ALCOA Principles
This "A" in ALCOA means that every entry must be traceable to the person who recorded it.
What is Attributable?
Always use this type of ink when recording information.
What is blue or black indelible ink?
You copied a number from one document to another, but you wrote it down wrong. What error code would be used?
You accidentally spill ink on your record. What should you do?
Cross it out, write an explanation, re-write if necessary, and initial and date.
GDP important to ensure that this type of product is consistently made and controlled.
What is a safe and effective product?
This "C" in ALCOA means that entries must be made at the time the activity is performed
What is Contemporaneous?
This is the correct way to fix an error in documentation.
What is to:
1. Draw a single line through it
2. Write the correction
3. Explain the reason for the correction
4. Initial/Date?
You added up material weights, but your math is incorrect. What error code do you record?
What is CE - Calculation Error?
You notice a someone signed off something they did not perform. What should you do?
Report to your supervisor immediately.
Regulators like the FDA or EMA review documentation to confirm this.
What is compliance with cGMP and product quality?
This "O" in ALCOA means that an entry should be made in the approved documentation, not written on a scrap paper to be copied later.
What is Original?
True or False: It is acceptable to use scrap paper to document data when completing documentation.
Your writing in a logbook can't be read clearly, so you rewrite it correctly. What error code applies?
What is IE - Illegible Entry?
During tanker unloading, you forget to record a check until 20 minutes later. How do you document it?
Poor documentation could lead to this consequence.
What are recalls, regulatory actions, or warning letters?
This "A" in ALCOA means information must be correct, truthful, and without errors.
What is Accurate?
True or False: It is acceptable to pre-sign a form if you know you will complete the task later.
What is False?
You forgot to fill in your name in a signature log. What error code would be used when you go back to fix it?
Your record prompts for an N/A, but you leave it blank. Is this acceptable?
No, you must mark N/A, initial, and date to show it was intentionally not applicable.
True or False: If it is not documented, it did happen.
Together, ALCOA+ includes additional principles like Complete, Consistent, Enduring, and this one, meaning data can be read and understood in the future.
What is Available?
If you're filling out a form and realize you don't have the correct information yet, what is the right action?
What is wait until the activity is complete, then record the data contemporaneously - never leave it blank or guess?
You forgot to record a critical temperature check. What error codes applies and what do you need to include with a correction?
What is ME - Missed Entry and the information should come from another data source, like PI?
You see a mistake in a logbook from last week. Who is allowed to correct it?
The original person who made the entry, or with proper documented justification if they are unavailable.
Operators are the first line of defense for product quality becuase they are responsible for this.
What is accurate, timely, and compliant documentation?