PROCESS APPROACH

1. A Process has:• An objective (What are we trying to do?)• Measure of effectiveness (How are we doing at it?)• An Owner (Who has overall responsibility?)• Requires Management (Improvement & action when

not meeting the objective)• Requires Resources and Info (Who and how?)• Transforms Inputs into Outputs • Linked to other processes in the chain

TYPES OF QMS PROCESSES• COPS – Core Processes (Very important to our

business)

• SOPS – Support Oriented Processes (2 types) Global Support Processes – the processes that are

done inside of many or most other Core Processes – such as Document Control/ Records/ Training/ Corrective Action/ Cont. Improvement/ Preventive Action/ Calibration/ etc…

Management Oriented Processes – the processes by which upper management monitors the system (checks and balances) – such as Management Review and Internal Audits.

WHY THE PROCESS BASED APPROACH?

• Adds more value to the audit process• Allows us to determine if we are meeting the

objectives of our Critical Processes (COPS) • Feeds process measures into Mgmnt Review

(measuring processes of the QMS) for action when needed

• Allows for QMS Improvement through use of metrics/ measures of the COPS

IMPACT ON OUR AUDITS

• Requires that the auditors know the Global Support Process/ procedures that will be audited within each COP audit

• Is not just a “checklist based” audit – relies more on the auditors to understand the processes more

• The audit schedule will be broken down into COPS and Mgmnt. Process audits vs TS 16949/ AS 9100 clauses

• We will audit the effectiveness of the process activities vs just assuring compliance to a procedure

AUDITOR TOOLBOX

• SIPOC Diagram for the process being audited• Internal Audit records from previous audits• Internal Audit Worksheet (Checklists, notes/

questions developed by Auditors during preparation)• QSR QMS flow diagram/ map• Required procedures/ instructions/ etc..

TYPICAL AUDIT STEPSBEFORE THE AUDIT• Review/ understand the process being audited and

objectives• Review specific and Global procedures/ work

instructions and forms used• Finalize audit date/ time with auditees

TYPICAL AUDIT STEPSDURING THE AUDIT• Opening Meeting (brief)• Review objectives/ metrics for process with owner• Review need for corrective action if not meeting goal• Review continual Improvement being made in the

process• Audit to the objectives, procedures and work

instructions as applicable• Answer process audit worksheets/ checklists• Record audit results on Audit Records/ Forms/

procedures

TYPICAL AUDIT STEPSDURING THE AUDIT• Review Findings or concerns with the auditees• Finalize the audit records (Checklists, records, etc…)• Submit results to Process Owner and Quality

Systems Engineer.

TYPICAL AUDIT STEPSAFTER THE AUDIT• Corrective Actions needed are issued by Quality

Systems Engineer to champion.• Corrective Actions are verified for completeness and

effectiveness upon completion• If needed a follow-up audit is scheduled

Process

Process Owner:

Supplier(s)

Input(s)

Customer(s)

Output(s)

Methods:

Resources: Metrics:

BLANK SIPOC DIAGRAM