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Work Instruction Plug-and-play starting point Data Integrity

Work Instruction: Investigator Interview Protocol for a Suspected Falsification Case

A plug-and-play, step-by-step work instruction for the fact-finding interview in a suspected data falsification investigation: preparation, the open account, introducing documentary evidence, closing, and documentation, with per-step acceptance criteria and a filled specimen.

Document type: Work Instruction

Read and copy the template below into your own quality system. It is a generic starting point for your own internal use, provided as is, with no warranty; see the Terms and License. Adopting it does not by itself create compliance.

This is a ready-to-use work instruction for the interview step inside a data integrity investigation where falsification is suspected, referenced from your parent investigation SOP. It is an investigative fact-finding tool, not legal or HR advice and not a disciplinary procedure. It does not decide guilt, outcome, or discipline. Legal counsel and Human Resources determine how an interview is conducted and used for any employment consequence; use this work instruction only to structure the fact-finding conversation itself, and route any accountability or disciplinary decision through your own HR and legal process. Replace every <<FILL: ...>> placeholder with your own specifics. A filled specimen follows the template.

Control header

FieldEntry
Work instruction number<<FILL: WI-ID, e.g. WI-QA-071>>
Parent SOP<<FILL: data integrity investigation SOP-ID>>
Version<<FILL: version>>
Effective date<<FILL>>
Owner<<FILL: role, e.g. Head of Quality Assurance>>

1. When to use this work instruction

Use this only after containment and preservation are complete (the questioned individual no longer has edit or delete access to the relevant systems) and after the documentary case, the audit trail review, the reconciliation, and the scope determination, is assembled. Interviewing before the documentary case is built turns the interview into the source of the facts instead of a check on them, which is the opposite of its purpose.

2. Roles for this step

RoleResponsibility
Lead interviewerAsks the questions, controls pacing, decides when to introduce evidence
Second interviewer / note-takerTakes contemporaneous, factual notes; does not lead questioning
LegalAdvises on conduct of the interview and any privilege considerations before it happens; may attend per company policy
Human ResourcesAdvises on employment process and attends where company policy requires it
IntervieweeMay be accompanied per your company’s own policy and any applicable employee representation rights

3. Step-by-step procedure

Step 1: Prepare

  1. Assemble the specific records, timestamps, and reconciliation gaps relevant to this person, already mapped from the documentary review. Do not bring an open-ended fishing list.
  2. Confirm with Legal and HR that the interview can proceed, who will attend, and how notes will be handled.
  3. Schedule a private setting with two interviewers and no interruptions.

Acceptance: the lead interviewer can state, before the interview starts, exactly which records will be shown and in what order, and Legal/HR have confirmed the format.

Step 2: Open the interview

  1. State plainly that this is a fact-finding interview as part of a quality investigation, not a disciplinary hearing, and that no outcome or disciplinary decision is being made in this conversation.
  2. Confirm the interviewee understands the purpose and, where your policy provides for it, their right to representation.
  3. Explain that contemporaneous notes will be taken and, where applicable, how the record will be used.

Acceptance: the interviewee has heard, in plain terms, what the interview is and is not, before any substantive question is asked.

Step 3: Take the open account

  1. Ask open questions first: “walk me through how you ran this sequence,” “tell me what happened with this batch,” without reference to the specific anomaly yet.
  2. Let the account run without interruption; note what is said and, separately, what is not said.
  3. Ask clarifying, non-leading follow-ups only (“what happened next,” “who else was involved”) before moving to Step 4.

Acceptance: a free account exists in the record, given before any specific document was shown, that can later be compared against the evidence.

Step 4: Introduce the evidence

  1. Show the specific record, timestamp, or reconciliation gap, one item at a time, and ask the interviewee to explain it.
  2. Note where the explanation is consistent with the free account from Step 3 and where it is not.
  3. Do not argue, accuse, or state a conclusion; your role here is to record the explanation and compare it against the documentary record, not to win the point in the room.

Acceptance: each specific piece of evidence shown has a recorded explanation attributed to the interviewee, with the interviewer’s observation of consistency or inconsistency noted separately from the quote itself.

Step 5: Separate the act from the reason

  1. Ask, separately, what was done and why it was done: pressure, unclear procedure, a belief that “this is how it’s always been handled,” a deadline.
  2. Record the reason given as a distinct data point; it feeds the root cause and culture assessment, not the fact of what happened.

Acceptance: the record distinguishes “what happened” from “why,” as two separate, separately evaluated statements.

Step 6: Close without promising an outcome

  1. Thank the interviewee, restate that the matter remains under investigation, and that no decision on outcome or discipline has been made in this conversation.
  2. Do not promise confidentiality, immunity, leniency, or any particular result.

Acceptance: the closing statement in the record contains no promise of outcome, and the interviewee was told the matter is still open.

Step 7: Document and corroborate

  1. Finalize contemporaneous notes the same day, reconciled between the two interviewers.
  2. Weigh the account against the documentary evidence already in hand; a confession is still verified against the data, and a denial does not by itself close a gap the records show.
  3. File the interview record in the investigation file per the parent SOP.

Acceptance: a reconciled, same-day interview record exists in the file, and the conclusion drawn from it cites the documentary evidence it was checked against, not the interview alone.

4. What this work instruction does not cover

It does not determine whether to discipline, terminate, or otherwise act on the interview’s findings; that path runs through your HR and employment process. It does not determine reportability; that is assessed separately per your investigation SOP’s reportability phase, jointly with Legal. It is not a script for a criminal or regulatory interview conducted by an external authority.

5. Records generated

  • Contemporaneous interview notes, reconciled between interviewers.
  • A statement of the free account given, kept distinct from the evidence-driven follow-up.
  • A record of which evidence was shown and the explanation given for each item.

6. Revision history

VersionDateAuthorSummary of change
<<FILL: 1.0>><<FILL: date>><<FILL: author>>Initial issue.

7. Approvals

RoleNameSignatureDate
Author<<FILL>>
Reviewer (QA)<<FILL>>
Reviewer (Legal or HR, per company policy)<<FILL>>

Filled specimen

The scenario is illustrative and invented; it does not describe a real person, company, or case.

FieldEntry
Interviewee roleQC analyst, chromatography
Documentary case going inA re-integration with a blank reason, three months of similar entries on the same instrument, all favorable-direction
Free account (Step 3)Described the sequence as run normally, did not mention any re-integration when asked to walk through it
Evidence shown (Step 4)The specific re-integration record and timestamp; interviewee stated the reason field was “probably just missed”
Consistency noteFree account omitted the re-integration entirely; the omission itself was recorded, not characterized as deception in the notes
Reason given (Step 5)Described a standing informal practice of “cleaning up” borderline results near shift end without being told to stop
ClosingNo outcome promised; matter stated as remaining open pending the root cause and reportability phases

The specimen shows what Step 4’s “note consistency, don’t argue” instruction looks like in practice: the gap between the free account and the record was recorded as a fact, not resolved in the room.

Common inspection findings this work instruction prevents

  • The interview happened before the documentary case was assembled, so it became the source of the facts rather than a check on them.
  • Leading questions handed the interviewee the explanation instead of testing a free account against the evidence.
  • The interviewer promised an outcome or leniency that the company could not or did not honor.
  • Notes were reconstructed days later from memory rather than taken contemporaneously and reconciled the same day.
  • The interview record stands alone with no documented comparison back to the audit trail and reconciliation findings.

How to adapt this work instruction

  1. Confirm with your own Legal and HR functions what your jurisdiction and company policy require for interview conduct, representation rights, and note handling, and fold those requirements into Steps 1 and 2.
  2. Point the “parent SOP” field to your actual data integrity investigation procedure.
  3. If your company uses a standard interview-rights notice, attach or reference it in Step 2.
  4. Keep this work instruction focused on structure and sequence; do not add disciplinary or legal conclusions into the steps themselves.
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