A02 SOW Attachment 3 System Safety IECU.pdf

Attachment 003

STATEMENT OF WORK

SYSTEM SAFETY

1. System safety requirements. The contractor shall establish and maintain system safety processes, procedures and a program to integrate hazard identification, assessment, and elimination or control into the product design and production effort required by this contract. The program shall support all design, engineering, analysis, test, production, fielding, sustainment and disposal activities during the conduct of this contract. The contractor shall perform System Safety IAW MIL-STD-882E and DA PAM 385-16.

Army standards, specifications, regulations, design handbooks, safety design checklists, and other sources of design guidance shall be reviewed for pertinent safety design requirements applicable to the Family of Improved Environmental Control Units (9-18-

36K IECU). The contractor shall support IECU System Safety Working Group (SSWG) meetings and telecoms. The contractor shall support meetings and documentation required for Milestone decisions and Material Releases IAW AR 770-2 and AR 770-3.

The contractor shall incorporate safety design criteria for developing system specification safety requirements. Some general system safety design requirements are:

a. Identified hazards, including health hazards and environmental hazards, shall be eliminated or associated risk shall be reduced through design, including material/component selection or substitution. Hazards shall be documented in the Safety

Assessment Report (SAR) and Hazard Tracking System. The Hierarchy of Controls shall be utilized in the development of the system to abate identified hazards (Elimination, Engineering Controls, Administrative Controls, Personal Protection Equipment (PPE)).

Elimination and engineering controls should be the priority.

b. Hazardous component(s) and operation(s) shall be isolated from other activities, areas, and personnel.

c. Equipment shall be located so that access during operations, servicing, maintenance, repair, or adjustment minimizes personnel exposure to hazards (e.g. hazardous/energized components, high temperature, cutting edges, or sharp points).

d. Risk resulting from human error in system operation shall be minimized as part of the design effort.

e. When alternate design approaches cannot eliminate the hazard, safety warning and cautionary notes shall be provided in assembly, operations, maintenance and repair instructions, and distinctive markings shall be provided on hazardous components and equipment to ensure personnel protection. These shall be standardized in accordance with commonly accepted commercial practice or normal military procedures.

f. The severity of personnel injury or damage to equipment as a result of a mishap shall be minimized.

2. System safety precedence. The order of precedence for satisfying system safety requirements and resolving identified hazards shall be as follows:

a. Design for minimum risk. Eliminate hazards through design. If an identified hazard cannot be eliminated, reduce the associated risk to an acceptable level through design selection.

b. Incorporate safety devices. Reduce the hazard to a level acceptable through engineering controls through the use of fixed, automatic, or other protective safety design features or devices. Provisions shall be made for periodic functional checks of safety devices when applicable.

c. Provide warning devices. Use devices to detect the condition and to produce an adequate warning signal to alert personnel of the hazard. Warning signals and their application shall assure a minimal probability of incorrect personnel reaction to the signal.

d. Develop procedures and training. Procedures and training shall be used where it is impractical to eliminate hazards through design selection or adequately reduce the associated risk with safety and warning devices. However, use of danger, warning, caution, or other written advisory shall not be used as the only risk reduction method for

Category I or II hazards IAW MIL-STD-882E. Procedures may include the use of personal protective clothing/equipment, i.e., thermal insulated gloves, eye, or face protection or other PPE. PPE should be the last resort to mitigate a hazard.

3. Risk assessment. Decisions regarding resolution of identified hazards shall be based on assessment of the risk involved. MIL-STD-882E shall be used. To aid the achievement of the objectives of system safety, hazards shall be characterized as to hazard severity categories and hazard probability levels. When hazards are not eliminated during the early design phase, a risk assessment procedure based upon the hazard probability, hazard severity, as well as risk impact, shall be used to establish priorities for corrective action and resolution of identified hazards. Residual risk shall be reduced to a MEDIUM level (2-E, 3-D, 4-B or less). The initial risk before controls are put in place shall be documented.

4. Safety Risk Evaluation. The contractor shall perform a comprehensive and detailed evaluation of the safety risk being assumed by the government through the operation and maintenance of the contractor's product. The contractor's evaluation shall identify all safety features of the system design, identify specific nationally recognized safety related standards or test laboratories the system or its components comply with, and verify compliance with safety requirements of the Government's performance purchase description. In addition, the contractor shall identify and evaluate any procedural or design related hazards that may be present in the system, and develop the specific controls and precautions that should be followed during system use to prevent personnel injury or equipment damage. Health related hazards (e.g., noise, hazardous chemicals, toxic substances), as well as physical hazards shall be addressed.

4.1 Safety Assessment Report. The contractor shall prepare, update and maintain the

Safety Assessment Report (SAR) for the IECU that provides a comprehensive evaluation of the complete system. The results of the contractor's safety risk evaluation shall be submitted to the government in a Safety Assessment Report in accordance with this SOW and Exhibit A. Contractor format may be used but the content shall include the information specified in DI-SAFT-80102C. The hazard list specified in DI-SAFT-80102C shall include the following information for each hazard, as a minimum:

a. Description of the hazard.

b. Initial hazard risk assessment code (see paragraph 4, below).

c. Actions taken or required to eliminate or control the hazard (e.g., design changes, warning or caution signs on the equipment, safe procedures and precautions in technical manuals).

d. Final hazard or residual risk assessment code, which takes into account the control measure.

e. Status of corrective action (i.e., indicate if actions are complete, or identify any remaining actions necessary to resolve the hazard). Contractor shall be specific as to where the mitigation is documented if using warning in technical manuals or training materials.

4.1.1 The hazard risk assessment code for each hazard identified shall be assigned by using the definitions and matrix given below.

a. Definitions for hazard severity.

(1) Category 1 - Catastrophic; the total destruction of the system, or an injury or occupational illness resulting in a fatality or permanent total disability, or irreversible significant environmental impact (irreversible severe damage that violates law), or monetary loss equal to or exceeding $10M.

(2) Category 2 - Critical; Could result in one or more of the following: permanent partial disability, injuries, or occupational illness that may result in hospitalization of at least three personnel, reversible significant environmental impact (POL leak above reportable quantities or irreversible damage but not violate law (inadvertent release of materials with high global warming potential)), or monetary loss equal to or exceeding $1M but less than $10M

(3) Category 3 - Marginal; minor system damage requiring maintenance that would cause down time beyond the day, minor injury causing loss of time from work beyond the day or shift, or minor occupational illness causing loss from work or disability at any time or reversible moderate environmental impact (reversible damage without violation of law (release of hazardous materials below reportable quantities), or monetary loss equal to or exceeding $100K but less than $1M.

(4) Category 4 - Negligible; Could result in one or more of the following: injury or occupational illness not resulting in a lost workday, minimal environmental impact (unnecessary vehicle fluid changes), or monetary loss less than $100K.

b. Definitions for hazard probability.

(1) Category A - Frequent; likely to occur frequently (continually experienced in the inventory).

(2) Category B - Probable; will occur several times (will occur frequently within the inventory).

(3) Category C - Occasional; likely to occur some time (will occur several times within the inventory).

(4) Category D - Remote; unlikely but possible to occur (unlikely but can reasonably be expected to occur within the inventory).

(5) Category E - Improbable; so unlikely, it can be assumed occurrence may not be experienced (unlikely to occur within the inventory, but possible).

c. Hazard risk assessment code. The hazard risk assessment code is a combination of the hazard severity and hazard probability categories as depicted in the following table.

Risk Acceptance Levels per DoDI 5000.02, 08

June 2022.

Risk Assessment Levels & Definitions Per

Tables I, II and III of MIL-STD 882E, 27

September 2023.

HAZARD SEVERITY

Catastrophic Critical Marginal Negligible

S p e c if ic I n d iv id u a l

I te m

F le e t o r I n v e n to r y

Could result in one or more of the following:

death, permanent total disability, irreversible significant environmental impact (irreversible severe damage that violates law), or monetary loss equal to or exceeding $10M.

Could result in one or more of the following:

permanent partial disability, injuries, or occupational illness that may result in hospitalization of at least three personnel, reversible significant environmental impact (POL leak above reportable quantities or irreversible damage but not violate law (inadvertent release of materials with high global warming potential)), or monetary loss equal to or exceeding $1M but less than $10M.

Could result in one or more of the following: injury or occupational illness resulting in one or more lost workdays, reversible moderate environmental impact (reversible damage without violation of law (release of hazardous materials below reportable quantities), or monetary loss equal to or exceeding $100K but less than $1M.

Could result in one or more of the following:

injury or occupational illness not resulting in a lost workday, minimal environmental impact (unnecessary vehicle fluid changes), or monetary loss less than $100K.

1 2 3 4

H A

Z A

R D

P R

O B

A B

I L I T Y

F r e q u e n t

Like to occur often in the life of the item

Continuously experienced A 1-A

HIGH

CAE

2-A

HIGH

CAE

3-A

SERIOUS

PEO

4-A

MEDIUM

PM

P r o b a b le Will occur several times in the life of the item

Will occur frequently B 1-B

HIGH

CAE

2-B

HIGH

CAE

3-B

SERIOUS

PEO

4-B

MEDIUM

PM

O c c a s io n a l

Likely to occur sometime in the life of the item

Will occur several times C 1-C

HIGH

CAE

2-C

SERIOUS

PEO

3-C

MEDIUM

PM

4-C

LOW

PM

R e m o te

Unlikely, but possible to occur in the life of the item

Unlikely, but can reasonably be expected to occur

D 1-D

SERIOUS

PEO

2-D

MEDIUM

PM

3-D

MEDIUM

PM

4-D

LOW

PM

I m p r o b a b le

So unlikely, it can be assumed occurrence may not be experienced in the life of the item.

Unlikely to occur, but possible E

1-E

MEDIUM

PM

2-E

MEDIUM

PM

3-E

MEDIUM

PM

4-E

LOW

PM

E li m in a te d

Incapable of occurrence. This level is used when potential hazards are identified and later eliminated

F Eliminated

RAC Risk

Level

Acceptance Authority

1-A, 1-B, 1-C, 2-A, 2-B HIGH Component Acquisition Executive

(CAE), Defense Acquisition Executive

(DAE) or designee

1-D, 2-C, 3-A, 3-B SERIOUS Program Executive Officer (PEO) or equivalent

1-E, 2-D, 2-E, 3-C, 3-D, 3-E, 4-A, 4-B

MEDIUM Product Manager (PM) or equivalent

4-C, 4-D, 4-E LOW Product Manager (PM) or equivalent