Straight answers on APQP and PPAP, FMEA and control plans, inspection and SPC, NCR and 8D/CAPA, gauge R&R and calibration, and controlled documents and change — the six pillars of an IATF 16949 / ISO 9001 quality system, written by the team that builds Fast Quality Software.
APQP — Advanced Product Quality Planning — is run as timing-gated stages, not a single form: plan and define, product design, process design, product and process validation, and feedback. Each gate has an owner, a target and actual date and a status, so it is explicit whether the gate is met, and a program dashboard shows every open part with its current stage, % complete and any overdue gates. See APQP & PPAP.
PPAP assembles the elements that prove a part is approved for mass production — design records and drawings, engineering change docs, DFMEA/PFMEA, process flow, control plan, MSA/Gauge R&R studies, dimensional and material/performance results, initial process study (SPC), qualified lab docs, appearance approval, sample parts, checking aids, customer-specific requirements, and the PSW. Every element is a controlled document, so the package stays version-controlled and auditable. See APQP & PPAP explained.
The PSW — Part Submission Warrant — is the summary sign-off sheet of a PPAP package: it declares that the part meets all customer requirements and states which submission level (from level 1 warrant-only up to level 5 full review at the supplier) applies. The PPAP dashboard tracks each part's status and level, and approval moves the PSW to Accepted, releasing the part for mass production. See APQP & PPAP.
Before the APQP stages run, a feasibility commitment records whether the plant can manufacture the part to the drawing, tolerance and volume; a feasibility approval signs it off. That sign-off is what opens the APQP program, so no part enters detailed planning until manufacturing feasibility is agreed. From there the APQP outputs — FMEA, process flow, control plan, MSA plan — become the inputs to PPAP with no re-keying. See APQP & PPAP.
DFMEA analyses design failure modes; PFMEA analyses process failure modes. Both score each failure mode by severity × occurrence × detection to give the RPN — the Risk Priority Number — on a 1–10 scale per factor. A high RPN flags a mode for action, and its special characteristics are carried onto the control plan. See the FMEA & control plan guide.
A control plan is the reaction plan that says, for each characteristic: what to measure, with which gauge, at what frequency, by what method, and what to do on non-conformance. It is built from the specification master — nominal, tolerance and criteria per item and process — links each characteristic to a gauge from the gauge register, and is a mandatory PPAP element. See FMEA & Control Plan.
A special or significant characteristic is a feature whose variation materially affects safety, fit or function. It is flagged from the FMEA, controlled with tighter frequency and method on the control plan, and prioritised in SPC. Because the same characteristic is linked to a defect code, when that defect later appears on the line the trace back to the FMEA is intact. See FMEA & Control Plan.
The specification master defines what "good" means: nominal, upper and lower specification limits (USL/LSL) and acceptance criteria per item and per process characteristic. It is the single source both inspection and SPC read — inspection records readings against it, and SPC evaluates capability against the same limits — so a control plan, an inspection result and a capability chart all speak the same numbers. See FMEA & Control Plan.
Inspection runs at four points: incoming (against the GRN), in-process (during manufacture), final, and pre-dispatch before shipping. Each stage reads the specification master to know what to check, records variable and attribute readings against tolerance, and dispositions the lot. The inspector dashboard shows pending inspections, allocated lots and today's dispositions in one place. See Inspection & SPC.
They are the three dispositions. AC is Accepted — the lot conforms and stock is released. RJ is Rejected — non-conforming, which raises an NCR. AD is Accepted Under Deviation — non-conforming but accepted through an approved, time or quantity bound concession. Incoming inspection against the receipt ties the result to the store receipt, so accepted and rejected quantities move real stock. See Inspection & SPC.
Cp and Cpk are process-capability indices. Cp compares the spread of the process to the width of the specification (USL–LSL); Cpk also accounts for how well-centred the process is between the limits. SPC is driven off the same specification limits the control plan uses — inspection readings are evaluated against nominal, USL and LSL, and capability and control charts are rendered to keep a process in statistical control. See Inspection & SPC.
Inspection against receipt pulls the received quantity straight from the store receipt (GRN), so results are booked against the real GRN line rather than re-keyed. The accepted quantity is released to stock, the rejected quantity raises a material rejection against the supplier, and any accept-under-deviation quantity is recorded with its approved concession — one disposition, correctly split. See production & inspection integration.
Both are NCRs — non-conformance reports — but at different points. Material rejection is the incoming/supplier NCR raised against a GRN, tagged with the defect code and supplier, and it drives supplier-claim reporting. Line rejection is the in-process NCR booked against the work order and process, with child-part rejection for assemblies. A rejection Pareto by defect, process or part shows where non-conformance concentrates. See NCR, Rejection & 8D/CAPA.
8D is an eight-discipline corrective-action report: D1 team, D2 problem description, D3 containment, D4 root cause, D5 permanent corrective action, D6 implement and validate, D7 prevent recurrence, D8 close and recognise. An 8D is opened from a major NCR or a customer complaint, captures root cause and the CAPA, and feeds back into the FMEA and control plan. See the 8D & CAPA guide.
CAPA — corrective and preventive action — is the action set that fixes a root cause and prevents recurrence. It is driven through change management, which amends the FMEA (re-evaluating RPN) and the control plan and, where required, triggers a PPAP re-submission. That is the closed loop: inspection → NCR → 8D → CAPA → change → re-PPAP, every step auditable. See complaint → 8D integration.
A minor NCR can be dispositioned as accept-under-deviation via an approved concession, or sent to a controlled rework sub-process: a rework process sheet defines the salvage operations, rework status tracks execution with its own good and reject, and salvaged parts either transfer to finished goods or return to the main flow. A major or recurring NCR escalates to an 8D instead. See NCR, Rejection & 8D/CAPA.
The gauge master is the register of every measuring instrument: gauge code, type (vernier, micrometer, plug gauge, CMM, height gauge and so on), least count or range, location or department, last calibration date and calibration frequency, from which the system derives the next-due date. A gauge type master sets the default calibration frequency per type. See Gauge, MSA & Calibration.
MSA — Measurement System Analysis — qualifies a measurement system through studies of bias, linearity, stability and Gauge R&R. Gauge R&R (Repeatability & Reproducibility) quantifies variation from the gauge itself (repeatability) and from the operators (reproducibility). A gauge that fails GR&R is flagged before it is used on a control-plan characteristic, and the study is attached as a PPAP element. See the gauge calibration & MSA guide.
Calibration follow-up lists gauges by next-due date and alerts on any approaching or past due, driving the cycle due → sent → calibrated → returned. When a gauge returns, the new calibration date and result are recorded and the next-due date rolls forward. A gauge that fails calibration is quarantined and every characteristic and inspection that used it is flagged for review. See Gauge, MSA & Calibration.
The calibration register (gauge MIS) is the audit-ready list of all gauges with calibration status, history and overdue count — the evidence an IATF 16949 / ISO 9001 auditor asks for under clause 7.1.5 on monitoring and measuring resources. Because it is generated from the same follow-up cycle used daily, the register is always current rather than reconstructed before an audit. See Gauge, MSA & Calibration.
Drawings, control plans, work instructions, FMEAs and PPAP elements are attached to the item or quality record, versioned, and moved through the AC / RJ / AD approval lifecycle — giving controlled-document management under ISO 9001 clause 7.5 without a separate system. A document status dashboard shows completeness per item, so you can see at a glance which controlled documents a part is still missing. See document control.
Change management is a controlled sequence: a change request captures the proposed change, an impact assessment records what it affects, document approval signs off the affected documents, and the change is then executed and reported — with a change dashboard tracking open changes. A CAPA from an 8D, a customer engineering change, or a deviation request all enter here, keeping the FMEA, control plan and specifications current. See Documents & Change Management.
A deviation or concession is a formal, time or quantity bound acceptance of non-conforming product — the AD (Accepted Under Deviation) disposition. It is raised and approved through the deviation-approval workflow, so accepting out-of-spec material is a documented, bounded decision with an owner and an expiry rather than an undocumented pass. The concession is recorded against the lot and visible in the audit trail. See Documents & Change Management.
An approved engineering change or deviation triggers a PPAP re-submission whenever it affects design, process, material, tooling or the supply source — anything the customer's PPAP requirements cover. The change amends the control plan and FMEA and, where required, the quality plan, and the re-PPAP moves the affected elements back through submission and approval. That is how the paperwork stays truthful when the part changes. See the Learn Hub guide to QMS.
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