Hospital/ HCP/ Site of

event

APPENDIX 1
Medical Device Adverse Event
Complaint Return and Reporting Process

Complaint Handling Form

(myspinetools)

1 day

SHIPPING DELAY
LINED UP IN QUEUE

RA # in SAP

1 day
1

Sales Rep records

complaint

Email / GQF037

GCH/PHO/DHR

Complaint Handling
processes complaint

1 day

Customer Service creates

staging record

4 hours
5 minutes

Receiving at Swinnea
dock

Truck

Unpacking & Recording

Autoclaving

Repacking & shipping

Receiving at Pyramid

Admin records data in

GCH

Testing

Generating report

2 days
1 week

1 day

12 hours

1 day

1 week

1 week

5 min

C/T = 15 minutes

C/T = 90 minutes

C/T = 2 days

C/T = 1 day

C/T = 10 minutes

C/T = 60 minutes

C/T = 20 minutes

C/T = 20 minutes

C/T = 2 hours

C/T = 1 hour

C/T = 2 hours

2 people (rep, cust serv)

4 people max.

1 person

4 - 5 people

1 - 2 people

1 - 2 people

1 person

1 person

1 person

1 person

1 person
* 4 weeks in case of
adverse events only

* Initiator, Communicator, MDR Specialist, Medical

Advisor

1 day

Non-Value
Added
STEP 0

4 hours
15 minutes

Value Added
STEP 1

Non-Value
Added
STEP 1.1

1 day
90 minutes

Value Added
STEP 2

Non-Value
Added
STEP 2.1

3 days
2 days

Value Added
STEP 3

Non-Value
Added
STEP 3.1

1 day

1 week
1 day

Value Added
STEP 4

Non-Value
Added
STEP 4.1

10 minutes

Value Added
STEP 5

Non-Value
Added
STEP 5.1

12 hours
60 minutes

Value Added
STEP 6

Non-Value
Added
STEP 6.1

1 day
20 minutes

Value Added
STEP 7

Non-Value
Added
STEP 7.1

1 week
20 minutes

Value Added
STEP 8

Non-Value
Added
STEP 8.1

1 week
2 hours

Value Added
STEP 9

Non-Value
Added
STEP 9.1

5 minutes
1 hour

Value Added
STEP 10

Non-Value
Added
STEP 10.1

5 minutes
2 hours

Value Added
STEP 11

Non-Value
Added
STEP 11.1

Non-value added time

= 28.65 days
Value added time
= 3.35 days

Total cycle time =

32 days

Process Analysis Worksheet

Time (Hours)
Value
Added

Appendix 2- PAW "AS-IS"

Step #
Step 0
Step 1
Step 1.1
Step 2
Step 2.1
Step 3
Step 3.1
Step 4
Step 4.1
Step 5
Step 5.1
Step 6
Step 6.1
Step 7
Step 7.1
Step 8
Step 8.1
Step 9
Step 9.1
Step 10
Step 10.1
Step 11
Step 11.1

Day of the Complaint

Sales Rep Records Complaint
Email /Phone Call to Company
Complaint Handling Processes
Complaint Recording in GCH
Customer Service Creates Staging Record
Product Shipping
Receiving Product at Swinnea
Product Lined Up in Queue
Unpacking and Recording
Product Lined Up in Queue
Autoclaving
Product Lined Up in Queue
Repacking and Shipping
Product Shipping
Receiving Product at Pyramid
Product Lined Up in Queue
Admin Records Data in GCH
Product Lined Up in Queue
Testing
Compiling Data
Generating Report
Report Approval
Time Totals
Total # of Steps

Time
(Hours)
24
0.3
4
1.5
24
48
72
24
168
0.2
24
1
12
0.3
24
0.3
168
2
168
1
0
2
0.1
768.7
23

Percent Value Added Steps

Percent Value Added Time

48%
10%

Step Description

Target Process Time (Days)

Target Process Time Excluding Weekends (Days)

30
22

"AS-IS" Process Time (Days)

32

Non-Value Added Steps

T

0.0
0

0.0
0

24
0.3
4
1.5
24
48
72
24
168
0.2
24
1
12
0.3
24
0.3
168
2
168
1
2
80.6
11

96.0
2

0.0
0

0.1
24.1
2

568.0
7

Formula (11/23)*100
Formula (80.6/768.7)*100

"2" days higher than 30 days requirement and "10" days higher
excluding weekends

Process Analysis Worksheet

Time (Hours)
Value
Added

Appendix 3- PAW "Improved" Proposal 1

Step #
Step 0
Step 1
Step 1.1
Step 2
Step 2.1
Step 3
Step 3.1
Step 4
Step 4.1
Step 5
Step 5.1
Step 6
Step 6.1
Step 7
Step 7.1
Step 8
Step 8.1
Step 9
Step 9.1
Step 10
Step 10.1
Step 11
Step 11.1

Step Description
Day of the Complaint
Sales Rep Records Complaint
Email /Phone Call to Company
Complaint Handling Processes
Complaint Recording in GCH
Customer Service Creates Staging Record
Product Shipping
Receiving Product at Swinnea
Product Lined Up in Queue
Unpacking and Recording
Product Lined Up in Queue
Autoclaving
Product Lined Up in Queue
Repacking and Shipping
Product Shipping
Receiving Product at Pyramid
Product Lined Up in Queue
Admin Records Data in GCH
Product Lined Up in Queue
Testing
Compiling Data
Generating Report
Report Approval
Time Totals
Total # of Steps
Percent Value Added Steps
Percent Value Added Time

Time
(Hours)
24
0.3
4
1.5
24
48
24
24
126
0.2
24
1
12
0.3
24
0.3
126
2
126
1
0
2
0.1
594.7
23
48%
14%

Target Process Time (Days)

Target Process Time Excluding Weekends (Days)

30
22

"Improved- Proposal 1" Process Time (Days)

25

Process Efficiency Improvement (PEI)

23%

Non-Value Added Steps

T

0.0
0

0.0
0

24
0.3
4
1.5
24
48
24
24
126
0.2
24
1
12
0.3
24
0.3
126
2
126
1
2
80.6
11

48.0
2

0.0
0

0.1
24.1
2

442.0
7

Formula (11/23)*100
Formula (80.6/594.7)*100

"5" days lower than 30 days requirement, but "3" days higher
excluding weekends

Process Analysis Worksheet

Time (Hours)
Value
Added

Appendix 4 - PAW "Improved" Proposal 2

Step #
Step 0
Step 1
Step 1.1
Step 2
Step 2.1
Step 3
Step 3.1
Step 4
Step 6
Step 8.1
Step 9
Step 9.1
Step 10
Step 10.1
Step 11
Step 11.1

Step Description
Day of the Complaint
Sales Rep Records Complaint
Email /Phone Call to Company
Complaint Handling Processes
Complaint Recording in GCH
Customer Service Creates Staging Record
Product Shipping
Receiving Product at Pyramid
Autoclaving
Product Lined Up in Queue
Admin Records Data in GCH
Product Lined Up in Queue
Testing
Compiling Data
Generating Report
Report Approval
Time Totals
Total # of Steps
Percent Value Added Steps
Percent Value Added Time
Target Process Time Including Weekends (Days)
Target Process Time Excluding Weekends (Days)
"Improved- Proposal 2" Process Time (Days)
Process Efficiency Improvement (PEI)

Time
(Hours)
24
0.3
4
1.5
24
48
24
24
1
126
2
126
1
0
2
0.1
407.9
23
35%
20%

Non-Value Added Steps

T

0.0
0

0.0
0

24
0.3
4
1.5
24
48
24
24
1
126
2
126
1
2
79.8
8

24.0
1

0.0
0

0.1
24.1
2

280.0
4

Formula (8/23)*100
Formula (79.8/407.9)*100

30
22
17
47%

"13" days lower than 30 days requirement and "5" days higher
excluding weekends