Process audit

A process audit is used in quality management (QM) to assess the quality capability for special products or product groups and their processes . The process audit is part of a company's QM system and should lead to capable and controlled processes that are robust against disturbance variables.

The subject of the audit is the product development process / series production or a service development process / provision of the service.

This is achieved through:

Prevention - Recognizing, identifying and introducing measures to prevent deficits from occurring
Correction - Analyze known deficits and take action to correct and avoid recurrence.
Continuous improvement process - further improve the measures implemented from a process audit in order to make the process more capable and robust.

Occasions

Process audits are carried out according to a specified audit plan, which is part of a company's QM system.

They can be system-oriented or project- oriented .

System-oriented : Only processes that are directly affected are audited and not the entire manufacturing process.
Project-oriented : at specified times in a development and planning process in order to identify deficits promptly.

Unscheduled process audits take place if, for example, product quality drops, customer complaints have been made or changes have been made to the production process.

Audit process

The audit process always follows the same basic scheme:

preparation
execution
Finish with a report
Definition of measures and their pursuit up to the proof of effectiveness.

preparation

Create an audit plan

It is advantageous to draw up an annual plan in which the planned audits for the respective months are listed. This annual plan is made available to the areas or institutions to be audited. The dates listed therein are to be regarded as binding. A postponement of an audit should only be approved in consultation with the management responsible for quality assurance.

A few weeks before the planned implementation, the following steps must be carried out:

Set the audit schedule
Define the audit team
Determine participants
Create a questionnaire

The process to be considered should be divided into individual process steps in order to uncover weak points between the individual interfaces when performing the audit. A catalog of questions is compiled on the basis of process descriptions ( work and test instructions, process instructions or work and test plans ).

Further sources of information for creating the questionnaire can be: Standards , specifications, FMEA , quality control cards , procedural instructions or the catalog of measures from the previous audit. The questionnaire is to be sent to the auditee in good time.

execution

Before the actual audit, an introductory meeting should take place in order to explain the purpose of the audit again and to bring all audit participants to the same level of information. The audit process and the boundary conditions (responsibilities, release of employees during the audit) should also be clarified. In addition, there should be the opportunity to clarify any open questions.

The audit is carried out in an on-site inspection based on the catalog of questions created, whereby the questions do not necessarily have to be asked after numbering. The W questions (why, when, who, how, etc.) are useful for analysis. Further questions can arise during the audit and can be included in the questionnaire.

In the event of serious deficits, immediate measures must be initiated with the person responsible for the process. In order to avoid conflicts at the final meeting, any ambiguities must be clarified on site.

Closing meeting

In the final discussion with a fixed group of participants, all points (negative / positive) are briefly summarized. The auditor shows where there are deficits and potential for improvement. These are summarized in an action plan and activities for the individual points are determined.

evaluation

The evaluation of a process audit can be designed individually. A summary of the deviating points is usually sufficient. In order to be able to compare individual areas with similar processes within an institution, it makes sense to evaluate the individual questions according to a point system. The ratio of the points achieved to the maximum possible number of points then serves as the audit result.
Evaluation scheme of the individual questions according to VDA, Volume 6.3, Edition 2010 (examples):

10 points: Technical specifications for the product and process are complied with.
8 points: Process weaknesses are present, but are recognized and eliminated immediately.
6 points: Process disruptions, products cannot be manufactured reliably.
4 points: Products cannot be manufactured reliably. Process capability not achieved.
0 points: machines, systems unsuitable. Complaints and field failures are to be expected.

The resulting degree of fulfillment represents the audit result. This can be divided into levels A, B or C.

A - 90% - 100%
B - 80% - 89%
C less than 80%

Corrective action and effectiveness check

In principle, the person responsible for the process is responsible for processing the action plan, not the auditor.

The prepared action plan should be processed within an agreed period. It contains all activities with details of those responsible and closing dates in order to eliminate the identified deficits in the process.

The auditor checks the effectiveness of the measures taken on the basis of a sample test, a product audit or also on the basis of machine and process capability studies .

If the effectiveness is not sufficiently proven despite the measures taken, the action plan must be revised or a follow-up audit agreed.

Audit report and documentation

The audit documentation should include all documents that were used in the preparation of the audit, as well as the audit report and action plan.

The report should set out the following:

Process owner / audit participant
short process description
occasion
Audit result
knockout criteria with justification
Deadline for completing the action plan
Questionnaire with evaluation
in the event of deviations, reference to applicable documents (with an example, e.g. as a copy or photo)
Action plan

It should be ensured that only those points are described in the audit report that were also dealt with during the audit and in the final discussion.

Areas of application process audit according to VDA 6.3

P1: Potential Analysis (New)
P2: Project Management (New)
P3: Planning the product and process development
P4: Realization of product and process development
P5: supplier management
P6: process analysis / production
P7: customer care, customer satisfaction, service

literature

VDA Quality Management in the Automotive Industry Volume 6, Part 3 "Process Audit " ISSN 0943-9412

Web links

VDA homepage