CUST327

Using PTC Windchill to

Prepare for ISO Audits

Prakash Vishwanathan
Industrial Engineer, Hagler Systems

Hemant Jatla
Principal, Datafrond LLC
Siva Jatla
Solutions Manager, Datafrond LLC

Boston, MA
June 18, 2014 * All presentations are subject to change

Agenda

Table of Contents
• Introductions

• Scope
– Quality Documentation and Records Control
– Employee Training Records Management
– Equipment Calibration – Predictive Maintenance

• Business Need

• Solution

• Live Demonstration

• Q&A

2
Introductions

Presenters
• Prakash Viswanathan – Industrial Engineer, Hagler Systems
– Prakash is an Industrial Engineer at Hagler Systems. He holds a M.S. in Industrial Engineering
from the Georgia Institute of Technology where he focused on simulation, design analysis and
productivity measurement/analysis. He specializes in production and logistics planning, supply
chain management, Six Sigma and Lean Manufacturing. He has lead Hagler Systems, an
industrial manufacturing company, in the implementation and use of Microsoft Dynamics
AX(ERP) and PTC Windchill (PLM).

• Hemant Jatla – Principal, Datafrond LLC

– Hemant is a principal at Datafrond. He has over 16 years of experience in recommending
solutions to complex product development issues, and then designs and implements business
processes and systems using PLM technologies. Many of his large scale PLM implementations
have been for Fortune 500 clients. He has successfully managed large and complex client
engagements through planning, consulting, and implementation, and delivery of PLM systems.
He holds a B.S. in Mechanical Engineering and a MBA from Xavier University.

Scope

ISO 9001 / 13485 Process Requirements

• Management • Equipment
– Management Reviews – Calibration Records
– Internal Audits – Preventive Maintenance
– External Audits
• Quality Control
• Personnel & Safety – Corrective & Preventive Action
– Job Training Records – Control Plans
– Safety Meetings – Nonconformance
– Environmental Safety Records – Return Goods

4
Business Need

Opportunity
• Maximize existing PTC Windchill investment and infrastructure to support
ISO Audit Requirements.

• Link Product Data to Quality Records thus reducing the manual labor when
generating audit reports.

• Improve user adoption by minimizing IT systems footprint.

• Reduce overall turnaround and preparation time required to submit and

pass an ISO Audit.

Business Need

Solution Requirements – Quality Document and Records Control

• Document Control
– Version Control Documents with auto-generated PDF document headers that contain metadata ,
company logo and statement that “PRINTED COPIES are UNCONTROLLED”.
– Quality Documents include (not limited to): Quality Manuals, Quality Procedures, Quality Forms
and Standard Operating Procedures / Work Instructions, etc.
– Quality Records (not limited to): MSDS, Internal / External Audits, Safety Meetings,
Environmental Certs, Supplier Audits, Third Party Audits, etc.

• Workflows
– Department Approvals
– Management Approvals
– Management Reviews

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Business Need

Solution Requirements – Employee Training Records Management

• Records Management
– Create and maintain Employees and Job Descriptions.
– Link Version Controlled Standard Operating Procedures/Work Instructions to Job Descriptions.
– Maintain training record history for employees, contractors and temporary hires.

• Reports
– Required Job Training by Employee, Job Description and the specific version of Quality Manual.
– Completed Job Training by Employee and Job Description and the specific version of Quality
Manual.

Business Need

Solution Requirements – Calibration Records and Preventive Maintenance

• Records Management
– Each Asset is uniquely maintained within the system, each asset is recorded by asset type and
maintains a status of “In Service” or “Out of Service”.
– Asset will be categorized by the Asset Types and contain attributes to record manufacturer,
serial number, etc.
– Track spare parts and record the required number of spares.
– Record Scheduled Maintenance and break fix requests.

• Workflows
– Preventative (Scheduled) Maintenance – 7 / 14 / 30 / 60 / 90 / 180 / 365 / 730 days
– Break fix Request

• Reports
– Display upcoming Scheduled Maintenance Tasks for a given range of days.
– Display the list of Open Break fix requests for a given range of days.
– Display the list of Closed Break fix requests for a given range of days.

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The Solution

Live Demo – Quality Document Control

The Solution

Live Demo – Calibration Records and Preventive Maintenance

10
The Solution

Live Demo – Employee Training Records Management

11

Q&A

liveglobal.ptc.com