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0 LAYERED
PROCESS AUDITS
Were Leadership Layered
Process Audits
Performed?
Quality Systems Basics rev March 2009
Global Purchasing and Supply Chain
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
223
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
224
SCOPE:
Assembly Area
Manufacturing Operations
Shipping / Receiving
All Operations
Other Support Functions
RESPONSIBILITY:
Ownership
Plant / Operations Mgr
Contingency Plan for All
Situations
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
225
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
226
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
227
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
228
Choose the
Workstation
Follow-up
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
229
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
230
Executive
Executive
Managers
Managers
/ Directors
Directors
Quarterly
Quarterly/ /
minimum
minimum
(Example)
Plant
PlantManager
Manager
11time
time/ month
/ month
Manager
/ Engineers
Manager
/ Engineers
time/week
1 1time/week
Supervisor
/ Team
LeaderLeader
Supervisor
/ Team
DailyDaily
/ Weekly
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
231
(Example)
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
232
(Example)
(continued)
Identifying Audits to be
completed by the
leadership staff is
essential to ensure that
all areas on the shop
floor interact with the
management team. An
example schedule at
the right addresses both
the required frequency
by manager and the
status of this
interaction.
Shaded in
as Audit is
Completed
Shaded in
Red if Not
Completed
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
233
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
234
(continued)
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
235
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
236
(continued)
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
237
The intent is to have a single page LPA Check sheet form that is
manually completed on production floor. The back side of
the
form is available to write down the noncompliance comments.
Establish LPA Check sheet questions from the high risk items.
A LPA Check sheet should have two common sections (Work Station
and Manufacturing System) and one section (Quality Focused), that
is customized to a specific Product Line or Area of the Plant.
Work Station and Quality Focused sections of the LPA Check sheet
shall be completed by all auditors. The Manufacturing System
section shall be completed by the site leadership only.
A LPA Check sheet should be created for each unique processing
area
Quality Systems Basics rev March 2009
Global Purchasing and Supply Chain
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
238
(Example)
In this Example
the
Manufacturer
would have (4)
four unique one
page audit
forms/files, to
cover all
processes.
Section #1:
COMMON Work Station Questions
Section #2:
UNIQUE Quality Focused
Questions
Section #3:
COMMON Manufacturing System
Questions
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
239
(Example)
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
240
(Example)
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
241
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
242
(Example)
Y
NC
N = Deviation Found
Y = Meets Standard
If the item is Corrected
Immediately
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
243
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
244
(Example)
Item # Date Location
4 7/7/08
6 7/7/08
Problem Description
Owner
Target
Complete
date Initials Date
Countermeasure
7/28/08
JC
8/3/08
RS
7/26/08
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
245
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
246
47
43
90%
43
45
80%
40
70%
35
60%
30
27
24
23
50%
40%
16
30%
25
22
20
19
20
16
14
15
20%
10
10%
5
0
0%
JAN
FEB
MAR
% IN COMPLIANCE:
# OF ITEMS ON ASSESSMENT:
# OF ASSESSMENTS
TOTAL # OF ITEMS ASSESSED:
# OF ITEMS IN COMPLIANCE:
NON CONFORMANCES
NON CONFORMANCES
Safety
Missed Audits
5S Related
Product
Voice of Customer
Systemic
Gage Calibration
Poke Yoke
APR
MAY
JAN
88%
20
20
400
353
47
10
10
2
10
6
9
JUNE
FEB
68%
15
9
135
92
43
8
8
7
4
4
7
5
JUL
MAR
95%
20
28
560
533
27
5
3
7
3
2
1
6
AUG
APR
96%
30
15
450
434
16
2
2
3
2
2
2
3
SEP
MAY
97%
20
20
400
386
14
OCT
JUNE
84%
10
10
100
84
16
NOV
JUL
95%
20
20
400
380
20
DEC
AUG
95%
25
20
500
477
23
SEP
94%
20
20
400
376
24
OCT
95%
20
20
400
381
19
1
1
2
1
2
2
2
8
NOV
95%
20
20
400
378
22
1
1
3
1
2
2
2
10
DEC
89%
20
20
400
357
43
1
10
2
10
10
2
2
6
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
247
FR
PS
NCP
VS
WPO
SWI (SOS)
OI(JES)
MGC
SOT
EPV
LPA
Risk
Contam
SCM
MC
WS
248