Global Risk Management Alliance: Survey Results

Application of Risk Management Survey Results

			1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	Total	% Total
		Biologic	0	0	0	0	0		0	0	0	0	0	0	0	0	0		0	0	0	0	0		0
		Drug	0	0	0	0	0		0	0	0	0	0	0	0	0	0		0	0	0	0	0		0
		Device	1	1	1	1	1		1	0	1	1	1	1	1	1	1		1	1	1	1	1		18
		IVD	0	0	0	0	0		0	1	0	0	0	1	0	1	0		0	0	0	0	0		3
RISK MANAGEMENT PROCESS

1	Has your company established a formal risk policy	Yes	0	0	1	1	0	0	1	0	1	0	0	0	0	0	1	0	1	0	1	1	1	1	10	45.45
		No	1	1	0	0	1	1	0	1	0	1	1	1	1	1	0	1	0	1	0	0	0	0	12	54.55
		Rating	5	3	0	0	2	2	5	2	7	3	2	4	3	4	4	5	7	4	0	0	0	5	3.941176471
2	Has your company established procedures for risk management	Yes	0	0	0	0	1	1	1	0	1	0	0	0	0	0	0	0	1	0	0	1	1	0	7	31.82
		No	1	1	1	1	0	0	0	1	0	1	1	1	1	1	1	1	0	1	1	0	0	1	15	68.18
		Rating	2	4		3	2	0	5	2	6	3	2	4	3	4	4	4	7	3	5	0	0	2	3.611111111
3	Do you have an established list(s) of hazards for your product(s)?	Yes	1	1	1	0	0	1	1	1	0	1	1	1	1	1	1	1	1	1	1	1	1	0	18	81.82
		No	0	0	0	1	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	4	18.18
		Rating	0	0	0	3	0	0	5	4	4	0	0	7	6	7	5	7	7	0	0	0	0	4	5.363636364

RISK ASSESSMENT AND CONTROL TECHNIQUES

4	Your company uses the following tools to assess and control product and process risks:
																									Total	% Total
	Fault Tree Analysis (FTA)	Yes	0	1	1	0	1	1	1	1	1	0	0	0	0	0	0	1	1	1	1	1	1	0	13	59.09
		No	1	0	0	1	0	0	0	0	0	1	1	0	1	0	1	0	0	0	0	0	0	1	7	31.82
		Rating	4	0	0	3	0	0	7	4	7	4	4	4	3	4	3	7	7	0	0	0	0	2	4.5
	Failure Mode and Effect and/or Criticality Analysis (FMEA &/or FMECA) for product design	Yes	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	0	1	1	1	21	95.45
		No	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	4.55
		Rating	0	0	0	0	0	0	7	4	7	0	0	6	4	6	4	7	7	0	3	0	0	5	5.454545455
	Failure Mode and Effect and/or Criticality Analysis (FMEA &/or FMECA) for process design	Yes	1	0	0	1	0	1	1	1	1	0	0	1	0	1	0	0	0	0	0	1	1	1	11	50.00
		No	0	1	1	0	0	0	0	0	0	1	1	0	1	0	1	1	0	1	1	0	0	0	9	40.91
		Rating	0	3	5	0	0	0	7	4	5	3	3	6	0	6	3	5	4	3	3	0	0	5	4.333333333
	Hazard Analysis and Operability Study (HAZOP)	Yes	1	0	0	0	0			0	0	1	0	0	0	0	0	0	0	0	1	0	0	1	4	18.18
		No	0	1	1	1	1			1	1	0	1	1	1	1	1	1	1	1	0	0	1	0	15	68.18
		Rating	0	3	2	3	0			2		0	2	4	0	4	3	5	1	2	0	0	2	5	2.923076923
	Hazard Analysis and Critical Control Point (HACCP)	Yes	0	0	0	0	0	0		0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	4.55
		No	1	1	1	1	1	1		1	0	1	1	1	1	1	1	1	1	1	1	0	1	1	19	86.36
		Rating	2	3	2	3	0	0		2	7	3	3	4	0	4	3	5	1	2	2	0	2	2	2.941176471
	List tools other than above				Mix FTA & FMEA														Software Hazard Mgmt Plan

RISK MANAGEMENT PROCESS
																									Total	% Total
5	How does your procedure determine risk acceptability?
	None		0	0	0	0			0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	2	9.09
	Use risk priority number (RPN)		0	1	1	1			1	1	1	1	0	1	0	1	0	0	0	1	1	1	0	1	13	59.09
	Use risk chart concept		1	0	1	0			0	0	0	0	0	0	1	0	1	0	1	0	0	1	1	1	8	36.36
	List other means		0	0	0	0			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

6	How often d
	None		0	0	0	0			0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	2	9.09
	Once		0	0	0	1			1	0	0	1	1	1	1	1	1	0	0	1	1	0	1	1	12	54.55
	2-3 times		1	1	1	0			0	1	1	0	0	0	0	0	0	0	1	0	0	1	0	0	7	31.82
	4-5 times		0	0	0	0			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0.00
	> 5 times		0	0	0	0			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0.00

7	How often do your procedures require formal risk review during the lifetime of a product?
	None		1	0	0	0			0	1	0	1	0	0	0	0	0	1	0	0	0	0	1	0	5	22.73
	Once		0	1	1	1			0	0	0	0	1	1	1	1	1	0	0	0	0	0	0	1	9	40.91
	2-3 times		0	0	0	0			1	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	3	13.64
	4-5 times		0	0	0	0			0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	4.55
	> 5 times		0	0	0	0			0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	2	9.09

POST-PRODUCTION INFORMATION
																									Total	% Total
8	How do your complaint-handling procedures link back to your initial risk analysis?
	No link		0	0	1	1	1	1	0	0	1	1	0	1	1	1	0	1	0	1	0	0	1	1	13	59.09
	Manual interpretation		0	1	0	0	0	0	1	1	0	0	1	0	0	0	1	0	0	0	1	0	0	0	6	27.27
	Coded events with risks		1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	2	9.09
	Tailored software		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0.00
	List other means		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	Annual Design Review incorporating complaint history @ min.	0	0

9	How do your CAPA procedures link back to your initial risk analysis?
	No link		0	0	1	1	1	1	0	0	0	1	1	0	1	0	0	1	0	1	1	0	1	1	12	54.55
	Manual interpretation		0	1	0	0	0	1	1	1	1	0	0	1	0	1	1	0	0	0	0	0	0	0	8	36.36
	Coded events with risks		1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	2	9.09
	Tailored software		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0.00
	List other means		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	Annual Design Review incorporating CAPA @ min.	0	0

10	How do your validation procedures link back to your initial risk analysis?
	No link		0	0	0	1	1	1	0	0	0	1	1	0	1	0	0	0	0	0	0	0	0	0	6	27.27
	Manual interpretation		0	1	0	0	0	0	1	0	1	0	0	1	0	1	1	1	0	1	1	1	0	0	10	45.45
	Coded testing with risks		1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	1	0	4	18.18
	List other means		0	0	Procedure for Design Contl Rqt.	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	Evaluate I/P vs O/P during design contl

RISK MANAGEMENT IMPLEMENTATION
																									Total	% Total
11	When did your company start implementation of the standard?
	Not prepared yet		1	0	0	0	1	1	0	1	1	1	1	0	1	0	1	1	0		1	0	0	1	12	54.55
	Within a year		0	1	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0		0	1	0	0	4	18.18
	2 years ago		0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0		0	0	0	0	1	4.55
	> 2 years ago		0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	1		0	0	1	0	4	18.18

12	How long was the implementation period from start to finish?
	3 months		0	0	0	1	0		0					0		0			0			0	0	0	1	4.55
	6 months		0	0	0	0	0		1					0		0			0			1	0	0	2	9.09
	~ 1 year		0	0	1	0	0		0					0		0			0			0	1	1	3	13.64
	> 1 year		1	1	0	0	1?		0					1		1			1			0	0	0	5	22.73

13	How much and what resources are assigned?
	Cross functional team		0	0	1	1			0	0			0	1		1			0		0	1	0	1	6	27.27
	Ad hoc team		0	0	0	0			0	0			0	0		0			0		0	0	0	0	0	0.00
	Internal Champion		1	1	0	0			1	1			1	0		0			1		1	1	0	0	8	36.36
	External Consultant		0	0	0	0			0	0			0	0		0			1		0	1	1	0	3	13.64

14	What are the major challenges of your implementation?
	None		0	0	0	0			0	0	1	0	0	0		0	0		0		0	0	0	0	1	4.55
	Budget/Resource/Constraints		0	0	0	0			0	0	0	1	0	0		0	1		0		0	0	0	0	2	9.09
	Management commitment and understanding		1	1	1	1			1	1	0	1	1	1		1	1		0		1	1	0	0	13	59.09
	Paradigm shift from current risk analysis system		1	1	0	0			0	0	0	1	1	1		1	0		1		0	0	0	1	8	36.36
	Effective use of risk assessment tools		0	1	0	0			0	1	0	1	1	0		0	1		0		0	1	1	0	7	31.82
	List other challenges		0	0	0	0			0	0	0	0	0	0		0	0		0		0	Diff. Individual perspectives & experiences	0	0

15	What are the major element(s) of success in your implementation?
	None		1	1	0	1			0		1	1	0	0		0	0		0		0	0	0	0	5	22.73
	Empowering risk policy		0	0	0	0			1		0	0	0	0		0	0		1		0	0	0	1	3	13.64
	Standardized hazard list(s)		0	0	1	0			0		0	0	1	1		1	1		0		1	0	0	0	6	27.27
	Aligned risk communication		0	0	0	0			0		0	0	0	0		0	0		0		0	0	0	0	0	0.00
	Simplified decision making process for product issues		0	0	0	0			0		0	0	0	0		0	1		1		0	1	0	0	3	13.64
	Reduced or eliminated inspections through effective and preventive risk control measures		0	0	0	0			0		0	0	0	0		0	1		1		0	0	1	0	3	13.64
	List other elements of success		0	0	0	0			0		0	0	0	0		0	0		0		0	Simplicity	0	0