Change Control Signature Responsibilities

1.

What is the definition of Owning Department?

A.

The department of the Originator of the DCR
B.

The primary user of the document
C.

The owning department is always Quality
D.

The department of the person who wrote the document

Correct Answer
B. The primary user of the document

2.

To help ensure that collaborations are effective, Collaboration tasks should be assigned to all approvers of a DCR. Who would you assign as collaborators for a DCR that contained the Document Type: Fabrication BOM used in the Elegant Elite family. Select all that apply.

A.

Process Quality Engineer (D. Callahan)
B.

Surgical Device Engineering Team (G. Aldrich)
C.

Process Quality Engineer (P. Langworthy)
D.

Production Engineering (T. Beer)
E.

Materials (S. Faulkner)
F.

Cost Accounting (B. McKenty)
G.

ERP System (G. Metz)
H.

Production Engineer (P. Wethey)
I.

Fabrication (W. Halfman)

Correct Answer(s)
A. Process Quality Engineer (D. Callahan)
B. Surgical Device Engineering Team (G. Aldrich)
D. Production Engineering (T. Beer)
E. Materials (S. Faulkner)
F. Cost Accounting (B. McKenty)
G. ERP System (G. Metz)
I. Fabrication (W. Halfman)

3.

To help ensure that collaborations are effective, Collaboration tasks should be assigned to all approvers of a DCR. Who would you assign as collaborators for a DCR that contained the Document Type: Work Instructions-Assembly used in the Cleaning Lab. Select all that apply.

A.

Training (M. Melendez)
B.

Clean Lab (C. Owens)
C.

Process Quality Engineer (D. Callahan)
D.

Production (D. Kinsella)

Correct Answer(s)
A. Training (M. Melendez)
B. Clean Lab (C. Owens)
C. Process Quality Engineer (D. Callahan)

4.

To help ensure that collaborations are effective, Collaboration tasks should be assigned to all approvers of a DCR. Who would you assign as collaborators for a DCR that contained the Document Type: Design Report used in the Sewing family. Select all that apply.

A.

Independent Reviewer (Found on Project Charter)
B.

Development Group (J. Guelzow)
C.

Discovery (A. Martellaro)
D.

Intellectual Property (C. Miller)
E.

Operations (J. Nicosia)
F.

Design Quality Engineering (D, Derleth)
G.

Product Development (Z. Tyo)
H.

Quality Engineering (D. Fenton)
I.

Regulatory Affairs
J.

Engineering (R. Zitzka)

Correct Answer(s)
A. Independent Reviewer (Found on Project Charter)
B. Development Group (J. Guelzow)
C. Discovery (A. Martellaro)
D. Intellectual Property (C. Miller)
E. Operations (J. Nicosia)
G. Product Development (Z. Tyo)
H. Quality Engineering (D. Fenton)
I. Regulatory Affairs

5.

To help ensure that collaborations are effective, Collaboration tasks should be assigned to all approvers of a DCR. Who would you assign as collaborators for a DCR that contained the Document Type: Artwork-Labels, Drawing-General and BOM used in Molding for Sewing family. Select all that apply.

A.

Growth Group (B. Bartz)
B.

Development Group (J. Guelzow)
C.

Art (A. Ryan)
D.

Regulatory Affairs
E.

Marketing (B. Keller)
F.

Materials (S. Faulkner)
G.

Surgical Device Engineering Team (S. Scheuermann)
H.

Surgical Device Engineering Team (G. Aldrich
I.

Fabrication (W. Halfman)
J.

Cost Accounting (B. McKenty)
K.

Production Engineering (V. Sauer)
L.

Molding (E. Sutorious)
M.

Measurement Systems (J. Murray)
N.

Intellectual Property (C. Miller)
O.

ERP System (G. Metz)
P.

Process Quality Engineer (P. Langworthy)

Correct Answer(s)
A. Growth Group (B. Bartz)
B. Development Group (J. Guelzow)
C. Art (A. Ryan)
D. Regulatory Affairs
E. Marketing (B. Keller)
F. Materials (S. Faulkner)
G. Surgical Device Engineering Team (S. Scheuermann)
J. Cost Accounting (B. McKenty)
K. Production Engineering (V. Sauer)
L. Molding (E. Sutorious)
M. Measurement Systems (J. Murray)
N. Intellectual Property (C. Miller)
O. ERP System (G. Metz)
P. Process Quality Engineer (P. Langworthy)

6.

To help ensure that collaborations are effective, Collaboration tasks should be assigned to all approvers of a DCR. Who would you assign as collaborators for a DCR that contained the Document Type: Work Instructions-Assembly used in the Cleanroom in the Knot Tying family and BOM used in Cleanroom. Select all that apply.

A.

Owning Department (Production, D. Kinsella)
B.

Training Management (M. Melendez)
C.

Surgical Device Engineering Team (S. Scheuermann)
D.

Surgical Device Engineering Team (O. Naumovski)
E.

Production Engineering (B. Barnes)
F.

Materials (S. Faulkner)
G.

Cost Accounting (B. McKenty)
H.

ERP System (G. Metz)
I.

Process Quality Engineer (A. Brown)
J.

Owning Department (Cleanroom, L. Rideout)

Correct Answer(s)
B. Training Management (M. Melendez)
D. Surgical Device Engineering Team (O. Naumovski)
E. Production Engineering (B. Barnes)
F. Materials (S. Faulkner)
G. Cost Accounting (B. McKenty)
H. ERP System (G. Metz)
I. Process Quality Engineer (A. Brown)
J. Owning Department (Cleanroom, L. Rideout)