Quality Management & Non-Conformance

The problem you are actually paying for

Dynamics 365 Supply Chain Management ships real quality functionality — quality associations, quality orders, test groups, quarantine orders, non-conformances. For a manufacturer with straightforward incoming inspection, that is often enough.

It stops being enough the moment you are regulated, audited, or selling into customers who impose their own quality terms. Then the gaps are specific and expensive. There is no statistical sampling plan, so your inspectors either test everything or apply an AQL table from a laminated card and record a decision the system cannot justify. There is no certificate of analysis, so a batch ships with a document assembled in Word from test results copied off a screen. Supplier quality lives in a spreadsheet that one person maintains, so vendor performance never reaches the sourcing decision. And a non-conformance records that something went wrong without ever driving a corrective action to closure — the CAPA loop runs on email and meeting minutes.

When an auditor asks you to demonstrate that a corrective action from eight months ago was implemented and verified effective, that spreadsheet is not an answer.

What ECOSIRE builds

This is a build-to-order engagement. We extend what F&O already gives you rather than replacing it, so quality orders, test groups and quarantine handling continue to work as your team knows them.

Sampling plans and AQL

We build sampling plan master data — plan tables, inspection levels, acceptance and rejection numbers — and wire it into quality order generation so that sample size is derived from the actual lot quantity and the plan assigned to the item, item group, vendor or test group. Switching rules between normal, tightened and reduced inspection are driven by inspection history rather than by an inspector's judgement, and every accept or reject decision records which plan and which acceptance number produced it. That record is what makes the decision defensible in an audit.

Certificate of analysis

A CoA layout is built against your customer and regulatory requirements, populated from the actual quality order results for the batch being shipped: test names, specifications, measured results, method references, batch attributes, disposition and authorised signature. Generation is triggered from the sales flow — at packing slip, at invoice, or on demand — and the produced document is archived against the batch so a reprint years later returns the certificate that was actually issued rather than a regenerated approximation. Where you need a customer-specific layout or language variant, that is master data rather than a code change.

Supplier quality scorecards

We build scorecard master data with weighted criteria you define — incoming inspection pass rate, non-conformances raised, on-time delivery, response time on corrective action requests, and any manual assessment criteria your quality team scores directly. A batch job recalculates scores on your chosen period, and the resulting rating is surfaced on the vendor record where sourcing and procurement can see it. Where you want it to have teeth, the score can gate approved-vendor status through the standard vendor approval mechanism, so a supplier that has stopped performing stops receiving purchase orders.

Non-conformance and CAPA

This is the heart of the extension. We extend non-conformance handling into a full corrective and preventive action lifecycle running on the F&O workflow framework:

• Non-conformance raised from a quality order failure, a production scrap event, a customer complaint or manually, with the source document linked.
• Containment actions with owner and due date, recorded before the investigation begins.
• Root cause analysis with your chosen methodology and a defined cause category taxonomy so causes can be reported on rather than read.
• Corrective and preventive actions as tracked tasks with owners, due dates and escalation through workflow when they age.
• Effectiveness verification as an explicit, separately owned step — a CAPA cannot be closed because someone marked it done, only because a verifier confirmed the action worked.
• Approval and closure through workflow with full history retained.

Every state change is recorded with user, timestamp and comment, and the record is immutable once closed.

Analytics and audit evidence

The extension exposes its data through data entities over OData so your existing Power BI reporting can consume it alongside the rest of F&O. Standard views we build cover open CAPA ageing by owner, non-conformance Pareto by cause category, supplier score trend and inspection pass rate by item group. For audits, we build a document pack export that assembles the full evidence chain for a given batch or CAPA — inspection results, sampling decision, certificate issued, non-conformances raised and actions closed — into a single retrievable set.

Where quality touches the rest of F&O

Blocked and quarantined stock continues to use standard inventory blocking and quarantine orders. Batch disposition drives batch attributes so that batch-attribute-based reservation and picking respect the quality status. Where you use advanced warehouse management, inspection and disposition steps are reflected in the warehouse mobile app flow rather than requiring the inspector to leave the floor for a desktop client. Ledger impact from scrap and rework dispositions posts through your existing configuration and ledger dimensions.

Who this is for

Regulated and quality-critical manufacturers — food and beverage, pharmaceutical and nutraceutical, chemical, medical device, automotive and aerospace suppliers — running F&O and holding a certification or customer quality agreement that base quality orders cannot evidence on their own. It is worth most where you are audited, where you issue certificates with shipments, and where supplier quality genuinely affects sourcing.

If your quality process is a visual check on receipt and nobody outside your business ever asks you to prove it, the standard functionality is likely sufficient and we will say so.

How delivery works

1. Scoping call. We review your current quality configuration, your certification requirements, your CoA content obligations, your supplier evaluation criteria and your existing CAPA process — including how it runs today outside the system. 2. Fixed quote and specification. A written functional and technical specification and a fixed price. Scope changes are quoted before they are built. 3. Build. X++ extension model against your version and configuration, no overlayering. Typical lead time two to four weeks, longer where CoA layouts are numerous or CAPA workflow is deeply customised. 4. Install in test. Deployable package into your sandbox through LCS. You validate against your own items, batches and vendors. Where you are in a validated environment we deliver the documentation your validation protocol requires and support your IQ/OQ execution — your quality function owns the validation itself. 5. Production. Promotion through your normal release process, with us available for the go-live. 6. Support. A defect support window with a named contact after go-live.

What we will tell you honestly

We build software that helps you evidence a quality system. We do not certify you, we hold no accreditation on your behalf, and no vendor's software makes an organisation compliant by itself. Your procedures, your training and your discipline do that — this gives them a system of record that stands up when someone asks for proof.