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Quality and compliance

Quality processes with complete documentation

In this field a process doesn't just have to work. You also have to be able to show that it worked, with the time, the owner and the reason. That is hard to achieve with spreadsheets and email threads, and it is exactly what certifications examine.

  • Complete traceability
  • Actions tracked to closure
  • Reports available at any time
  • Sensitive reports can be separated

The core

Records are created within the process itself

If a process runs partly in a system and partly in inboxes, the records have gaps, even if the system part is well documented. What matters is that the entire flow happens in the system: finding, assignment, query, deadline extension, effectiveness check, closure. That requires a tool that maps the process the way it actually runs.

Today and tomorrow

From audit preparation as a project to reports on demand

Today

Hunting for evidence

Before every audit, the search begins: who closed the action, when, and where is the proof?

  • Action list in a spreadsheet, status unclear
  • Deadline extensions by email, no reason given
  • Documents in folders, acknowledgement unknown
  • Complaint costs never brought together
  • Sensitive reports in one person's inbox
With nexxcite

Records are created automatically

Every step happens in the system, with time, person and reason. The audit report is a query rather than a project of its own.

  • Actions with owner, deadline and escalation
  • Deadline extension as a documented decision
  • Acknowledgement recorded per person
  • Costs and causes analysable per complaint
  • Sensitive reports fully separated

Typical processes

The processes auditors look at

Processes where the records count as much as the workflow, linked across suppliers, products, equipment and training.

Audits and actions

This process shows whether quality management is part of daily work: what happens after the finding? Audit planning with scope, date and participants, findings with rating and evidence, actions with owner and deadline, and an effectiveness check as a step in its own right.

  • Audit planning
  • Findings
  • Actions
  • Effectiveness
  • Escalation

Complaints and 8D

From report through root-cause analysis to corrective and preventive action, linked to supplier, batch and equipment.

  • Containment
  • 8D report
  • Costs

Document control

Approval, version, validity and acknowledgement. Companies often buy a separate tool for this.

  • Version
  • Acknowledgement

Whistleblowing and data breaches

Reporting channels through a dedicated portal, anonymous if needed. Deadlines run from the date of awareness, and only the responsible office has access.

  • Anonymous
  • Deadlines

Risks and incidents

Assessment, action and closure documented, with reports for your disclosure obligations.

Training records

Who is qualified for which task, and when does it expire? Linked to documents and processes.

See HR processes

In depth · audit and action

From audit finding to verified effectiveness

An internal audit in production finds that test equipment isn't consistently calibrated. What happens next decides the next external audit. Deadlines are examples.

  1. 01

    The finding is recorded

    Directly on the audit, with rating, affected area and photos as evidence. Nobody has to type up a report afterwards.

    • Rating
    • Evidence
  2. 02

    Actions with clear ownership

    The production manager gets the corrective action with a deadline, quality gets the preventive action. Every action knows its finding, every finding its audit.

    • Owner
    • Deadline
    • Linked
  3. 03

    Extensions with a reason

    If time runs short, the owner requests an extension. Quality decides, and the decision is recorded on the case with its reason. Without a request, the case is escalated.

  4. 04

    The effectiveness check

    A completed action isn't necessarily an effective one. After a set period, a check is created automatically to see whether it worked. Only then is the finding closed.

    • A step of its own
    • Follow-up
  5. 05

    The next audit starts with a report

    Open, overdue and effectively closed actions per area are available as a view, without exporting data.

AI in quality and compliance

Quality builds its own processes, with AI to help if wanted

When setting up: your team builds complaint handling in the editor, with sales recording the complaint, quality reviewing it and an 8D report for repeat defects. If you wish, the assistant takes over the implementation from a description like this: data model, form, a workflow with deadlines in working days, a rule for repeat defects, the quality assurance role and a dashboard by cause. Everything goes into a draft first, each change with its origin.

In this field that matters: every change records which AI request it came from. Anyone who later wants to know why the process is set up this way can trace it.

Day to day: asked “Which actions from the last audit are overdue?”, the assistant returns a grouped list. It summarises long complaint histories and answers questions from your manual and your work instructions.

  • Processes from a description, always in a draft and reversible
  • The origin of every change is traceable
  • Open actions analysed in plain language
  • Summaries of long cases
  • Answers from internal knowledge such as manuals and procedures
  • The assistant sees only what its user may see

In depth · complaint

When a defect recurs, an 8D report starts

A customer complaint comes in, and the platform recognises that it isn't the first of its kind. The threshold is an example from a configuration.

  1. 01

    Captured through several channels

    Sales records the complaint in the form, or it arrives via portal, mailbox or interface. Either way, it is linked to customer, product and batch.

    • Portal
    • Mailbox
    • Interface
  2. 02

    Containment first

    Block, sort, replace: containment runs separately from root-cause analysis, so urgent steps don't have to wait for the detailed analysis.

  3. 03

    The rule spots the repeat defect

    If the same defect occurs three times within 30 days, an 8D report starts automatically and quality assurance gets the task.

    • Rule
    • 8D automatically
  4. 04

    Cause, correction, prevention

    Each 8D discipline with owner and deadline. If the supplier is the cause, the complaint sits on the supplier record and feeds into their next evaluation.

  5. 05

    Costs and causes analysed

    Cost per complaint, Pareto by cause, trend by supplier and period, each as a view on the same data.

    • Pareto
    • Trend
    • Costs

Your own workspace

Sensitive cases are seen only by the responsible office

Whistleblowing, data breaches, incidents involving personal data: here, trust in the whole process depends on who has access. On nexxcite, especially sensitive cases can be fully separated so that only the responsible office sees them.

Quality and compliance get a workspace of their own, with their own roles, navigation, a home page with open actions and running deadlines, and their own assistant. For everyone else, the workspace isn't there, neither in navigation nor in search nor through the interface.

An auditor can be given a role that reads exactly the cases within the audit scope and nothing else.

  • Read limits per type of data as a rule
  • Field permissions for especially sensitive details
  • Own roles, navigation and home page
  • Assistant can be limited to the workspace
  • Retention periods as rules
  • One permission check for user interface, portal, interfaces and AI

Integration

Connected to your existing systems

ERP and production

Suppliers, products and batches come from your system of record, so complaints and actions are attached to the right object.

  • Secured interface
  • Calls to other systems
  • Common data formats

Report intake

Complaints and reports from monitored mailboxes, notifications to the people responsible.

  • Exchange Online
  • IMAP and SMTP

Evidence and data

Photos, reports and records in your own storage, with legacy data taken over from spreadsheets.

  • Storage in Azure or Amazon S3
  • Excel and CSV
  • Schedules

What nexxcite is not

nexxcite is not a certified quality management system and doesn't ship with templates for any particular standard. What it brings is the means to model your standard-compliant way of working and make it provable.

If you're looking for a product that already implements a standard out of the box, a specialist system is the shorter route. If you already have one and it doesn't fully cover your workflows, the remaining processes can be mapped with nexxcite.

Objections

What quality managers want to know up front

Does nexxcite come with templates for a standard?

No. nexxcite maps your own way of working. Your team builds the process in the editor. If you wish, AI sets up a first version from your description, which your team reviews and approves. The result is a process that fits your management system.

How do we prove who changed what, and when?

Every step in a case is recorded on the record with time, person and reason. Changes to the configuration itself go through drafts that are approved together. If AI proposed a change, that is recorded too.

Can reports be submitted anonymously?

Yes. Reporting channels can be set up through a dedicated portal, anonymous if needed. Deadlines run from the date of awareness, and only the responsible office has access.

We already have a QM system. Why another platform?

If it covers your workflows completely, you don't need one. Often it covers the standard but not action tracking across departments, the supplier side or the reports alongside. That is where gaps in the records appear.

Where does the data live?

Wherever you decide: as SaaS, in your own data centre or in a private cloud. Switching operating models later doesn't mean rebuilding.

Can the AI access confidential cases?

Only if its user can. Whatever the permission check filters out, the assistant doesn't see. On top of that, you decide per assistant which data areas it knows at all.

Live demo

We'll rebuild your action process in the demo

How long your audit preparation takes today is a good indicator of how completely your processes already run in the system. Show us your action process, and we'll rebuild it with you in the demo.

  • Your process, not a sample
  • Built live, in the editor or with AI
  • Remote or on site