asq meeting 9-25-2019 surviving the 3 party audit
TRANSCRIPT
Enterprise Solutions, Inc.
ASQ Meeting 9-25-2019
Surviving the 3rd Party Audit
Presented by:
Jim BenzEnterprise Solutions, Inc.
*
3rd Party Audits
•Some can Help you
•Some can Hurt you
•Some can Kill you
Enterprise Solutions, Inc.
3 Requirements of ISO, AS, etc.
•On-time Delivery
•High Quality Product
•Meets Customer Requirements
Enterprise Solutions, Inc.
3rd Party Audits – What the Auditor looks for:
•Evidence, Evidence and
•More Evidence
Enterprise Solutions, Inc.
3rd Party Audits
• Be Prepared
• Know what the auditor needs
• Respond Quickly
• Be cooperative
• Provide a reasonable working area
• Plan to have lunch brought in
Enterprise Solutions, Inc.
3rd Party Audits – What the Auditor looks for:
• Process Flow Diagram
• Processes – Inputs, Outputs, Metrics, Targets, Actual Performance, Corrective Actions
• Process Turtles are good
• Regular Reviews & Actions Taken
Enterprise Solutions, Inc.
If you can’t Prove It
It Didn’t Happen
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No Evidence
Means a Finding
Enterprise Solutions, Inc.
Section 4 Context
• What does the business do
• How do you monitor and review it
• Do you look at internal and external issues
• Do you look at Postitives and Negatives
• Interested Parties
• Scope, justify exclusions
• Processes defined
Enterprise Solutions, Inc.
Section 5 Leadership
• Evidence of Leadership
• Risk Based Thinking
• Customer Focus – Satisfaction
• A good Quality Policy that’s communicated
• Are adequate resources provided
Enterprise Solutions, Inc.
Section 6 - Planning
• Risk / Opportunities Register – some quantification & Prioritization
• Address Options & Alternatives
• Overall Quality Objectives – Minimum
– On-time Delivery
– Highest Quality
– Meet customer requirements
• Control Changes – All Changes
Enterprise Solutions, Inc.
Section 7 - Resources
• Appropriate personnel
• Infrastructure – buildings/equipment, shipping/receiving, IT/Communications
• Environment – all human factors
• Monitoring & Measuring – how, evidence
• Organizational Knowledge – information, training, backups
Enterprise Solutions, Inc.
Section 7 - Resources
• Competence
• Training Plans AND Records
• Awareness of their contributions, risks, failure impacts
• Are there adequate communications
• Is the QMS Documented – is it current, are changes tracked / documented
Enterprise Solutions, Inc.
Section 7 - Resources
• What is Documented Information??
– Prints, Specs, contracts, QMS
• Control creation/changes
• Retrieval – easily
• Correction Fluid/Tape = Finding/ Integrity
• Disposition – customer information
Enterprise Solutions, Inc.
Section 8.1 - Planning
• 8.1 – Requirements for Product / Service
– Processes used
– Acceptance criteria – ATP’s, FMEA’s, etc.
– Resources needed for On-Time Delivery
• Product Release Process / Documentation
Enterprise Solutions, Inc.
Section 8.2 – Product Requirements
• Customer Communication – Changes, Complaints, customer property
• Statutory / Regulatory requirements
• Un-Stated – clean, safe, guards, packaging
• Meets claims of performance
• Contract Review – Post-Delivery, Changes
after Quote Accepted
• Change ProcessEnterprise Solutions, Inc.
8.3 Design & Development
• What is your Process – Gated / Documented
• Prove that you follow it - Approvals
• Plans, Inputs, Controls / Reviews, Outputs, Changes
Enterprise Solutions, Inc.
8.4 - Purchasing
• Approved Vendor Process
• Periodic Reviews and Tracking
• Applicable information – Prints, Specs
• Competence, Cert’s, CofC’s, CofA’s
• PO Specs – detailed
• Off-site testing / certification
• Verification, Validation - airplane
Enterprise Solutions, Inc.
8.5 Production & Service
• Controlled Conditions / Data / Testing
• Special Processes – periodic validation
• ID & Traceability – how, docs, Stamp Control,
s/n’s, Barcodes
• Customer Property
• Product Preservation – Transportation
• Post-Delivery
• Change Control and Phase-in
Enterprise Solutions, Inc.
8.6 Release of Product
• Who, How, Documents
• ATP’s, Sample Testing, Destructive Testing
• Lab – Equipment Calibration, Training
• Outside Lab Documents
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8.7 Non-conforming Outputs
• Segregate, Segregate, Indicate
• Scrap, Rework, Customer Concessions
• Re-test, if plan to release
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9.1 Monitoring, Measuring, Analysis & Evaluation• What, How, Who does this
• Must be documented
• Maintain and retrieve docs & data
• Customer Satisfaction – Documented,
surveys, call-sheets, return business, RMA’s, complaints
• Analysis of data – Performance of QMS, Risk
Data, Supplier Performance, SPC, etc
Enterprise Solutions, Inc.
9.2 Internal Audits
• Scheduled
• Trained Auditors – one Lead Auditor
• Standard Format – Processes & Clauses
• Complete report – with EVIDENCE!!!
• Need Findings and CARs
• Follow-up to assure corrected
Enterprise Solutions, Inc.
9.3 Management Review
• Very Important – the heart of the QMS
• Follow 9.3 Inputs & Outputs – All
• Address Risks, Resources & Improvements
• Should have: Statistics, Charts, Graphs,
Analysis, Findings, Recommendations, Review of Prior “To Do’s”
Enterprise Solutions, Inc.
10.2 NCR’s and CAR’s
• All NC’s, including Complaints – document
for trends
• Correction, Root Cause, Corrective Action – then monitor, monitor, monitor
• Similar situations that need attention
• Human Factors – strong root cause area
• Document! – flow-down to other areas
Enterprise Solutions, Inc.
10.3 Continual Improvement
• Continually Improve:
– Suitability
– Adequacy
– Effectiveness
• Sources: CARs, All Audits, Inspection Results, Vendors, Customers, RMA’s, Complaints, suggestions
Enterprise Solutions, Inc.
Enterprise Solutions, Inc.
Contact us at:
Enterprise Solutions, Inc.
Carol Wright & Jim Benz
Suite 300
706 East Avenue
Rochester, NY 14607
585 241 2090 (fax 585 241 2099)
www.esiresults.com
Good Luck!
Q & A
Enterprise Solutions, Inc.