plm adventures: viewpoints from a customer and a vendor · the ugly customer •the system must...

Institute for Process Excellence #IpXConX18

PLM Adventures: Viewpoints from a Customer and a VendorCatie Jelinski & Susan RockafellowMölnlycke Health Care & Javelin Technologies Inc

IpX Institute for Process Excellence31st Annual

#IpXConX18

DOC ID#: PLM-ADV-CUS-VEN-101Rev Z

Institute for Process Excellence #IpXConX18Institute for Process Excellence #IpXConX18Institute for Process Excellence #IpXConX18

INTRODUCTION TO CATIE• Medical device world for almost 20 years• CM2 Professional, Congress Member,

Toolbox Committee Chair, Advisory Board Member• Current position is Quality and Regulatory

Systems Infrastructure Manager at Mölnlycke, a Swedish medical device company• Business owner of Agile PLM

C-2180C-5 C-1090

The “Customer”

Institute for Process Excellence #IpXConX18Institute for Process Excellence #IpXConX18

2016 CM2 CONFERENCE“NETWORKING”


INTRODUCTION TO SUSAN• PMP®, CM2P Professional, C.E.T.• IpX Partner/Trainer in Canada• Implementing PLM systems since mid

90’s – across diverse industries; such as defence, railway, telecom, manufacturing, medical device, automotive, and ship building …• Professional Services Manager,

PDM/PLM

C-1350C-5 C-1090

The “Vendor”


The Good, The Bad & The UglyPLM Adventures


THE GOOD

Customer• Approved requirements are a

must• Good communication is vital• Good processes make a

difference

Vendor• Customer knows their

requirements, vendors know the tool – need to meet in the middle• Iterative development, you don’t

know what you don’t know• Integrated project team• Training, training, training (CM2,

PLM)


THE GOOD


THE BAD

Customer• Requirements not documented,

or constantly changing• Company culture often dictates

the success or failure of an implementation project

Vendor• Requirements, what requirements?• PLM team? We need a team?• We need to test?


THE BAD


THE UGLY

Customer• The System must probably

comply with the ES requirements within 21 CFR part 11• Internal politics or agendas• Underestimating cultural

changes

Vendor• PLM will fix your bad processes• PLM will fix your bad (legacy)

data• It’s great to have CM2

structured processes, but we also need an uncontrolled change process!


THE UGLY


SUMMARY OF VIEWPOINTSCustomer• Vendors are not evil; manage with

respect and work with them

• Relationships are key (within the

project and with the vendor)

• Good communication is vital

• Approved requirements are a must

• Good processes make a difference

Vendor• Customers Vendors are not evil,

integrate the project team

• Relationships are key – you did pick

us!

• Open lines of communication; be part

of the solution

• Requirement, what requirements?

• Automating bad processes, are still

bad, but they may be bad faster…

• Training, training, training … PLM

software, CM2, foster in-house

expertise


Customer or Vendor We want you to be successful!


QUESTIONS TO YOU

• Who is on their first PLM journey?

• Who is on their second PLM journey?

• Who is on their third – or wants to admit it?

• Who wants to share one “GOOD” thing?

• Who wants to share “BAD” thing?

• Who wants to share one “UGLY” thing?

plm adventures: viewpoints from a customer and a vendor · the ugly customer •the system must...

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