While blending a low does OTC headache compound, Bob, a sr. tech diligently filled in his batch report.  Before signing the report Bob discovered  that he accidentally recorded the weight as 51 pounds when he meant to record 15 pounds.

Bob drew a single line through the 51, changed it to 15, initialed and dated the change.  He also made the notation “numbers were inverted” Bob then brought you his batch report for review.

Questions:

1.  Is Bob’s method of capturing the change acceptable?

2. Would this require escalation and if yes, what would be your escalation level (NCR, CAPA etc.) 3. Does your SOP outline how to handle human clerical errors on regulatory forms and if so, what does it direct you to do?

Your firm has been making a part for five years.  The gauge you have used to measure the inside diameter has been classified as obsolete.  You have pulled the gauge off the floor.

Here is the question:  Would you calibrate the obsolete gauge, even though you will never use the gauge again?