asq meeting 9-25-2019 surviving the 3 party audit

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


3 Requirements of ISO, AS, etc.

•On-time Delivery

•High Quality Product

•Meets Customer Requirements


3rd Party Audits – What the Auditor looks for:

•Evidence, Evidence and

•More Evidence


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


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


If you can’t Prove It

It Didn’t Happen


No Evidence

Means a Finding


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


Section 5 Leadership

• Evidence of Leadership

• Risk Based Thinking

• Customer Focus – Satisfaction

• A good Quality Policy that’s communicated

• Are adequate resources provided


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


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



• 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



• What is Documented Information??

– Prints, Specs, contracts, QMS

• Control creation/changes

• Retrieval – easily

• Correction Fluid/Tape = Finding/ Integrity

• Disposition – customer information


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


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


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


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


8.6 Release of Product

• Who, How, Documents

• ATP’s, Sample Testing, Destructive Testing

• Lab – Equipment Calibration, Training

• Outside Lab Documents


8.7 Non-conforming Outputs

• Segregate, Segregate, Indicate

• Scrap, Rework, Customer Concessions

• Re-test, if plan to release


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


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


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”


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


10.3 Continual Improvement

• Continually Improve:

– Suitability

– Adequacy

– Effectiveness

• Sources: CARs, All Audits, Inspection Results, Vendors, Customers, RMA’s, Complaints, suggestions



Contact us at:


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
