Problem: You are an assessor on a team who is assessing XYZ laboratory. You are familiar with the lab's Quality Assurance Manual (QAM) referencing Case Records. During the assessment, you noticed that during a case record examination, the examiner has used a pen to scratch out some data on a results sheet. New data has been written underneath of the scratch out. The examiner has initialed and dated the scratch out.
Is this a noncompliance of the lab's QAM criterion? If so, how would you word your finding? (Remember, write the nonconformance in the words of the standard) Include References.