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Quality · eQMSQuality Risk Management (FMEA)

Quality risk management software with RPNs nobody can type in.

Swat iQua Suite quality risk management software keeps FMEA risk registers under document control. The server calculates every risk priority number from severity, occurrence and detection, recalculates residual risk after mitigation and records QA approval with an e-signature.

  • RPN = S × O × D, always server-calculated
  • Residual RPN after mitigation
  • Configurable risk bands
  • E-signed QA approval with SoD
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Risk item lifecycle

Each risk tracked from identified to closed.

The register moves draft → under review → approved → closed. Inside it, each risk item moves identified → assessed → mitigating → residual accepted → closed.

  1. IdentifyFailure mode

    Identified

    The failure mode is recorded in the register for the product, process, change or deviation in scope.

    Identified

  2. AssessS × O × D

    Assessed

    Severity, occurrence and detection scored 1–10; the server calculates the RPN and its band.

    High

  3. MitigateResidual RPN

    Mitigating

    Controls are applied and the residual RPN is recalculated from the new scores.

    Mitigating

  4. AcceptQA e-sign

    Residual accepted

    The remaining risk is accepted, the register approved by QA with an e-signature, and items closed.

    Accepted

Every score, mitigation and approval is in the audit trail, with a reason for each change.

Key capabilities

FMEA software for pharma — kept deliberately simple.

  • Server-calculated RPN

    Risk priority number = Severity × Occurrence × Detection, each scored 1–10. The calculation is always done on the server, so an RPN cannot be typed in or adjusted by hand.

  • Residual risk

    After mitigation the residual RPN is recalculated from the new scores, so the register shows the risk before and after controls.

  • Configurable risk bands

    Bands default to Low ≤ 40, Medium ≤ 100, High ≤ 200 and Critical above that, and can be configured to match your QRM procedure.

  • E-signed QA approval

    QA approves the register with an e-signature. The approver must be different from the preparer and from the item owner.

How it works

A controlled risk register GMP inspectors can actually follow.

Many FMEAs live in spreadsheets where scores can be edited after approval and formulas can be overwritten. In Swat iQua Suite the FMEA risk register is a controlled record: it is prepared, reviewed and approved, and the risk priority numbers in it are always calculated by the system from the scores entered.

Scope of a register

Each register is scoped to a product, process, change or deviation. The scope and method are recorded as descriptive text, so you can reference the change control number, deviation number or process step that the assessment covers. The register is not hard-linked to those records, which keeps it flexible for the way your QRM procedure is written.

From assessment to accepted residual risk

  1. The preparer identifies failure modes and scores severity, occurrence and detection from 1 to 10.
  2. The server calculates each RPN and places it in a risk band.
  3. Mitigations are recorded and the items are re-scored; the residual RPN is recalculated.
  4. QA reviews the register and approves it with an e-signature, accepting the residual risk.
  5. Items and the register are closed when the work is complete.

Where QRM fits in the quality system

FMEA is one of the risk management tools described in ICH Q9. Swat iQua Suite gives you a controlled, FMEA-based register to apply it; your QRM procedure decides when a risk assessment is needed — for example when a change is proposed in Change Control or when a deviation is investigated in Deviation Management.

Quality Risk Management is one of the newer modules in Swat iQua Suite. It focuses on FMEA registers; ask us in a demo how it fits your current QRM procedure.

Regulations

Designed to support a risk-based quality system.

  • GAMP 5

    A risk-based approach to quality decisions, with assessments recorded and approved.

    GAMP 5

  • Revised Schedule M

    Quality risk management as part of the pharmaceutical quality system, documented and approved.

    Revised Schedule M

  • 21 CFR Part 11

    E-signed approval and an audit trail on every score and change.

    21 CFR Part 11

Keep exploring

Related

FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

What is quality risk management software?

Software that records risk assessments as controlled, approved documents. In Swat iQua Suite this is an FMEA risk register with server-calculated RPNs, residual risk after mitigation and e-signed QA approval.

How is the RPN calculated?

RPN = Severity × Occurrence × Detection, each scored from 1 to 10. The server always calculates it, so users cannot enter or override an RPN.

Is this ICH Q9 software?

ICH Q9 describes quality risk management principles and tools, including FMEA. Swat iQua Suite provides a controlled FMEA-based register to support that approach; it does not certify compliance with ICH Q9.

Can we change the risk bands?

Yes. Bands are configurable. The defaults are Low ≤ 40, Medium ≤ 100, High ≤ 200 and Critical above 200.

Can a risk register be linked to a change control?

A register is scoped to a product, process, change or deviation using descriptive text, so you can reference the change control number. It is not a hard system link.

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