Sample audit report
Fictional example. The company, the people and the numbers below are invented. The structure is the structure of a real HDI audit report.
The company is a cell & gene therapy manufacturer with 11–25 people in operations, the same fictional company as in the example on our homepage. Its free screening gave HDI 63, High Risk. Here is what the full audit added.
Summary
The workshop confirmed the screening and found more dependency than leadership had reported. The verified HDI is 70, High Risk, seven points above the self-assessment. Most of the difference comes from knowledge held by two people: one QA specialist who leads every aseptic-process deviation investigation, and one planner who arranges every manufacturing slot with the treatment centres. The operation spends about 610 hours a month compensating for dependency, about 3.8 full-time people. Four changes, in the order below, address most of it.
Verified score and perception gap
| Screening | Audit | Difference | |
|---|---|---|---|
| HDI | 63 | 70 | +7 |
| Coordination | 58 | 69 | +11 |
| Control | 71 | 73 | +2 |
| Cognitive | 49 | 66 | +17 |
The perception gap is the difference between the screening, which reflects leadership's view, and the score the auditor gave from the workshop. Here it is +7 points overall and largest in the Cognitive layer: leadership saw the investigation and scheduling know-how as documented, and the workshop showed it was not.
Findings
- Deviation investigations wait for one person. Only one QA specialist is trained to lead investigations of aseptic-process deviations, and there is no investigation template. Deviations stay open for 48 days on average; during her two weeks of leave in spring, none closed. Process: Deviation & CAPA.
- Batch records are corrected by hand after review. 34% of executed batch records come back from the first QA review with at least one correction. A supervisor re-checks each record before QA, adding a review step that the procedures do not require. Process: Batch Record Management.
- Manufacturing slots are arranged by email and phone. One planner agrees every slot with the treatment centres; nobody else sees the full picture. It takes 5 business days on average from "patient ready" to a confirmed slot. Process: Patient Scheduling (CGT).
- Chain-of-identity entries are made at the end of the shift. Transfers are noted on paper and typed into the chain-of-identity record later, 6 hours after the transfer on average. Process: Chain of Identity (CoI).
What the dependency costs
The screening estimated about 540 hours a month. The audit measured about 610 hours a month of compensating work: waiting, re-checking, chasing, retyping. That is about 3.8 full-time people, at 160 working hours per person per month.
With a loaded hourly rate of USD 85, agreed with the company's finance lead for this audit, the cost is:
monthly cost = hours per month × loaded hourly rate = 610 × 85 = USD 51,850
Here the loaded hourly rate is the full cost of one hour of an employee's time: salary, benefits and overhead. The rate is the company's figure, not the auditor's.
Priorities
| # | Change | Main effect |
|---|---|---|
| 1 | Investigation template and a second trained investigator; deviations routed in the quality system with due-date alerts | Deviation closure no longer depends on one person |
| 2 | Review by exception for the batch-record steps that produce most corrections; remove the supervisor's extra check | Fewer returned records, one review step less |
| 3 | A shared slot calendar with the treatment centres | Any planner can confirm a slot |
| 4 | Barcode scan at each transfer, written straight to the chain-of-identity record | Entry at the moment of transfer |
Plan and how to track it
- First 30 days: investigation template; second investigator starts training; supervisor check removed after a QA risk assessment.
- Days 30–90: deviation routing and alerts; shared slot calendar.
- Days 90–180: review by exception for batch records; barcode scanning at transfers, through the company's change control and validation.
Four figures track progress: deviation closure time, share of batch records returned at first review, days from "patient ready" to a confirmed slot, and hours from transfer to chain-of-identity entry. The company measures them monthly; a follow-up screening after three months shows the change in HDI.
What else is in a real report
Process-by-process scores, the evidence and quotes behind each score, the assumptions behind every money figure, and the risks of each change. A real report is delivered to the client by the partner who ran the audit.
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