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Assured execution driving operational excellence

Operational assurance for regulated operations

Work done to standard, and proven. OpenAcura holds your checks, problems, huddles, actions, procedures and training records in one system, each step signed as it happens. When an inspector asks how a problem was found, owned, fixed and verified, you are not assembling the answer — it is already on the record.

Talk to us Follow one problem through a week

Built for pharmaceutical, medical device, food & beverage, logistics & distribution and industrial operations — anywhere an auditor asks to see the record.

Spreadsheet
RefIssueSevOwnerStatus
1317Temp excursion bay 2MajNKclosed
1318Seal mismatch bay 4MajRob?open??
1319Racking labelMinRDclosed
Email
RE: RE: FW: seal issue bay 4Niamh Kelly → Rob Deane, Jo Nash · Thu 16:48Did this get closed? Auditor is in on the 14th and I can’t find the carrier email.
Paper checklist
✓Trailer temp 2–8 °C
✓Doors & curtain
✗Seal matches manifest
Load released
Chat
Rob DeaneFri 11:02

did anyone actually verify the carrier fix or did we just close it

Whiteboard
Dock huddle · Wed
BAY 4 – SEAL?? C-118
Rob → carrier audit, Fri
✓ temp bay 2   ✗ racking labels
Notebook
Thu – C-118 again?? 3rd time
ask Rob re seals
audit carrier b4 renewal

Where the proof lives today.

Into OpenAcura: signed, owned, evidenced, verified.

The same failure, as one record in OpenAcura.

Built to 21 CFR Part 11 supporting standards ALCOA+ data integrity Electronic signatures Digitally secure audit trail

A week in the life

From the dock to the boardroom.

One problem, followed through a working week at a chilled distribution site. A worked example: every entry below is recorded at the moment it happens, by the person it happens to. Nothing is assembled afterwards.

Marco Ferreira dock operatorNiamh Kelly shift supervisorRob Deane warehouse team leadJo Nash quality leadSarah Whelan operations director

Tuesday

06:40 · Bay 4, inbound

A seal doesn’t match. Marco says so, and OpenAcura records it.

Marco is checking an inbound chilled trailer against its manifest on a handheld. The seal number is wrong. He records a voice note, takes a photograph and holds the load.

Because the check failed, the problem now exists as an issue, with the voice note and the photograph attached to it. Nothing has to be transcribed into a spreadsheet, now or later.

Inspections & checksIssue management
INS-7731Inbound trailer check · bay 4FAILED
Load
Carrier C-118 · trailer 2281 · chilled
Seal
004417 on the trailer · 004471 on the manifest
Voice note
0:14
“Seal’s four-four-one-seven, manifest says four-four-seven-one. Holding it.”
Photo
Seal and door, 06:41
Load status
Held
Signed
M. Ferreira · 06:42 · at the dock
ISS-1318 raised from this check, with the voice note and photo attached.

10:52 · The supervisor’s queue

Niamh decides how serious it is, and signs that decision.

The issue is in Niamh’s queue with the clock already running. She grades it Major and Quality, gives it to Rob and sets Thursday as the deadline.

Triage is signed. Later, there is a record of who graded it and why, rather than a guess.

Issue management
ISS-1318Seal mismatch on inbound trailer · bay 4TRIAGED
Severity
Major
Category
Quality
Owner
R. Deane · due Thu 17:00
Response
Target 8h · met in 4h 12m
Triage signed
N. Kelly · 10:52 · “Carrier seal discrepancy, load held, no product risk found”
Wednesday

07:00 · The shift huddle

The huddle opens with the problem already on the board.

The dock team’s morning huddle follows the same agenda as every day. When it reaches Problems, ISS-1318 is there.

The team decides to audit carrier C-118 against the last sixty days. That decision becomes Rob’s action with a Friday deadline, and the huddle is signed closed with attendance recorded.

5P huddlesActions
T1 Shift HuddleDock team · Wed 07:00 · 15 minCLOSED
Purpose
Safety moment · manual handling in the chiller
People
9 of 11 present · cover agreed for 2
Performance
Dock turnaround 41 min · inbound exceptions 3 this week
Problems
ISS-1318 seal mismatch → create action
Progress
ACT-2194 racking labels · verified
ACT-2210 Audit carrier C-118 against the last 60 days · owner R. Deane · due Fri. Facilitator signed the close at 07:14.

10:40 · The procedure and the person

Which procedure Marco followed, and whether he was qualified to, are already on the record.

Rob starts with the check itself. It was done against SOP-091, Inbound seal verification, at version 3, the version in force on Tuesday. Marco’s competency for inbound checks was valid that day.

Both facts were attached when the check was done. If an auditor asks, they are already on the record.

Document controlCompetency
SOP-091Inbound seal verificationV3 · IN FORCE
Effective
12 May 2026 · approved by J. Nash
Recorded on
INS-7731 at 06:42, as the version Marco was working to
CompetencyM. Ferreira · Inbound trailer checksVALID
Assessed
3 Feb 2026 · observed run · signed by J. Nash
Expires
30 Nov 2026
On Tuesday
Valid · recorded with the check
Thursday

14:22 · The fix, checked by someone else

Rob fixes it. Jo checks that the fix worked. Two people, two signatures.

The carrier confirms the seal was replaced at a cross-dock without telling anyone. Rob adds a seal-transfer step to the receiving checklist and attaches the carrier’s email and the new checklist. He signs the action closed.

Jo, who did none of the work, checks it and signs that it is effective. The audit entry is made before the status changes.

Actions & CAPASignatures
AUD-31207ACT-2210 · closure and verificationSIGNED
Closed by
R. Deane · 14:09 · “Seal-transfer step added to receiving checklist”
Evidence
Carrier email 13 Aug · Receiving checklist v2
Verified by
J. Nash · 14:22 · “Verified effectiveness of corrective action”
Method
Password + PIN · re-authenticated at signing
Record
ACT-2210 · version 2 · this version, no other
Closed by and verified by are different people. The system holds that rule.
Friday

09:00 · The monthly review

Sarah sees this carrier has failed three times in sixty days.

On the operations director’s Quality pillar, inbound exceptions by carrier show C-118 three times in sixty days, each linked to the one before.

Sarah commits, in the review, to audit the carrier before its contract renews in October. Her commitment is an action with an owner and a date, the same kind of record as Marco’s check on Tuesday.

Dashboards & KPIsCommitments
Quality pillarInbound exceptions by carrier · last 60 daysLIVE
Exceptions by carrierfrom INS and ISS records
C-1183
C-0721
C-1311
C-0090
C-118
ISS-1290 · ISS-1302 · ISS-1318 — each linked to the one before
Commitment
COM-0142 Audit carrier C-118 before renewal · owner S. Whelan · due 3 Oct
Twelve weeks later

09:14 · The retailer’s audit

“Show me a seal failure and what you did about it.”

The auditor asks for one example. Rob exports ISS-1318.

The check, the voice note, the photograph, the triage, the huddle decision, the procedure version, the competency, the action, the evidence, both signatures, the carrier pattern and the director’s commitment come out in one file, in the order they happened. It is produced from the record, not assembled for the audit.

Audit trail
Export · ISS-1318Generated 09:14 · one fileCOMPLETE
  1. Tue 06:42INS-7731 check failed · voice note · photo · signed M. Ferreira
  2. Tue 06:42ISS-1318 raised from the check · SOP-091 v3 · competency valid
  3. Tue 10:52Triaged Major · Quality · owner R. Deane · signed N. Kelly
  4. Wed 07:14Reviewed in tier 1 huddle · decision: create action · facilitator signed
  5. Wed 07:14ACT-2210 audit carrier C-118 · owner R. Deane
  6. Thu 14:09Action closed · carrier email · checklist v2 · signed R. Deane
  7. Thu 14:22Verified effective · signed J. Nash · AUD-31207
  8. Fri 09:00Linked to ISS-1290 and ISS-1302 · third in 60 days
  9. Fri 09:31COM-0142 audit carrier before renewal · owner S. Whelan
Added to, never edited. Every entry above was recorded before the change it describes.

However it starts

One loop, whatever starts the problem

It might start with a number: your on-time-in-full drops below what you agreed with a customer, and the system raises the issue and routes it to an owner, instead of waiting for somebody to notice a colour change on a dashboard. It might start with a failed check, a Gemba walk, or an idea from one of your team.

Wherever it starts, it goes round the same loop — found, owned, fixed, checked by someone else, learned from, built into your standard — and you can see where it has got to at any point.

See what happens at each stage

However it startsone loop
DetectSomething’s wronga check, a KPI, a walk, an idea
CaptureIt becomes an issuewith an owner and a date
ResolveThe right-sized fixaction, RCA, CAPA, DMAIC
VerifySomeone else checksevidence, then a signature
LearnThe pattern showsrecurrence and trends
ImproveThe standard changesprocedure, training, strategy

What makes it hold

Three controls you do not have to police

The response fits the problem.

A minor variance gets watched. A fault gets an action. A recurring fault gets a root-cause analysis or a CAPA. Your team does not fill in a ten-page form for a broken label printer, and nobody closes a serious problem with a one-line note.

Completed isn’t the same as effective.

Every action needs evidence, and whoever did the work cannot be the person who signs it off. Where it matters, the system comes back to the fix at thirty, sixty and ninety days to see whether it held.

The people doing the work can see themselves in it.

An idea from your floor becomes a project, you measure the benefit rather than guess at it, and the person who raised it is recognised in front of the team.

The five stages

What happens at each of the five stages

Every stage writes to the same record. See how the five stages connect, or find out where you stand with the maturity assessment.

See

Know what is happening

Resolve

Problems get a verified end

Manage

The huddle drives the day

Execute

The process is controlled

Lead

Leadership routines, demonstrated and recorded

Operational excellence maturity assessment

How mature is your operational excellence system?

Thirty questions about how your organisation sees problems, resolves them, manages performance, executes standards and builds capability. Seven to ten minutes. It tells you which of the five areas to start with, before you talk to anyone.

Take the maturity assessment See what it asks
Maturity profileSample result
61
Level 3 — Standardised
Defined practices and routines, with a lot still moving between them by hand
See55
Resolve68
Manage61
Execute72
Lead49
42Connected index — Fragmented. The practices are stronger than the connections between them.

Next step

We’ll work through a finding you couldn’t answer

Tell us about a finding you struggled to answer, and we will show you how it would look in the record in the platform.

Talk to us Or take the maturity assessment first