 

Capture the initial supplier documentation describing how they intend to meet the user requirements... 

OQ testing should only be conducted after the IQ has been successfully concluded. The scope of the OQ should be dehned in the Validation Plan. System Testing can be repeated or referenced to reduce the amount of OQ testing required, provided supplier documentation standards fulfill user qualification requirements. The OQ should cover ... 

The validation documentation set provided by a supplier of COTS will be standard rather than being tailored in advance with the users. Nevertheless, pharmaceutical and healthcare companies should map supplier documentation to validation requirements in an attempt to satisfy the latter. This mapping may be quite complex, and a direct correlation impossible. However, at a minimum the mapping should cover ... 

All documentation furnished by the supplier should be available. User manuals, as-built drawings, instrument calibration records, and procedures for operation and maintenance (including calibration schedules) of the system should all be checked to verify that they are suitable. Supplier documentation should be reviewed for accuracy in its specifications of the various versions of software used and approved as fit for purpose. It is recommended that checks are made to verify that contingency plans, SOPs, and any Service Level Agreements (SLAs) are also in place. Any specific competencies supposed to be acquired before the IQ/OQ/PQ through training should also have been achieved — these records should be checked. 

Pharmaceutical Manufacturer should have custody of this documentation plus summary reports of more detailed supplier documentation... 

An audit report will be produced for each supplier, documenting the positive and negative observations made during the assessment of the response to the postal audit questionnaire and/or the site audit. All corrective actions must be followed up, possibly requiring further site visits, in order to ensure that nonconformance issues have been appropriately addressed in a timely manner to minimize the impact on project success. 

Document (supplier documentation, SOPs, etc.) management and maintenance. 

The engineering firm will be responsible for identifying key supplier documents required for validation (IQ and OQ) and also specifications and ranges for equipment. The validation services will develop protocols for executing each component (IQ and OQ). Performance qualifications are performed after completion of OQ. The engineer or contractor will typically not be involved in PQ. Our experience has been that the producer will perform PQ on the new process. 

For each element of the infrastructure, technical specifications should detail what is to be installed, the purpose of the element being installed, the key operating parameters, the interfaces to other infrastructure and the key constraints of the system. These documents, which may include drawings, diagrams and some supplier documentation, must be reviewed, approved, formally controlled and kept up to date. 

Anodes should be selected in standard size according to information from an accepted anode supplier. As soon as the actual anode type, material, and size are selected, the anode parameters below can be defined from the supplier documentation and/or calculations [12] ... 

Progress of suppliers documents in terms of safety engineering requirements... 

Other supplier documents will be verified at source by the EPCM contractor s inspectors. The PO will also define the number of copies and the presentation, that is, hardcopy and/ or electronic format. The documents from each PO will be assembled into a single volume or a set of volumes called manufacturing data book (MDB) or something similar. It is advantageous that the format and presentation of these documents be standardized across all of the POs in order to facilitate their use. The MDB should be reviewed by the inspector before dispatch. 

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