Project Management & Validation

Tekpak operates an ISO9001:2008 accredited quality management system. Machines are manufactured and projects are managed in accordance with current good manufacturing practice (GAMP 5) and are designed to operate in 24/7 environments. Tekpak provide complete project management and documentation package required for machines which are being installed in Validation environments. These include:

documentation

Issue of a Functional Specification (FS)

A detailed document which clearly states how the objectives outlined in the clients user requirement specifications (URS) will be met along with the criteria for testing.

Traceability Matrix

A detailed matrix to enable cross checking User Requirement Specifications against Design Specifications issued

Failure Mode & Effects Analysis (FMEA) & Design Qualification (DQ)

A detailed and systematic review of all of the functions, their potential failure modes and a risk assessment of the possible effects.

Factory Acceptance Test (FAT) Protocols

Documents will be issued to the client and we will agree the format for the FAT.

Installation Qualification (IQ) Support

An IQ test plan will be issued which will list the tests to be carried out at installation. Typically, these will include:

  • Documentation check including training plans, operating manual etc
  • Assembly check to make sure that all the sub-assemblies have been securely fastened and that the appropriate connections have been made
  • Documentation of test data if applicable

An IQ report will be completed and any issues noted along with the corrective action plan. If corrective action has been taken, the test will be repeated. After successful completion of IQ, the Operational Qualification (OQ) can begin.

Operational Qualification (OQ)

The test process which assesses the correct functioning of the machine systems.  This will be carried out in accordance with a detailed OQ test plan. Typically, the tests will include:

  • Check the functionality of all sensors
  • Check all guard and safety switches/devices to make sure that they operate correctly
  • HMI navigation and functionality
  • Check all alarms and signals
  • Inspection of any emissions e.g noise
  • Inspection of pneumatic valves and vacuum devices

An OQ report will be completed and any issues noted along with the corrective action plan. If corrective action has been taken, the test will be repeated. After successful completion of OQ, the Operational Qualification (PQ) can begin.

Performance Qualification (PQ)

The purpose of the performance qualification is to test that the machine will carry out its required functions repeatedly after variables have been introduced e.g processes, operators, other environmental factors. Typically, this will be a 30-60 day period and the system will be measured against performance tests which vary depending on client protocols but may include:

  • Suitability of operator instructions in actual working conditions
  • Outcomes of machine related quality checks
  • Performance of the machine over time
  • Validation of the machine system in repetitive tests e.g when ‘x’ occurs, the outcome is ‘y’

Summary

From a machinery manufacturers and end users’ perspective, the process of project management for validated environments requires time investment but it pays off in terms of lower risks.  Machine functions and design is mapped out at an early stage and risks are assessed in great detail in the early stages. Also, there is greater transparency throughout the project team – everyone knows exactly what has been agreed and what the deliverables are leaving no room for surprises!

It seems like common sense and much of it is but it also requires someone who is experienced to steer a project through this process to avoid ‘over designing’ a system which can actually be counter-productive.