A control plan is only as good as the version on the floor. Here drawings, control plans, work instructions, FMEAs and PPAP elements are versioned through an Accepted / Rejected / Deviation lifecycle, and every engineering change runs from request to impact, approval and execution — amending the FMEA and control plan and, where required, triggering a PPAP re-submission. ISO 9001 clause 7.5, without a second system.
A quality document is controlled the moment it is versioned — everything after is change. A change request runs through impact, approval and execution before it touches the FMEA and control plan.
The documents that control production — drawings, control plans, work instructions, FMEAs and PPAP elements — are attached to the item or quality record, versioned, and served from one store. The operator works to the released revision, and a superseded one is retired rather than left in a shared folder to be picked up by mistake. That is ISO 9001 clause 7.5 document control built into the quality system, not bolted on as a separate drive full of files nobody trusts.
Every controlled document carries an Accepted, Rejected or Accepted-Under-Deviation status, so a revision is either released or it is not — there is no ambiguous "latest draft". When something needs to change, it starts as a change request that records what should change, why, and on which part. A tool change, a supplier change, a customer engineering change or a CAPA all enter here, so change is a governed request from the first minute instead of a verbal instruction someone half-remembers.
A change impact assessment works out exactly what the change affects — which documents, which characteristics, which part records — before anything is released. Then change document approval releases the affected documents through the same approval lifecycle, so nothing goes live unsigned. A change dashboard tracks every open change and its impact, so the quality manager sees what is in flight, what is stuck, and what is waiting on whom, instead of chasing status by phone.
An approved change is only real once it reaches the records that control production. So execution amends the FMEA — with an RPN re-evaluation where the risk has moved — updates the control plan for the affected characteristics, and amends the quality plan. And where the change affects a part in a way the customer's rules require to be re-approved, it triggers a PPAP re-submission that reuses the amended FMEA, control plan and package rather than rebuilding them. The change is then reported and closed, so the loop from CAPA or customer change back into the documents is complete and auditable.
Drawings, control plans, work instructions, FMEAs and PPAP elements attached to the item, versioned and served from one place.
Every revision carries an Accepted, Rejected or Accepted-Under-Deviation status, so the released version is unambiguous.
The controlled entry point for every change — a tool change, a supplier change, a customer engineering change or a CAPA.
Scopes exactly what a change affects — documents, characteristics and part records — before anything is released.
Change document approval releases affected documents, and a change dashboard tracks every open change and its impact.
Approved changes amend the FMEA (RPN), control plan and quality plan, and trigger a PPAP re-submission where required.
Most document pain is a folder of near-identical files and a change made by email. A folder is not version control, and an email is not an approval. Here is the difference — and for the wider picture, read what is quality management software?
Controlled documents are the quality documents that must stay current and traceable — drawings, control plans, work instructions, FMEAs and PPAP elements. Each is attached to the item or quality record, versioned, and moved through an approval lifecycle, so the person on the floor always works to the released version and superseded revisions are retired rather than left floating. That is document control for ISO 9001 clause 7.5 without a separate system.
Every controlled document carries an approval status: Accepted (AC) when it is released for use, Rejected (RJ) when it is sent back, or Accepted-Under-Deviation (AD) when it is used under an approved concession. Because the same AC / RJ / AD lifecycle governs drawings, control plans, FMEAs and PPAP elements, a document is either the approved current version or it is not — there is no ambiguous "latest draft" in circulation.
Change runs as a controlled sequence: a change request captures what should change and why; a change impact assessment works out what it affects; change document approval releases the affected documents; and the change is then executed and reported. A change dashboard tracks every open change and its impact, so an engineering change or a customer-driven change is a governed process rather than an email and a verbal instruction.
An approved change flows back into the core-tool records it affects. It amends the FMEA — including an RPN re-evaluation where the risk has changed — and updates the control plan for the affected characteristics, and it can amend the quality plan. So a fix that came out of a CAPA, a deviation or a customer change is designed into the documents that control production, not just noted once and forgotten.
When an approved change affects a part in a way the customer's PPAP rules require to be re-approved — a design or process change, a new source, or a control change on a special characteristic — the change triggers a PPAP re-submission. Because the FMEA, control plan and PPAP package already sit on the same platform, the re-submission reuses the amended records instead of being rebuilt from scratch.
Live demo of the document-and-change path — controlled documents, the AC/RJ/AD lifecycle, a change from request to re-PPAP — on a part like yours. Cloud or on-premise, no generic slideshow.
