VAL-030 Equipment Specification and Qualification

1. General

1.1. Responsibility – Project Manager

It is the responsibility of the Project Manager to ensure that members of the Project Team are aware of and proceed with procurement in accordance with this SOP.

1.2. Good Engineering Practice

The goal of this procedure is to ensure that process equipment and systems are developed and supplied in accordance with Good Engineering Practice (GEP).  GEP recommends that:

a. Equipment should be built in accordance with plans and specifications, approved or authorised by the appropriate individuals

b. Equipment should be inspected, tested and documented by qualified individuals

c. A minimum level of documentation should be provided for all systems and equipment

d. Documentation should cover design, fabrication, construction, inspection and commissioning phases.

By working with suppliers, an appropriate level of documentation for equipment can be developed with a minimum of redundancy and with the maximum potential for their use as part of the qualification support package for the equipment.  Some items of equipment may require additional tests or documentation, however the goal of this SOP is to ensure that the engineering documents may support these requirements without the need to repeat any work or compromise validation standards.

To support this goal, the Project Manager will need to ensure that:

a. All of the documents that are required at the end of the project are prepared, approved and collected throughout the project.

b. Document versions and approvals are managed in line with project milestones.

c. The relevant departments for review and approval of documentation are identified and included in the project.

2. Procurement Documents

2.1. The documents used for the procurement of equipment should consist:

a. User Requirement Specification

b. Relevant Standard Demand Specifications, and

c. Purchase Agreement.

These documents should form part of the Purchase Order.

2.1.1. The User Requirement Specification covers the specific requirements of the equipment to be procured. It is to be prepared by the procurer.

2.1.2. The Standard Demand Specifications cover the general standards for equipment for manufacturing premises.  They are the reference points regarding the principles, requirements and precautions that should be followed to safeguard product quality, EHS objectives, GMP and GEP on site.  They are also intended for application to achieve efficient standardisation of equipment, components, hardware and software in the facility.

2.1.3. These Standard Demand Specifications should be reviewed before undertaking any procurement.  If they contain any clauses that are pertinent to the equipment procured, they should be included in the demands of the procured item.

2.1.4. For the case of non-conformance with any clause in the Standard Demand Specifications, agreement to the alternatives shall be reached with the Demand Specification Owner before proceeding with the Purchase Order.

2.1.5. The requirements specified in the Demand Specifications should form part of the inspection checklist for the equipment for Factory Acceptance Testing and Site Acceptance Testing.  The completed checklists should be attached to the Installation Qualification documentation.

2.2. User Requirement Specification

2.2.1. The URS specifies the scope of work and the process requirements for the equipment or system, (i.e. what the equipment or system is supposed to do).

2.2.2. The URS should be checked to ensure it is clear, complete, realistic, definitive and testable.  The URS should also be approved by the Engineering Service and, if it has Direct or Indirect GMP impact, a representative from the Quality Assurance department.

2.2.3. Once approved, this document forms part of the Validation documents and is to be archived as per GMP document.

2.2.4. The URS should:

a. Clearly define any design constraints

b. Nominate the Standard Demand Specifications that form part of the procurement.

c. Support operation and maintenance of the system

d. Be a simple, complete and coherent description; avoiding omissions, ambiguities, duplications and contradictions

e. Define the system in a way that will be testable

f. Include the requirements for Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).

g. Identify the significant functions for product quality and GMP compliance

h. Permit tracing of specific requirements through subsequent documents

i. Avoid unnecessary technical detail and be understandable by both user and supplier

j. As far as possible, not identify a specific solution to be used, but rather the business requirements.

2.3. Mechanical Design Specification:

This standard document covers the mechanical design elements and selection of materials required.  It also covers guarding, frame construction, pneumatics and conveyors.

2.4. Electrical Demand Specification:

This standard document covers demands for electrical cabinets including set out and design of wiring circuits.  The document also covers all aspects of electrical control including PLCs and aspects of electrical installation and preferred makes.

2.5. Instrumentation Demand Specification:

This standard document covers demands for instrumentation and calibration requirements.  The document also covers recording of instrument information including manufacturer’s information and spares.

2.6. SCADA Demand Specification:

This standard document covers demands and configuration set up requirements of Supervisory Control and Data Acquisition system.  The document also includes site networking standards.

2.7. Control System Demand Specification

This standard document is used to describe the standard approach to control system operations.  It includes definitions of emergency stop strategies, interlock and guarding philosophies.  It also identifies programming standards that will be verified during Structural Testing.

2.8. Technical Documentation Specification:

This standard document covers the outputs required from a supplier’s Quality Management System, (QMS) including specifications, test records, change control, and operation and maintenance manuals.  A QMS is an important part of assuring GEP and is necessary for critical projects (including aseptic pipe-work and customised computerised system developments).  It also describes the standards for drawings that are submitted during the procurement, including title blocks, drawing references and formats.

2.9. EHS Audit Report:

This is used for the site risk assessment of the installed equipment prior to SAT.  It does not contain hidden text. This document does not form a part of the initial procurement document-set but is used later in the project.

2.10. EHS Requirements Specification:

This standard document covers Environmental, Health and Safety (EHS) requirements for the purchase, fabrication, installation, operation and modification of plant and equipment.  It converts to a EHS Verification Report using hidden text.

2.11. Purchase Agreement

2.11.1. The commercial conditions that should be specified depend on the nature of the procurement.  The factors to take into account include size of purchase cost, contract arrangement, e.g. fixed price contract, time and materials or design and construct contract, intellectual rights ownership, etc.  The Supply Chain Procurement Manager should be included in the assessment of the conditions that are appropriate.

2.11.2. One of the ways that the commercial conditions can be covered is by the inclusion of a Purchase Agreement as part of the Order.

2.11.3. The Purchase Agreement covers terms of payment, timetable, performance warranties, intellectual property rights, confidentiality agreement, termination conditions. The Purchase Agreement should form part of the Tender documents so that the supplier can review it before they submit their tender.

3. Managing Supplier’s Documentation

3.1. The normal expectation of this procedure is that suppliers will respond to buyer’s requirements document with their own specifications and proposals (including those for testing).  These should address the requirements outlined in the documents and identify in more detail how they will satisfy these requirements in the equipment the supplier will develop, and by the processes the supplier will operate to manage this development.  The Project Manager is to ensure that each of the supplier’s proposals are reviewed and approved by relevant personnel, prior to the supplier undertaking the proposed works.  Relevant stakeholders for this review may include:

a. Project Engineers, for mapping the sufficiency of the supplier’s proposal against the in-house requirements.

b. Electrical Engineers, for assessing Control Hardware and Software proposals.

c. Quality Assurance Officers, for identifying areas of GMP impact and assessing Quality Management System procedures.

d. Validation personnel, for evaluating Test Methods and Results.

3.2. Each reviewer should be clear as to his or her role within the review process and comfortable they have the necessary understanding to perform this task.  Reviewers should mark-up documents with observations and record their name, date and signature on completion of the review.

3.3. Supplier documents are likely to require revision through the project.  The Project Manager should ensure that each version is released in a controlled manner; identified with a unique version number and document status, (e.g. “for construction”, etc.).

3.4. The supplier should have a procedure that identifies when version updates will be required and how they will be initiated.  This would ideally include the production of “as-built” versions at completion of the project.  A copy of each approved version is to be retained by the Project Manager, to demonstrate control of the development ‘life-cycle’.  Electronic copies of final versions should be filed.

3.5. Test documents, generated by the supplier or buyer’s project teams, may be used to complement Validation documents and may limit the need for additional Validation testing.  Such an approach requires the prior agreement of the Validation Manager and will mean that these test documents must meet the standards for Validation evidence.

4. Design Qualification Documentation

4.1. Design Qualification (DQ) is a process for assuring that the designs of equipment and systems comply with the requirements for use and, most specifically, the code of GMP.  The process should commence prior to the construction or manufacture of the item in order to minimise the impact of any omissions, errors or changes.  A number of activities may be conducted as part of the Design Qualification, including, but not limited to:

a. Verification that design meets relevant URS or standards

b. Verification that cGMP requirements are identified and met

c. Examination of the material and personnel flow diagram

d. Supplier Assessment / Audit

e. Design Review (eg against a checklist, or by a team)

f. Risk Assessments (eg Product Quality).

4.2. The Project Manager will initially determine the most appropriate review method, based on the system impact, complexity and novelty.  The proposed Design Qualification approach should be documented and approved.  A Design Qualification Report should record the completion of all the planned activities and the location of any supporting evidence.

5. Installation Qualification Documentation

5.1. To complete Installation Qualification, the Project Manager should ensure that all the relevant Installation Qualification documents have been completed.

The documents should include:

a. All Mechanical Demand Specifications.

b. Electrical Demand Specification.

c. Instrumentation Demand Specification.

d. SCADA Demand Specification.

e. Control System Demand Specification.

f. Technical Documentation Specification.

g. EHS requirements in the EHS Verification Report.

h. EHS Audit Report.

i. Standard Installation Qualification documents relevant to the project should also be completed.

j. FAT report, covering the criteria and test results defined in the URS.

k. SAT report, covering the criteria and test results defined in the URS.

6. Project Manager’s Responsibilities:

The Project Manager’s responsibilities includes:

– Ensure relevant Standard Demand Specifications form part of the procurement requirements.

– Check that all requirements of the Demand Specifications are met for the successful tenderer. Where requirements are not met, obtain agreement from the Demand Specification Owner on deviations.  After resolution, a new customised Demand Specification, with all the revised requirements, should be created as agreed with the Demand Specification Owner.

– Determine the design qualification activities appropriate to the project.  Ensure the approach is approved and implemented, and that completed tasks are recorded.

– Subject documents to review and approval by appropriate departments.

– Identify and record all specification revisions during course of procurement to meet change control requirements

– Maintain copies of approved versions corresponding to project.

– Do not use a previously customised Demand Specification (from another Procurement order) as a default document.  Always return to the original Standard Demand Specifications as the starting point for each new procurement.

– Log the project with the Validation Department and obtain a Validation Project Number. (SOP VAL-005).

– Follow requirements of Validation SOP VAL-005 (Validation Plan, Installation Qualification, Operational Qualification, Performance Qualification).

– During installation phase, use Demand Specifications as Installation Qualification documentation.

– Ensure that Contractors complied with SOP MAN-130.

– Verify compliance to all requirements that form part of the Purchase Order.

– Verify that EHS Requirements have been met.  An EHS Audit Report should be conducted on the installed equipment before SAT.

– Complete and compile all the Installation Qualification documents.

– Attach Factory Acceptance Testing report.

– Attach Site Acceptance Testing report.

– Update Drawings and register.

– Complete all other validation documentation requirements in accordance with SOP VAL-005.

– Arrange for all completed validation files, when approved, to reside in the Validation filing area.

7. Summary of Changes