iso 9001:2015 and change - asq houston...iso 9001:2015 and change h&m definitions that work for...

ISO 9001:2015 and Change

H&M confidential/proprietary document – requires proper H&M release authority for external use

The Controlled PPT is located on the Henkels & McCoy web-site portal

All other copies of this PPT are uncontrolled unless “Controlled Document” stamped in red ink

American Society for Quality

Houston Regional Quality Conference

Friday 13 November 2015

Thomas Anderson, H&M Quality and OQ Director


The impact of ISO 9001:2015 on our TIA activities and CI loop

TIA – Test, QC product Inspection and QA process Audit

CI Loop – Continual Improvement process:

• Actual nonconformity and corrective action

• Potential nonconformity and preventive action

• Opportunity for Improvement (OFI) action


H&M confidential/proprietary document – requires proper H&M release authority for external use

The Controlled PPT is located on the Henkels & McCoy web-site portal

All other copies of this PPT are uncontrolled unless “Controlled Document” stamped in red ink

Henkels & McCoy, Inc. (H&M) - A leading utility construction firm providing critical

infrastructure for the Power, Communications, Oil & Gas Pipeline, and Gas

Distribution markets throughout North America. Founded in 1923 by John B.

Henkels, Jr. Today, H&M is one of the largest privately held firms in the U.S.,

designing, building, and maintaining infrastructure for the energy and

communications markets: Numerous locations and resources strategically

deployed nationwide. H&M consistently ranks in the top ten of Engineering News-

Record's annual list of Specialty Contractors.


Safety & Quality

Contact

Safety Contact

Quality Contact

As Safety is to the Employee, Quality is to the Company

Safety provides PPE and protocols to follow which protect the

employee.

Quality provides competent employees, capable processes,

correct materials and the right equipment, allowing employees to

achieve R3FT.

Performing the Right Work

the Right Way

For the Right Reasons

The First Time

Reasons: Project “On Time, At Cost, Works Right” Performance


“If you give ISO 9001 to a hundred

Quality Engineers, you’d get 100

different QMS approaches.” Why?

Answer: The ISO 9001 require-

ments are not prescriptive

Test – Determination (validation) according to requirements

for a specific intended use or application

Inspection – Determination (verification) of conformity to

specified requirements

Audit – Systematic, independent and documented process for

obtaining objective evidence and evaluating it objectively to

determine the extent to which the audit criteria are fulfilled


H&M Definitions that work for Us:

Test – Any QC Inspection using measurement

equipment to confirm quality acceptance

(functionality) to specification

Inspection – Reactive QC check of the constructed

deliverable (or some portion) to verify

conformity to the acceptance criteria

Audit – Proactive QA process obtaining objective

evidence that people, process, materials and

equipment are fulfilling the audit criteria.

TIA Activities

Contract, Drawings, Specs, Regulations, Standards…


H&M Expects TIA activities to:

Confirm Conformity

These TIA reports with objective evidence of conformity go

into the quality records. The information and data is tracked,

trended, analyzed and reported in:

• A Quality Record Tracking Log Data Base

• Weekly Project and Division Dashboards

• Monthly PSR (Project Status Report) Presentations

• Lessons Learned Summaries and Annual Assessments


H&M anticipates TIA activities may:

Identify Nonconformity

TIA reports with objective evidence of nonconformity go into

the quality records, etc. Nonconformity requires:

• Actual nonconformity requires Corrective Action

- Completion of a CAR (Corrective Action Report)

- This may require a NCR (Nonconformity Report)

• Potential nonconformity requires Preventive Action

- Completion of a PAR (Preventive Action Report)


H&M expects TIA activities to:

Identify OFIs (Opportunities For Improvement)

TIA reports with OFIs go into the quality records, etc. OFIs

encourage improvements in:

• People – Task Competency

• Process - Capable

• Materials – Constructability and Ease of Use

• Equipment – Right Tools, Well Maintained

Any impact on “On Time, At Cost, Works Right” performance


Excellent firms (organizations) don’t believe in excellence, only in

constant improvement and constant change

– Tom Peters

Continual Improvement – Recurring activity to enhance

performance

The H&M Continual Improvement Loop:

• To improve project “on time, at cost, works right”

performance and overall H&M performance

• To enhance customer satisfaction

• To improve the QMS approach

• To lead towards H&M operational excellence (OPEX)


• Safety

• Reputation

• Gross Margin

• Revenue

• Favorable Contract (Reduced Risk)

• Operating Cost

• Increased Profits


ASQ/ANSI/ISO 9001:2015

Improvement (General)

• To determine and select

opportunities for improvement

• To meet customer requirements

• To enhance customer satisfaction

When actual nonconformity occurs, take CA to: React, evaluate,

implement, review, update and make changes

[see risk-based thinking for preventive controls]

Continually improve the suitability, adequacy and effectiveness of

the QMS.


ASQ/ANSI/ISO 9001:2015

“Prevent” in various forms is mentioned 14 times. Intent:

• To determine factors causing deviation from the plan

• Avoid undesirable results and/or unintended use or delivery

• Reduce / Eliminate:

- Potential Nonconformance

- Negative Effects, undesired effects, adverse impacts

• “Burnout prevention”

• Prevent human error


Quality Acceptance

Test

Quality Control

Inspection

Quality Assurance

Audit

Any Other

Legitimate Input

Confirm Conformity

Corrective Action

Preventive Action

Opportunity for

Improvement

Confirm Conformity

Continual Improvement Loop

Archive In Quality

Record

Continual Cycle of

TIA Activities or

Other Input


Quality Acceptance

Test

Quality Control

Inspection

Quality Assurance

Audit

Any Other

Legitimate Input

Corrective Action

Preventive Action

Opportunity for

Improvement


For Actual Nonconformity

Archive In Quality

Record

Continual Cycle of

TIA Activities or

Other Input

Identify Actual

NonconformityConfirm Conformity


Quality Acceptance

Test

Quality Control

Inspection

Quality Assurance

Audit

Any Other

Legitimate Input

Corrective Action

Preventive Action

Opportunity for

Improvement


For Potential Nonconformity

Archive In Quality

Record

Continual Cycle of

TIA Activities or

Other Input

Identify Potential

NonconformityConfirm Conformity


Quality Acceptance

Test

Quality Control

Inspection

Quality Assurance

Audit

Any Other

Legitimate Input

Corrective Action

Preventive Action

Opportunity for

Improvement


For OFI (Opportunity For Improvement)

Archive In Quality

Record

Continual Cycle of

TIA Activities or

Other Input

Identify OFI Confirm Conformity


Risk-Based Thinking – Requires an Enterprise to identify risks

and opportunities, and controls/actions needed to assure a

suitable, adequate and effective QMS.

No requirement to implement a specific, formal risk

management system, but... What are you going to do?

Must have:

• Risk Management Methodology

• Risk Response Plan

Be Aware:

• Not everything can be crystal-balled

• An “in the moment” preventive action process to deal

with potential nonconformity is essential.


Questions and Answers

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