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Solution · Operations & qualityFrom a photo taken on the line to a closed CAPA with evidence behind it
Non-conformances and CAPA handled in Teams
Every non-conformance is registered, classified and routed the moment it is raised; containment, supplier 8D requests and effectiveness checks run to due dates instead of reminders.
Executive summary
Containment, root cause, supplier 8D and effectiveness checks live in one spreadsheet and three mailboxes.
We build one intake, one register and one clock.
Containment starts within minutes instead of at the next quality meeting, so less material moves after the defect is known.
SAP S/4HANA QM (notifications, batch status); the Microsoft Lists register; the SharePoint evidence library
Business problem
Quality management
The process exists for a serious reason. In a regulated quality system every non-conformity has to be recorded, the material contained, the cause investigated, the corrective action taken, and somebody has to come back later and confirm the action worked. That is not bureaucracy. It is the mechanism that stops a defective batch reaching a patient, a car or a shelf.
What breaks is the plumbing around the thinking. The report is an email, the register is a spreadsheet, containment is a phone call, the ERP notification is created by whoever remembers, and the supplier 8D request sits in a buyer's Sent Items. Three functions own pieces of one case: quality investigates, production contains, purchasing negotiates. Nobody owns the chain, so an engineer holds it together by chasing.
At this volume the chasing becomes the job. The tracker is only as current as the last person who updated it, so the monthly quality figure is argued about rather than read, and 8D requests drift because nothing enforces a due date. The first casualty is the effectiveness check, the review 60 to 90 days after closure that asks whether the fix held: by then the case feels finished and no calendar says otherwise. Engineers spend expensive hours on administration instead of prevention.
How it works today
A non-conformance travels from a photo in a mailbox to a row in a tracker, and it takes the same route in most plants before automation, whatever the quality system on the label.
- PersonAn inspector reports the non-conformance by email to a quality mailbox with photos, a batch number and free text
- PersonAn engineer works through the mailbox, numbers each report and builds a tracker row from what can be reconstructed
- WaitingClassification waits for the next quality meeting; meanwhile the stock is blocked informally, by a message to the shift leader
- SystemSomeone blocks the batch in SAP and someone else updates the quality record; the two versions do not always agree
- PersonSupplier cases go to purchasing, which emails the supplier asking for an 8D; the due date lives in the sender's memory
- WaitingCorrective actions sit in the same spreadsheet, and owners learn they are overdue at the monthly quality review
- Risk of errorThe effectiveness check is rarely performed, so a case closes without anyone confirming the defect stopped recurring
Why the current process costs more than it appears
The bill that never reaches the budget.
- Coordination is the invisible line item. Every report starts a chain of "who owns this", "was the batch blocked", "did the supplier answer" that nobody records and everybody pays for.
- Containment that arrives late is the expensive kind. Material keeps moving while the decision is made, so a two-hour delay turns a rejected pallet into a rework order or a customer notification.
- Supplier 8D requests without a system are requests without a deadline. Purchasing chases when it remembers, suppliers answer the loudest buyer, and the defect returns next quarter.
- Two records of one case, one in the spreadsheet and one in the ERP, produce a monthly figure that has to be defended before it can be discussed.
- Auditors do not test whether people work hard. They test whether the loop closes, case by case, with evidence. A corrective action closed without a documented effectiveness check is a finding.
Cost of inaction
The pool above is only the part that prices cleanly. Next to it sits time-to-containment, which does not scale linearly: a batch that keeps moving for a shift after a defect is known is the difference between a rejected pallet and a rework order, and occasionally between a rework order and a customer notification.
The second exposure is documentary. A corrective action closed without a recorded effectiveness check is not really closed, and the gap is found by an auditor rather than by the company. Each year the manual method continues, more case histories live in mailboxes and the clean-up becomes a project nobody planned.
A plausible organisation with realistic proportions. The figures are there to be recalculated on your data; they are not a client result.
A European medical-devices manufacturer with three plants, around 1,400 employees and an ISO 13485 certified quality system; SAP S/4HANA with the QM module, Microsoft 365 E3, eleven quality engineers across the sites.
320 non-conformance reports a month from incoming inspection, in-process checks, final inspection and distributor returns; roughly a third are attributable to a supplier and should become 8D requests.
Reports arrive as email with photos. An engineer numbers them and keeps the tracker, containment is agreed by phone, quality notifications reach SAP for some cases, and corrective actions are reviewed once a month.
About 50 minutes per report of pure coordination: numbering, retyping, chasing owners, asking purchasing about supplier replies, reconciling the tracker with SAP and building the monthly pack. Investigation sits on top and stays with the engineers.
Reports are raised on one form, classified by rules, and turned into containment, investigation and 8D tasks with named owners and due dates. Robots write the quality notification, set the batch status, chase the supplier and reopen the case for its effectiveness check.
Coordination per report drops from 50 minutes to under 15, containment reaches the shift leader within minutes, and every closed CAPA carries a documented effectiveness check because the flow will not close without one. Illustrative, not a client result.
Proposed solution
We build one intake, one register and one clock. Whoever finds the defect reports it where they stand: a Microsoft Forms form on a shop-floor tablet, or the same form in Microsoft Teams from a phone, photos attached in the moment. The response becomes an item in the register in Microsoft Lists, the photos land in a SharePoint library with version history, and the case has a number, a state and an owner.
Classification is deterministic on purpose. Defect code, detection point, product family, batch and supplier are structured fields, and rules written against them set the severity, the containment steps, the notifications and the due dates. A quality manager can change those rules and an auditor can read them. Nothing here needs a model, which is the right trade in a system that must be justified, not merely accurate.
Robots then do what fills an engineer's afternoon today. They create the quality notification in SAP S/4HANA QM with its defect coding, set the batch status, and write the notification number back so the two records cannot drift apart. Supplier cases get an 8D request with the evidence and a due date, then an escalation calendar nobody has to run. Closure schedules the effectiveness check, and when it falls due the case reopens as a task. People meet all of this in Microsoft Teams: containment as an Action Center task, disposition and CAPA through the Approvals app, a digest built from the register.
Microsoft Forms responses as a Power Automate trigger; Microsoft Lists register with rules and versioning; Microsoft Teams Approvals app; Adaptive Cards through the Workflows app; UiPath Orchestrator queues and triggers with audit; UiPath Action Center tasks inside Microsoft Teams; UiPath Integration Service list-item triggers; SharePoint versioning with Microsoft Purview retention labels
The state model, the classification and routing rules, the containment task set per defect category, the 8D pack and its escalation calendar, the SAP QM write and write-back logic, the effectiveness-check scheduler, the evidence pack
SAP S/4HANA Quality Management notifications and batch status through UiPath SAP activities (BAPI/OData); the supplier email or portal channel where no interface exists
How the automated process works
- AutomationA submitted report creates the register item in Microsoft Lists, files the photos in SharePoint and raises a queue item in UiPath Orchestrator
- SystemRules classify by defect code, detection point, product family and supplier, set the severity and select the containment steps
- AutomationA robot creates the quality notification in SAP S/4HANA QM, sets the batch status and writes the notification number back to the register
- PersonThe containment task reaches the shift leader in Teams with the photos and the batch on the card; they confirm what was blocked and where it is
- AutomationSupplier cases generate the 8D request with the evidence and a due date; reminders and escalation to the buyer run to the calendar
- PersonThe corrective action and its closure are approved in Teams by the quality manager, with regulatory affairs added when a registered product is touched
- AutomationClosure schedules the effectiveness check; when due the case reopens with its original evidence, and the daily Power BI pack shows open cases by age, containment lead time and supplier response
Human-in-the-loop model
Automation handles
- Registration, numbering, classification by rules and the SAP quality notification with its defect coding
- Task creation with owners and due dates: containment, investigation, corrective action, effectiveness check
- Supplier 8D requests, reminders, escalation and the record of what was sent and when
- The evidence pack and the reporting: photos, decisions, timestamps, versions, audit trail
People decide
- Severity, and whether the case reaches product already released
- Root cause and the corrective action; a rule can route an investigation, it cannot conduct one
- Whether a supplier's 8D answer is accepted and whether containment can be lifted
- Closure, including the judgement on whether the effectiveness check passed
Before and after
Systems and integrations
The stack is deliberately short: one engine, one execution layer, one place where a person decides.
Inputs
- the Microsoft Forms report from the line
- the same form in Teams from a phone
- incoming-inspection results in SAP QM
- distributor returns by email
Automation layer
- UiPath Orchestrator
- UiPath Robots
- UiPath Integration Service
- UiPath Action Center
- Power Automate
Target systems
- SAP S/4HANA QM (notifications, batch status)
- the Microsoft Lists register
- the SharePoint evidence library
- the Power BI quality model
Human touchpoints: Action Center tasks in Microsoft Teams; Teams Approvals for disposition and CAPA; the quality channel digest
Technologies used
the intake form used on the line and the register holding every case, its state, owner and due dates
Acarries the response into the register, files the photos, posts the Adaptive Card to the quality channel
Alist-item triggers start the automation on registration or a state change
Aapply the rules, write to SAP, run the escalation calendar, hold the queue and the audit log
Acontainment, investigation and effectiveness-check tasks completed inside Teams
Adisposition and CAPA approvals with evidence attached and audit events in Microsoft Purview
Aquality notifications, defect coding, batch status
Athe quality pack: open cases by age, containment lead time, supplier 8D response, CAPA effectiveness
AIllustrative economic model
Numbers you can check against your own data.
The model counts coordination only, not the investigation, which stays with the engineers: the 50 minutes covers numbering, retyping, chasing, reconciling the tracker with the ERP and preparing the monthly pack. Those minutes are an illustration built from typical ranges, not a measurement from a client. €34 is a fully loaded hourly cost for a quality engineer in Central Europe. We price the whole coordination pool; in the modelled case the flow absorbs roughly two thirds of it.
Run the numbers on your data
An illustrative estimate from your own inputs. It models released capacity; it is not a promise of savings.
Business benefits
- Containment starts within minutes instead of at the next quality meeting, so less material moves after the defect is known
- Every case has one number, one owner and one due date from the moment it is raised; the mailbox stops being the system of record
- Supplier 8D requests carry a deadline the system remembers, and repeat defects become visible per supplier and per part
- Effectiveness checks happen because closure schedules them, which turns a step people forget into a step the flow requires
- The ERP and the quality register agree, so the monthly figure is read rather than reconstructed
- Quality engineers spend their hours on investigation and prevention, the work the certificate actually rests on
The management view
- Quality performance stops being a monthly retrospective: open cases, ages and overdue actions are visible on the day, per site and per product family
- Supplier quality becomes a negotiating position backed by response times, repeat-defect counts and their cost
- Audit preparation changes character: the evidence for any case is assembled from the record rather than rebuilt from mailboxes
- The process survives holidays, resignations and a fourth site, because the rules and the calendar sit in the flow
Board-level KPIs
Security and governance
Where the data sits and who can see it.
- Robots hold their own SAP accounts, limited to quality notifications and batch status; secrets stay in the platform credential store, not in the workflow
- The register, the photographs and the approval history remain in your Microsoft 365 tenant, and the automation runs in the UiPath Automation Cloud EU region
- Disposition and CAPA approvals follow your authority matrix, and whoever raised a case cannot approve its closure
- Every state change records who acted, when and on what evidence; documents are versioned in SharePoint and retention is governed with Microsoft Purview labels
- Classification rules and due-date policies are versioned and released through a controlled path, because they are quality-system content
Why now
ISO 13485:2016 requires documented control of non-conforming product and corrective action that includes a review of its effectiveness; the certificate turns on evidencing that loop case by case
Every re-sourced supplier restarts the 8D learning curve, and a process held together by one engineer's memory does not survive that turnover. It costs the modelled €9,067 a month
Nothing here needs a model or an agent: Forms, Lists, Approvals, Adaptive Cards through the Workflows app and list-item triggers in UiPath Integration Service ship with licences most manufacturers hold
Relevant executive roles
Containment speed decides whether a defect costs a pallet or a production week; the flow makes it a setting rather than a question of who was available
The certificate rests on evidenced containment, investigation and verification, built while the work happens rather than before an audit
Response times, repeat defects and their cost become measurable per supplier and per part, before the next negotiation
Common questions and objections
The register, the tasks and the calendar sit around your quality system rather than inside it. Where the flow writes to a validated system, here the quality notification and batch status in SAP, we deliver the qualification evidence for that interface. Defined scope, and far smaller than revalidating the system.
Rules do not investigate, they classify and route. Defect code, detection point, product family and supplier decide who is notified, which containment applies and what the due dates are. Everything after that is human judgement, recorded in the same case.
The request goes out the same day with a due date, the reminder does not depend on a buyer remembering, and non-response becomes a figure in the supplier scorecard. Escalation is a calendar entry, not a decision someone has to take.
When this is not the right solution
- A few dozen reports a month handled by one engineer, where a well-kept list and a weekly review cost less than the flow
- No defect catalogue and no agreed severity rules; classification has to be settled before it can be automated, and that is a quality project
- Non-conformances are not reported at all; under-reporting is a culture and measurement issue that a faster register will not fix
A question for the next management meeting
For the non-conformances we closed last quarter, how many can we evidence a completed effectiveness check for, and how long did each wait before containment started?
Implementation approach
A scope without ambiguity, before anything is signed.
We deliver
- A pass over three months of history: sources, defect categories, supplier share, ages and what "closed" means today
- The register in Microsoft Lists with the state model, owners, due dates and the fields your quality system needs
- Classification and routing rules per defect category, severity and product family, written so an auditor can read them
- SAP QM notification and batch-status automation with error handling and write-back into the register
- The 8D request pack, its escalation calendar and the supplier response record
- Teams touchpoints: containment tasks, disposition and CAPA approvals, the quality channel digest
- The Power BI quality model and the qualification documentation for the interface we build
We need from you
- Three months of history with the current tracker and the matching SAP quality notifications
- A process owner in quality, plus a named contact in production and in purchasing
- Your defect catalogue, severity rules and disposition authorities
- Technical accounts for SAP test and production and for the Microsoft 365 tenant
Stages
Discovery
Sources, defect categories, volumes, owners and the path a report really takes today
Design
State model, classification rules, task sets, escalation calendar, security model
Build
Register, robots, SAP QM integration and the Teams touchpoints in your environment
Validation
Replay of historical cases, exception handling and the qualification evidence required
Go-live
One site and one defect family first, under supervision, with hypercare
Optimisation
Rule tuning, supplier scorecards, extension to the remaining sites
Departmental. Effort is driven by the number of sites and defect categories, how far SAP QM is genuinely used today, and the qualification evidence your quality system asks of a controlled change.
The line keeps running while quality decides what the photograph actually shows.
Send us last month's non-conformance list, your defect catalogue and one 8D request you issued to a supplier. You get back a target state model, the classification rules it implies and a first estimate of the coordination hours involved.
Time one non-conformance with usThe neighbouring process usually has the same problem
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