The proper application of a QA/QC program in high purity systems can make the difference between meeting cost, schedule and quality … or not!
In preparation for a recent project for a biopharma project in Florida, an experienced mechanical process piping installer wanted assistance with their QA/QC program before work started, and support in applying it during the project. They knew the quality standards they would need to meet and had a tight cost and schedule within which to work. Rework wasn’t an option.
First, AMA provided BPE and GMP-compliance training to thier QC personnel and tradespeople. We assisted in developing document control and tracking protocols; drafted final P&ID redlines, coordinated as-built details and field revisions to controlled isometric drawings ensuring the contractors meet project specifications and QA requirements. We also provided materials receiving inspections and issues tracking support to the construction manager and to the HVAC contractor as quality concerns arose around vendor packaging and shipping practices.
Our client achieved their financial goals while meeting schedule and quality objectives for the owner.