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Templates and records · IATF 16949 · Clause 9.1.1.1

Process capability study and SPC in IATF 16949

Showing that a process makes parts within tolerance is not enough: you have to show that it does so stably and with margin, and react as soon as it stops.

In one sentence

The capability study and statistical process control show that a characteristic is produced stably and with margin against the tolerance, and detect when that stops being true, because IATF 16949 requires studies on all new processes, maintenance of the capability set by customer approval, reaction plans when the process is not capable or stable, and the recording of significant process events (9.1.1.1).

Content reviewed on

Where the standard requires it
IATF 16949 · Clause 9.1.1.1 Clauses are those of IATF 16949:2016, which always applies together with ISO 9001:2015. The AIAG and VDA manuals cited are industry references that apply when the customer requires them; they are not part of the standard.
Type of information
Mandatory record Process results and events to be retained (9.1.1.1)
Who fills it in
Quality engineering Operators record the data; quality analyses it and decides on the reaction
When
At launch and on an ongoing basis Initial study before PPAP; monitoring at the frequency in the control plan
How long it is kept
Organisation’s policy IATF requires a documented record retention policy that meets statutory, regulatory, organisational and customer requirements (7.5.3.2.1).

What the standard requires


What IATF 16949 demands and what it leaves to your judgement

The standard requires process studies on all new manufacturing processes —including assembly and sequencing— to verify process capability and provide input for process control, and the capability or performance required by the customer’s part approval process to be maintained.

It also requires checks that the control plan is applied with its measurement techniques, sampling plans and acceptance criteria, actual variable values to be recorded, the reaction plan to be initiated when a characteristic is not stable or capable —with containment and 100% inspection where appropriate— and significant events such as tool changes or repairs to be recorded.

The thresholds are set by the customer. The AIAG PPAP manual uses a performance index of 1.67 for initial studies and a capability index of 1.33 for stable series processes as its reference.

Structure


Fields the template should include

  • Characteristic, specification and special classification
  • Measuring equipment and its MSA result
  • Subgroup size and sampling frequency
  • Control chart with calculated limits
  • Stability: out-of-control points and patterns
  • Capability or performance indices (Cpk, Ppk) and the customer’s criterion
  • Process events: tool changes, repairs, material changes
  • Reaction plan applied and containment
  • Action plan if the characteristic is not capable

Example


Example: monitoring push-out torque in series production

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field Content
Characteristic Nut push-out torque ≥ 40 N·m · special characteristic
Sampling Subgroups of 5 parts per shift · X-bar and R chart
Initial study Ppk 1.92 in the March 2026 PPAP
April Cpk 1.58 · stable process
Event recorded 12 May, change of electrode supplier
May Seven consecutive points below the mean · Cpk 1.21
Reaction 100% torque inspection from 14 May and engineering alerted
Cause and action New electrode with lower conductivity · current adjusted and validated
Result June: Cpk 1.63 · 100% inspection withdrawn

At the audit


Mistakes auditors commonly flag

  • Control charts filled in without anyone reacting to out-of-control points.
  • Capability indices calculated on unstable processes.
  • Data recorded at the end of the shift, all identical, that do not reflect the process.
  • Tool changes and repairs are not recorded, so shifts in the data cannot be explained.
  • Special characteristics with no statistical monitoring even though the customer requires it.

In Kimobox


How this record is kept in Kimobox

  1. 1SPC is calculated automatically from the data the shop floor already records, with no export to a separate spreadsheet.
  2. 2Process capability for critical characteristics is monitored continuously.
  3. 3A result outside the criterion opens a nonconformity with its containment and root cause.
  4. 4Plant indicators reach the management review already aggregated.

Frequently asked questions


What people ask us before getting started

What is the difference between Cpk and Ppk?

Both compare the tolerance with the process spread. Cpk uses within-subgroup variation and is meaningful for a stable process; Ppk uses total variation and is used in initial studies, before stability has been demonstrated.

What Cpk value is required?

Whatever the customer sets. As a reference, the AIAG PPAP manual considers a Ppk of 1.67 acceptable in the initial study and a Cpk of 1.33 in stable processes; some safety characteristics have higher thresholds.

Does every characteristic need SPC?

No. It applies to the characteristics that require it according to the FMEA, the control plan and the customer’s requirements, especially special characteristics. The rest are controlled with the method the plan defines.

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Sources


Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

  1. IATF 16949:2016 — Quality management system requirements for automotive production and relevant service parts organizations IATF · First edition, October 2016
  2. Statistical Process Control (SPC) (industry reference, not part of the standard) AIAG · 2nd edition, 2005
  3. Production Part Approval Process (PPAP) (industry reference, not part of the standard) AIAG · 4th edition, 2006