ALCOA+
What does the 'A' in ALCOA stand for?
A= Attributable
L
C
O
A= Accurate
Is this true or false?
Blank spaces/fields on GMP documents are acceptable if they donāt apply
False
Lily is a supervisor. At the end of her shift, she was reviewing Batch Production Records (BPRs) and became extremely concerned about an observation written by her team member, Zac.
She felt that the observation was not clearly written. Therefore, she decided to clarify it by writing a second, new observation herself.
Lily then instructed Zac to date and initial this second observation as if he had written it.
When the Quality team received the BR from Lilyās group, they immediately noticed that the two observations were written in different handwriting, yet both had Zac's initials.
Which ALCOA+ principles have not been respected? Provide minimum 1.
Attributable
The second observation was written by Lily but falsely signed by Zacāmisrepresenting who did the work.
What else?
______________________________
Original
The rewritten observation replaced or altered the original without proper documentation.
Accurate
The new entry may not reflect Zacās actual observation, introducing potential errors.
Contemporaneous
If the second observation was written later and backdated, it wasnāt recorded in real time.
Legible
Unclear initial observation by Zac triggered Lily 's attempt to address the issue.
Different handwriting exposed the issue
What does the 'C' in ALCOA stand for, and can you pronounce it š?
A
L
C=Contemporaneous
O
A
Is that true or false?
Post-it (sticky notes) are acceptable to document GMP raw data.
False
Suzanne, a senior process technician, is an excellent worker known for her commitment to team goals and meeting production schedules on time.
One day, she accidentally forgets to mark a step as "N/A" in the Batch Production Record (BR).
A few days later, Manufacturing Quality identifies the omission and informs Suzanne to correct it.
Due to her busy schedule, Suzanne delegates the task to Robin, a new employee. Robin crosses out the empty box, marks it as "N/A," and adds Suzanneās initials along with the actual date the task was performed.
Meanwhile, Andreas, Suzanneās supervisor, is behind schedule due to a contamination issue. Trusting Suzanneās usual accuracy, he signs off as the final Manufacturing Reviewer without verifying the correction.
Which ALCOA principles have not been respected? Provide minimum 2.
Attributable
Robin made the correction but used Suzanneās initials, falsely attributing the action to her. This misrepresents who actually performed the correction.
Contemporaneous
The correction was made days after the original omission, and the date entered may not reflect the actual time of the correction.
What else?
______________________________
Original
The correction was not made by the original person responsible (Suzanne), and the change was not properly documented as a correction or clarification.
Accurate
The correction does not truthfully reflect who performed the action or when. This compromises the accuracy of the record.
What do 'L' and 'O' in ALCOA stand for?
A
L=Legible
C
O=Original
A
Which from the following statements is not true?
1. Repetition signs such as quotes, arrows or "dittoā are not acceptable
2. Lonza uses 12h clock format
3. Lonza uses DD.MMM.YYYY date format
Lonza does not use 12h clock format. Lonza uses 24h clock format.
A quality audit was being conducted at a manufacturing facility.
During a tour of the area, the auditor noticed a crumpled piece of paper in a trash bin. This prompted the immediate initiation of a deviation to investigate the situation.
The investigation revealed that, prior to the inspection, a review of a logbook had identified numerous corrections, making the record appear messy.
In an effort to present his team as diligent and organized, Chan, the team lead, printed a new log and transcribed all data from the original into the new version. To ensure accuracy, he asked his peer, Ben, to verify the transcription. Ben confirmed that no errors were made.
Chan then discarded the original record and replaced it with the new, cleaner version.
Which ALCOA principles have not been respected? Provide minimum 2 and explain why the auditor did not like this situation?
Original
The original logbook was discarded and replaced with a transcribed version. This violates the requirement to retain original records.
Enduring
The original record was not preserved, which compromises the enduring nature of data, records must be maintained in a durable and retrievable form.
What else?
Attributable
By transcribing the data, the original authorship and timestamps of the entries may no longer be clearly linked to the individuals who performed the work.
Accurate
Even though Ben verified the transcription, copying data introduces a risk of transcription errors or omissions. The new record may not fully reflect the original context or corrections.
Contemporaneous
The new log was created after the fact, not at the time the original entries were made. This undermines the real-time nature of data recording.
What does ALCOA stand for?
A=Attributable
L=Legible
C=Contemporaneous
O=Original
A=Accurate
Which from the following statements are true?
1. I can mark 'done' in the checkbox for an activity I forgot to complete
2. I can modify a parameter that is 'nearly' in specifications, to make it fall 'within specifications'
3. I can modify data without justification if I āthinkā the impact is low
4. I promise to remember and apply ALCOA+ principles and and do the right thing, even when nobody is watching
I promise to remember and apply ALCOA+ principles and and do the right thing, even when nobody is watching
Asus performed a post-use filter integrity test at a workstation next to his colleague, HP.
After multiple failed attempts, Asus became extremely frustrated. Eventually, he decided to use a new filter to conduct the test, which passed. He then recorded only the passing result in the Batch Production Record (BPR) and discarded the data from the failed attempts without documenting them.
Which ALCOA principles have not been respected? Provide minimum 2 and explain what you think HP should do?
Original
The original test results (the failed ones) were discarded. This violates the requirement to retain original data.
Complete
The record is incomplete because it omits the failed test attempts, which are critical to understanding the full testing history.
What else?
__________________
Accurate
The BPR only reflects the passing result, which gives a misleading picture of the testing process. This compromises the accuracy of the record.
Contemporaneous
If Asus discarded the failed results and only recorded the final passing result later, the data was not recorded at the time the work was performed.
Attributable
The record does not reflect all actions taken by Asus. By omitting the failed attempts, the data is not fully attributable to the actual sequence of events
What does '+' in ALCOA+ stand for?
The "+" in ALCOA+ refers to 4x additional principles that build on the original ALCOA framework to further strengthen data integrity, especially in regulated environments like pharmaceuticals and biotech:
What do you think are four Lonza Data Integrity "Golden Rules"?
1. Record data truthfully and accurately at the time of performance
2. If the data doesnāt look right, just guess what it should be
3. Report any issues regarding data
4. If you need to backdate something, just make sure your handwriting looks consistent
5. Always check data carefully to ensure they are correct
6. Never alter data without a clearly documented justification
1. Record data truthfully and accurately at the time of performance
2. If the data doesnāt look right, just guess what it should be š±
3. Report any issues regarding data šš
4. If you need to backdate something, just make sure your handwriting looks consistent š±
5. Always check data carefully to ensure they are correct šš
6. Never alter data without a clearly documented justification šš
During FDA inspection, the inspector found torn documents in trash bags that contained stability study data, analytical testing sheets, analysis calculations, and release forms. The inspector was able to remove some documents from the trash and found that the data showed out-of-specification results: however, the official results were recorded as within specification. The inspector also found blank stability study forms that were prepared, signed and approved by the quality unit before test data were recorded. FDA asked the company to provide a corrective actions and preventative actions plan to the agency
Which ALCOA principles have not been respected? Provide minimum 3.
Accurate
The recovered data showed out-of-specification (OOS) results, but the official records falsely reported them as within specification. This is a direct falsification of data
Original
The original documents were discarded (torn and thrown away), and only some were recovered. This undermines the requirement to retain original records.
Contemporaneous
Signing and approving forms before data was generated means the records were not created at the time the work was done.
What else?
Attributable
Blank stability study forms were prepared, signed, and approved before any test data were recorded. This falsely attributes actions to individuals before the work was actually performed.
Legible
Torn documents found in trash bags may have been damaged or partially destroyed, making them difficult or impossible to readācompromising legibility.