GxP
The M in GMP stands for this.
What is manufacturing?
This KPI measures the percentage of batches that pass inspection on the very first attempt, with no rework or retesting.
What is First Pass Yield (First pass prime)?
CAR stands for this.
Corrective Action Request
This department is responsible for ensuring the finished product meets the customers and company standards.
What is the Quality Department?
This type of audit happens when inside your own company, on a schedule that can be annual or risk based.
What is internal audit?
This specific GxP topic focuses on creating and maintaining accurate, complete, and traceable records?
What is Good Documentation Practice?
This approach uses historical data to predict a drift (like a pH shift before it ever hits the spec limit)
What is trend analysis (or predictive analytics)?
This is a process to identify the underlying reasons behind an issue, enabling you to fix it permanently rather than just addressing the symptoms.
What is root cause analysis?
In supply chain, this document from the supplier is the first thing checked to decide whether a raw material is acceptable for use.
What is a Certificate of Analysis (CoA)?
These three initials (REACH, TSCA, and GMP) are examples of the regulations the regulatory affairs team monitors for changes.
What are chemical industry regulations?
The c in cGxP stands for this.
What is current?
This system, often abbreviated LIMS or MES is what plants use to automatically collect batch data instead of relying on operator entry.
What is Laboratory Information System Management System?
This common RCA mistake happens when you fix the immediate issue but never ask why it happened in the first place?
What is treating the symptom (or putting out the fire)?
In production, this is the formal sign off that proves the previous product is fully cleared from the equipment before a new campaign begins.
What is line clearance?
This continuous improvement methodology uses belts (white, yellow, green, black) to train people in data driven problem solving.
What is Six Sigma
This acronym is foundational to GxP data integrity and requires that records be attributable, legible, contemporaneous, original, and accurate.
What is ALCOA+?
This root cause analysis technique involves asking a simple question repeatedly until you move past symptoms and uncover the true origin of a problem.
What are the 5 whys?
This tool uses a diagram to brainstorm potential causes across categories like people, process, equipment, materials, environment and measurement
What is cause and effect (or Ishikawa/fishbone) diagram?
In P&AD this hand off document must be validated and formally transferred before the QC lab can begin testing a new product at scale.
What is a test method (or analytical method)?
The Japanese management practice involves leaders going to the actual workplace to observe processes firsthand, identify waste, and engage with the people doing the work.
What is Gemba?
This formal process must be completed before you make any changes (supplier change, upgrade a piece of equipment, revise a SOP) no matter how minor.
What is change control (or change management)?
The two types of process variation: one is inherent to the process, the other signals something has changed.
What are common cause variation and special cause variation?
This formal root cause analysis methodology, developed by system improvements, uses a root cause tree and emphasizes SMART corrective actions.
What is TapRoot?
By tying quality to this leadership rewards doing quality work and shows quality is about more than just production numbers.
What are performance reviews (compensation/bonuses)?
Japanese word for improvement, defined as a continuous effort by each and every employee to ensure improvement of all processes and systems of a particular organization.
What is Kaizen?