Equipment Qualification Services
Path Forward Consulting LLC takes a tremendous amount of pride in offering CQV (commissioning, qualification, and validation) services for both manufacturing processes and equipment. This is typically a service that is rendered for manufacturers of FDA regulated products (food and beverage items, medical devices, as well as pharmaceuticals). However, it is also rendered for manufacturers of non-regulated products who are ISO certified, or for those who want to ensure their equipment performs as intended.
The qualification process is a regimented procedure that is focused on delivering on a commitment to consumer trust and safety, by ensuring that newly installed equipment or processes:
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Were installed / integrated in a manner consistent with O.E. manufacturer or design specifications.
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Physically operate and perform in a manner consistent with O.E. manufacturer or design specifications.
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Deliver a product and / or other output that is consistent with desired manufacturer specifications.
This is typically a three phase process that begins with an installation qualification (IQ), which is then followed by an operational qualification (OQ), and a performance qualification (PQ).
Equipment Qualifications
Standard Offerings & What is Included
Pre-Kickoff CQV Consultation
We'll work with internal stakeholders as well as external entities to assist you in developing a glidepath / scope for project-related CQV efforts. This is a comprehensive examination of the who, what, when, where, and why with respect to successful qualification efforts.
CQV Project Management
We'll manage the CQV element of the project so your engineering / project team doesn't have to. We will fully integrate ourselves into the project management lifecycle and work with internal staff, external entities, contractors, and vendors, to manage qualification efforts and timetables.
Creation of a URS / FRS
The URS (User Requirement Specification) or FRS (Functional Requirement Specification), is the lifeblood of qualification efforts. In some instances, this may also be referred to as the OPR (Owners Project Requirements). This document outlines a comprehensive list of traits, performance characteristics, design elements, and finished product specifications (among many other things), that must be met in order for the project to be successful.
Development of Protocols
Our team will take charge of developing qualification protocols that verify your equipment has met each criterion within the URS / FRS / OPM. These protocols are reviewed and approved by internal stakeholders within the client's organization to make sure they meet all business and regulatory needs. Once they have been approved, they become an auditable and discoverable record of qualification activities.
Factory Acceptance Tests
A representative from our team will attend factory acceptance tests (FAT's) as required. A separate FAT evaluation document will be generated and annotated as the FAT is executed. Additionally, we'll use the FAT as a way to verify whether or not certain aspects of the URS / FRS / OPM have been met.
Execution of Protocols
The team will be present as equipment is installed at the client's facility and will execute installation qualification (IQ) protocols in-stride with construction efforts. As equipment is installed, we'll ensure that we witness any vendor provided SAT (Site Acceptance Test) activities and perform operational qualification (OQ) in parallel. Upon successful completion of the (OQ), we will assist the client in executing and documenting performance qualifications (PQ). As all these efforts are completed, the qualification documents are reviewed, approved, and kept as auditable and discoverable evidence of due-diligence.