Design and Development
Supplier Issues Product/Material Control
Engineering / Sales
Procedures / Work Instructions / Mgmt.. Syst. Tools
Communication
Supervision
Training / Risk Assessment
Problem Identification / Control
Human Factors

Design and Development

All aspects of the design and development process including product and test equipment for parts materials and processes.

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Supplier Issues Product/Material Control

Actions NOT directly related to the product realization process.

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Engineering / Sales

Capabilities of personnel in the development of design, development and control of systems.

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Procedures / Work Instructions / Mgmt.. Syst. Tools

Procedure / WI /Diagrams critical to the realization process.

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Communication

Act of exchanging information. Addresses informal methods such as face to face, emails, phone, etc.

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Supervision

Supervisors are accountable for adequate Job planning/preparation/Walk through.

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Training / Risk Assessment

Critical training shall be identified and provided.

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Problem Identification / Control

Problems must be recorded and reported in order to make sure elimination and recurrence.

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Human Factors

Personal factors, perceptions, influences with adherence behaviors in employees.

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Supplier Issues Product/Material
Control

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Supplier Issues

Issues found with supplied products that must be sent back to suppliers.
Supplier Issues Product/Material Control | Supplier Issues

Product/Material requirements NOT met

Supplier Issues Product/Material Control | Supplier Issues

Data book incomplete (Traceability identification)

Supplier Issues Product/Material Control | Supplier Issues

Supplier Documentation / Records not completed

Supplier Issues Product/Material Control | Supplier Issues

Products/Materials failed the inspection process

Supplier Issues Product/Material Control | Supplier Issues

Insufficient evidence of required tests performed

Supplier Issues Product/Material Control | Supplier Issues

Vague Quality Requirements (Not clearly stablished)

Supplier Issues Product/Material Control | Supplier Issues

Visual inspection criteria not met

Supplier Issues Product/Material Control | Supplier Issues

Outdated Specifications

Supplier Issues Product/Material Control | Supplier Issues

Lack of participation in Validation

Preservation

Handling & Storage appropriate for the product.
Supplier Issues Product/Material Control | Preservation

Inappropriate Handling / Storage

Supplier Issues Product/Material Control | Preservation

Shelf life of material and products can be exceeded (EXPIRED)

Supplier Issues Product/Material Control | Preservation

Unauthorized material substitution affecting the final product

Supplier Issues Product/Material Control | Preservation

Materials and products damaged

Supplier Issues Product/Material Control | Preservation

Inadequate or inappropriate equipment used for handling the product

Supplier Issues Product/Material Control | Preservation

Location for storing NOT appropriate for the product

Supplier Issues Product/Material Control | Preservation

Inadequate inspection upon receiving the product at location

Supplier Issues Product/Material Control | Preservation

Mix-up of products due to inadequate tagging system

Packaging / Shipping

Ensure adequate packaging and shipping of the product to prevent any damage to product.
Supplier Issues Product/Material Control | Packaging/Shipping

Product (Material) not packaged in a prudent and practical manner

Supplier Issues Product/Material Control | Packaging/Shipping

Exposure to adverse conditions and/or damaged packaging

Supplier Issues Product/Material Control | Packaging/Shipping

Material was damaged during shipping

Supplier Issues Product/Material Control | Packaging/Shipping

Packaged not adequate for the product/conditions

Supplier Issues Product/Material Control | Packaging/Shipping

Packaged not adequate for the conditions

Supplier Issues Product/Material Control | Packaging/Shipping

Inadequate Handling during shipping

Supplier Issues Product/Material Control | Packaging/Shipping

No inspection and documentation review in the shipping state

Supplier Issues Product/Material Control | Packaging/Shipping

No inspection and documentation review in the shipping state

Product acceptance criteria

Acceptance Criteria for a manufactured part supplied, a product purchased or made by the organization.
Supplier Issues Product/Material Control | Product acceptance criteria

Acceptance Criteria NOT Stablished between Company and Vendor

Supplier Issues Product/Material Control | Product acceptance criteria

Acceptance criteria NOT adequately communicated to vendor/personnel

Supplier Issues Product/Material Control | Product acceptance criteria

Testing procedure and/or related acceptance criteria was not clearly established

Supplier Issues Product/Material Control | Product acceptance criteria

Design acceptance criteria not aligned with Manufacture AC

Supplier Issues Product/Material Control | Product acceptance criteria

Acceptance Criteria incomplete

Supplier Issues Product/Material Control | Product acceptance criteria

Testing procedures not known

Supplier Issues Product/Material Control | Product acceptance criteria

Inadequate Identification of needs (Vendors/Customers)

Supplier Issues Product/Material Control | Product acceptance criteria

Inadequate contractor selection

Supplier Issues Product/Material Control | Product acceptance criteria

Inadequate contract / post contract meeting

Inspection process / Reasonable Expectations

Inspection process, whether incoming, in-process, or final - Must have a defined Accept. Criteria, and Instructions of requirements.
Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Inspection of materials/products was NOT performed

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Inspection of materials was NOT performed in accordance to testing procedures

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Product not tested in accordance with the inspection and test plan

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Inspection requirements Not implemented

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Unacceptable material or product Is not appropriately identified and isolated to

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

No hold point

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Hold point not performed

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Inspection Not required

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Inspection procedures needs improvement

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Component failures a result of "Testing to failure"

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Testing / Operating conditions are beyond design criteria

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Re-work or multiple re-works

Supplier Issues Product/Material Control | Inspection process / Reasonable Expectations

Failure expected in the normal operations

Inadequate Logistics / Delivery

Detailed coordination of operations involving people, facilities and supplies.
Supplier Issues Product/Material Control | Inadequate Logistics / Delivery

Inadequate package / container

Supplier Issues Product/Material Control | Inadequate Logistics / Delivery

Inadequate papers / documentation

Supplier Issues Product/Material Control | Inadequate Logistics / Delivery

Inadequate customs clearance

Supplier Issues Product/Material Control | Inadequate Logistics / Delivery

Inadequate transportation (mode, availability, standard, specs)

Supplier Issues Product/Material Control | Inadequate Logistics / Delivery

Inadequate storage / warehousing

Supplier Issues Product/Material Control | Inadequate Logistics / Delivery

Inadequate handling / Manipulation

Supplier Issues Product/Material Control | Inadequate Logistics / Delivery

Insufficient / inadequate shipment / goods / load delivery

Engineering/Sales

Capabilities of personnel in the development of design, development and control of systems.

Fault intolerant conditions

Conditions - Error is not easily detectable (before the event) or correctable (After).
Engineering/Sales | Fault intolerant conditions

Special processes required

Engineering/Sales | Fault intolerant conditions

Components used in the assembly are not individually marked. Incorrect part

Engineering/Sales | Fault intolerant conditions

Location where defects occurred were not able to be inspected

Engineering/Sales | Fault intolerant conditions

Inadequate controls in place

Engineering/Sales | Fault intolerant conditions

Technicians not attentive to their work

Engineering/Sales | Fault intolerant conditions

Misplacement

Engineering/Sales | Fault intolerant conditions

Inspection not recorded

Engineering/Sales | Fault intolerant conditions

Lack of order, housekeeping due to human factors

Workplace layout

Exposure to different operating conditions. (Equipment setup, Layout and people.
Engineering/Sales | Workplace layout

Similar pieces of equipment do not function in similar manner

Engineering/Sales | Workplace layout

Equipment have gauges that do not have the required accuracy

Engineering/Sales | Workplace layout

No inspection requirements are identified on purchase orders

Engineering/Sales | Workplace layout

Labeling schemes not consistent

Engineering/Sales | Workplace layout

Equipment used not reliable

Engineering/Sales | Workplace layout

Inconsistent layout or operation of test equipment or measurement devices

Engineering/Sales | Workplace layout

Difficult to read measuring devices or do not have adequate accuracy

Work Environment (Ambient condition)

Includes exposure of personnel, products or materials that can adversely affect the product quality.
Engineering/Sales | Work Environment (Ambient condition)

Extreme temperature in the workplace - Affect personnel performance or properties of product/material

Engineering/Sales | Work Environment (Ambient condition)

Low lighting levels - Affects personnel performance

Engineering/Sales | Work Environment (Ambient condition)

High noise conditions

Engineering/Sales | Work Environment (Ambient condition)

Lack of ventilation

Engineering/Sales | Work Environment (Ambient condition)

Work Environment

Engineering/Sales | Work Environment (Ambient condition)

Housekeeping needs improvement

Engineering/Sales | Work Environment (Ambient condition)

Obstructions

Engineering/Sales | Work Environment (Ambient condition)

Equipment guards needs improvement

Engineering/Sales | Work Environment (Ambient condition)

High contamination

Unrealistic monitoring requirement

Level of monitoring required is too complex, too detailed or involve too many attributes.
Engineering/Sales | Unrelaistic monitoring requirement

Equipment controls are so complex that contributes to failure

Engineering/Sales | Unrelaistic monitoring requirement

Too many variables to monitor

Engineering/Sales | Unrelaistic monitoring requirement

Change of methods for monitoring

Engineering/Sales | Unrelaistic monitoring requirement

Loss of alertness of the employee

Engineering/Sales | Unrelaistic monitoring requirement

Excessive length of time to monitor a task

Engineering/Sales | Unrelaistic monitoring requirement

Complex methods to monitor the task

Engineering/Sales | Unrelaistic monitoring requirement

Too many number of monitoring points (unnecessary)

Excessive data manipulation required

Not intuitive, too many variables to memory and make decision based on gut feeling, infrequently observed conditions.
Engineering/Sales | Excessive data manipulation required

Monitoring issues were not considered in the design process

Engineering/Sales | Excessive data manipulation required

Complicated logic sequence

Engineering/Sales | Excessive data manipulation required

Extended amounts of information to memory

Engineering/Sales | Excessive data manipulation required

Complicated information

Engineering/Sales | Excessive data manipulation required

Conditions not anticipated by employee

Engineering/Sales | Excessive data manipulation required

Process for clearing an upset condition was not clearly defined

Inadequate Marketing and Sales

The action of promoting and selling products and services.
Engineering/Sales | Inadequate Marketing and Sales

Inadequate understanding of market needs

Engineering/Sales | Inadequate Marketing and Sales

Inadequate development of client relationships

Engineering/Sales | Inadequate Marketing and Sales

Inadequate customer satisfaction monitoring

Engineering/Sales | Inadequate Marketing and Sales

Inadequate knowledge of competitors

Engineering/Sales | Inadequate Marketing and Sales

Inadequate communications of capabilities / technologies

Engineering/Sales | Inadequate Marketing and Sales

Inadequate response to service delivery failures / complaints

Engineering/Sales | Inadequate Marketing and Sales

Inadequate understanding / appreciation of operational capabilities

Engineering/Sales | Inadequate Marketing and Sales

Overselling / over promising

Procedures / Work Instructions / Management System Tools

Procedure / WI /Diagrams critical to the realization process.

Not followed or not available

P/WI/D required shall be available and followed.

Procedures / Work Instructions / Management System Tools| Not followed or not available

P/WI/D was NOT available

Procedures / Work Instructions / Management System Tools| Not followed or not available

P/WI/D NOT used/followed

Procedures / Work Instructions / Management System Tools| Not followed or not available

Task performed infrequently

Procedures / Work Instructions / Management System Tools| Not followed or not available

Steps of the process not described in detail

Procedures / Work Instructions / Management System Tools| Not followed or not available

Error in sequence of steps

Procedures / Work Instructions / Management System Tools| Not followed or not available

Steps of the process NOT easily remembered

Procedures / Work Instructions / Management System Tools| Not followed or not available

Inadequate Maintenance of P/WI/D (Tracking, updating, monitoring)

Procedures / Work Instructions / Management System Tools| Not followed or not available

Procedure difficult to use

Procedures / Work Instructions / Management System Tools| Not followed or not available

Procedure use not required but should

No procedure – but should have one

The need of a procedure NOT identified.
Procedures / Work Instructions / Management System Tools| No procedure - but should have one

NO Procedure/Work Instruction/Drawing

Procedures / Work Instructions / Management System Tools| No procedure - but should have one

The need of a P/W/D was NOT identified

Procedures / Work Instructions / Management System Tools| No procedure - but should have one

Assumption that the process is logical and obvious (wrong)

Procedures / Work Instructions / Management System Tools| No procedure - but should have one

Process has been introduced and P/W/D was not yet been developed

Procedures / Work Instructions / Management System Tools| No procedure - but should have one

Inventory and evaluation of exposures and needs

Procedures / Work Instructions / Management System Tools| No procedure - but should have one

No procedure/practice rules

Inadequate / wrong

P/WI/D NOT adequate, insufficient information.
Procedures / Work Instructions / Management System Tools| Inadequate / wrong

P/WI/D NOT adequate / Wrong. Ambiguous instructions

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

P/WI/D do NOT contain sufficient information

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

Wrong sequence of steps

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

The instructions did not adequately describe what actions or information

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

Set of Steps missing in the P/W/D

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

P/WI/D difficult to follow

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

Organization failed to address statutory/regulatory requirements

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

Scope of P/WI/D NOT well defined

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

P/WI/D does not refers others P/WI/D that do contain the data

Procedures / Work Instructions / Management System Tools| Inadequate / wrong

P/WI/D contains inadequate checklist

Confusing

Personnel may become confused by lack of consistency and clarity.
Procedures / Work Instructions / Management System Tools| Confusing

Steps are difficult to follow

Procedures / Work Instructions / Management System Tools| Confusing

Steps do not follow a logical sequence

Procedures / Work Instructions / Management System Tools| Confusing

Instructions can be interpreted in more that one way

Procedures / Work Instructions / Management System Tools| Confusing

Insufficient information (too brief)

Procedures / Work Instructions / Management System Tools| Confusing

Poor quality or misleading P/WI/D

Procedures / Work Instructions / Management System Tools| Confusing

Checklist missing

Procedures / Work Instructions / Management System Tools| Confusing

Format is confusing

Procedures / Work Instructions / Management System Tools| Confusing

Excess of references

Procedures / Work Instructions / Management System Tools| Confusing

Inadequate Monitoring of compliance

Procedures / Work Instructions / Management System Tools| Confusing

Situation not covered

Not revised

P/WI/D have NOT been updated/revised to meet specific customer requirements.

Procedures / Work Instructions / Management System Tools| Not revised

P/WI/D NOT updated to specific customer requirements

Procedures / Work Instructions / Management System Tools| Not revised

Specific Customer requirements not revised/communicated

Procedures / Work Instructions / Management System Tools| Not revised

Specific Customer requirements not communicated

Procedures / Work Instructions / Management System Tools| Not revised

Details of product requirements not changed

Procedures / Work Instructions / Management System Tools| Not revised

Current revised document not created

Procedures / Work Instructions / Management System Tools| Not revised

Common knowledge that a process has changed, NO revised procedure developed

Procedures / Work Instructions / Management System Tools| Not revised

Old versions / Obsolete NOT removed / replaced / destroyed

Procedures / Work Instructions / Management System Tools| Not revised

No MOC applied when necessary

Procedures / Work Instructions / Management System Tools| Not revised

Inadequate sharing of current P/WI/D

Procedures / Work Instructions / Management System Tools| Not revised

New not adequately implemented

Procedures / Work Instructions / Management System Tools| Not revised

Current revised document incomplete

Procedures / Work Instructions / Management System Tools| Not revised

Current revised document incorrect

Management System Tools

Framework of Policies / Stds. including processes and/or Adm. controls.

Procedures / Work Instructions / Management System Tools| Management System Tools

NO Standards and Policies

Procedures / Work Instructions / Management System Tools| Management System Tools

MS confusing

Procedures / Work Instructions / Management System Tools| Management System Tools

MS incomplete

Procedures / Work Instructions / Management System Tools| Management System Tools

Standards/Policies recently changed

Procedures / Work Instructions / Management System Tools| Management System Tools

MS ST and Policies not implemented

Procedures / Work Instructions / Management System Tools| Management System Tools

MS accountability needs improvement

Procedures / Work Instructions / Management System Tools| Management System Tools

Infrequent Audits & Evaluations

Procedures / Work Instructions / Management System Tools| Management System Tools

Audits & Evaluations lack of depth

Procedures / Work Instructions / Management System Tools| Management System Tools

No employee feedback

Communication

Act of exchanging information. Addresses informal methods such as face to face, emails, phone, etc.

Between groups / shifts / locations

Can include miscommunication and/or communication not provided.
Communication| Between groups / shifts / locations

Communication is NOT provided in a consistent manner to all departments

Communication| Between groups / shifts / locations

Shifts do not adequately communicate critical aspects

Communication| Between groups / shifts / locations

Policies and Procedures not effectively communicated to all

Communication| Between groups / shifts / locations

Customer requirements not communicated in a timely manner

Communication| Between groups / shifts / locations

Employee concerns are not communicated to management

Communication| Between groups / shifts / locations

Log book not used to communicate key issues between shifts

Communication| Between groups / shifts / locations

No Suggestion box in place for the facility

Changes NOT communicated to all shifts or NOT effectively communicated

Communication| Between groups / shifts / locations

Verbal instructions not understood

Communication| Between groups / shifts / locations

Inadequate distribution of P/WI/D

With Customer or vendor

The Organization must constantly stay in touch with vendors and its customers.
Communication| With Customer or vendor

Customer requirements NOT communicated

Communication| With Customer or vendor

Changes to customer requirements NOT communicated effectively

Communication| With Customer or vendor

Changes to customer requirements NOT communicated to vendors

Communication| With Customer or vendor

Changes in the vendors ability to meet requirements NOT communicated

Communication| With Customer or vendor

Phone calls, emails, etc. NOT answered in a timely manner

Communication| With Customer or vendor

Poor communication with suppliers or Vendors

Communication| With Customer or vendor

Not having assigned a person responsible to communicate

Misunderstood communications

The Organization shall ensure the effective communication is in place.
Communication| Misunderstood communications

Oral instructions are given when written instructions should have been provided

Communication| Misunderstood communications

The giver and recipient of oral communication NOT "on the same wave length

Communication| Misunderstood communications

Slang, abbreviations or similar jargon caused communication breakdown

Communication| Misunderstood communications

Standard terminology NOT used NOT understood

Communication| Misunderstood communications

Repeat back of instructions NOT used (feedback)

Communication| Misunderstood communications

Noisy environment

Communication| Misunderstood communications

Language barrier

Communication| Misunderstood communications

Incorrect instructions provided

Communication| Misunderstood communications

Inadequate matching of individual qualifications and job/task requirements

Wrong instructions

Supervision shall provide clear and adequate instructions.
Communication| Wrong instructions

Customer specific requirements NOT communicated

Communication| Wrong instructions

Supervision assume certain "facts"

Communication| Wrong instructions

Revised instructions and procedures NOT communicated

Communication| Wrong instructions

Wrong instructions were provided

Communication| Wrong instructions

Wrong method of communication

Communication| Wrong instructions

Communication not clear/adequate

Personnel turnover

Non Conformance can be the result of Employee turnover or unexpected absence.
Communication| Personnel turnover

High turnover of personnel changing the work environment

Communication| Personnel turnover

Untrained worker assigned to perform the task due to employee turnover

Communication| Personnel turnover

Unexpected absenteeism can cause a shift in the assignments

Communication| Personnel turnover

Jobs being performed by multiple shifts

Communication| Personnel turnover

Communication between shifts

Communication| Personnel turnover

Rapid growth in the organization

Communication| Personnel turnover

Changes in supervisors

Communications methods

Inadequate communication methods or exchanging of information.
Communication| Communications methods

No communication methods or inadequate

Communication| Communications methods

Inadequate message length (Too short, too long)

Communication| Communications methods

Verification/repeat feedback not used

Communication| Communications methods

Speech interference

Communication| Communications methods

Inadequate communication due to job turn over

Communication| Communications methods

Inadequate communication of safety, health data or regulations

Communication| Communications methods

Standard terminology not used

Communication| Communications methods

No communication skills/knowledge

Supervision

Supervisors are accountable for adequate Job planning/preparation/Walk through.

Job Planning or Preparation

Job Planning/Preparation NOT done.
Supervision| Job Planning or Preparation

Inadequate Job Planning/Preparation

Supervision| Job Planning or Preparation

Potential problems NOT identified prior to job execution

Supervision| Job Planning or Preparation

Assumption that job was understood

Supervision| Job Planning or Preparation

Supervisor fails to ensure that all resources are provided

Supervision| Job Planning or Preparation

Assumption is made that process have NOT changed

Supervision| Job Planning or Preparation

Failure to identify and mitigate Risks

Supervision| Job Planning or Preparation

Lack of communication of customer requirements

Supervision| Job Planning or Preparation

Inadequate long term planning

Resource Scheduling Problems

Management is responsible to supply adequate resources including personnel.
Supervision| Resource Scheduling Problems

Resources shortfall

Supervision| Resource Scheduling Problems

Work NOT performed when schedule

Supervision| Resource Scheduling Problems

Product/Parts/Raw Material delivery dates NOT met

Supervision| Resource Scheduling Problems

Process capabilities could not meet production requirements

Supervision| Resource Scheduling Problems

Lack of personnel for shift

Supervision| Resource Scheduling Problems

Timing not met. (Not planned, evaluated and/or coordinated)

Supervision| Resource Scheduling Problems

Inadequate selection of worker

Worker Selection

Proper work planning includes assigning qualified personnel for the different tasks.
Supervision| Worker Selection

Qualified worker for the job NOT selected

Supervision| Worker Selection

Workers assigned NOT competent for task assigned

Supervision| Worker Selection

Insufficient number of trained employees for the task

Supervision| Worker Selection

Employee was expected to perform task without the appropriate training

Supervision| Worker Selection

Credentials of employee performing tasks not verified

Supervision| Worker Selection

Supervisor does NOT have the resources to determine if worker is qualified

Supervision| Worker Selection

Supervisor does NOT qualified to determine worker's competency

Supervision| Worker Selection

New employee issue, expected to perform as experienced employee

Supervision| Worker Selection

Inadequate matching of individual qualifications and job/task requirements

Performance not corrected

The Organization shall NOT allow substandard work.
Supervision| Performance not corrected

Poor performance NOT corrected

Supervision| Performance not corrected

NOT properly addressing Non Conformities

Supervision| Performance not corrected

Supervision allows improper performance

Supervision| Performance not corrected

Supervision ignores systemic conditions

Supervision| Performance not corrected

Supervision does NOT take responsibility for direct reports

Supervision| Performance not corrected

Same Non Conformity occurs repeatedly

Supervision| Performance not corrected

Rules NOT enforced appropriately

Supervision| Performance not corrected

Lack of supervisory / management job knowledge

Teamwork

The Organization shall ensure good coordination and Teamwork.
Supervision| Teamwork

nadequate Teamwork, inadequate coordination

Supervision| Teamwork

Lack of coordination between team members

Supervision| Teamwork

Work plan not defined to assign responsibilities among team members

Supervision| Teamwork

Work plan with gaps - caused confusion

Supervision| Teamwork

Supervisor not able to build team efforts

Supervision| Teamwork

Job assignments not clear

Supervision| Teamwork

Lack of communication methods

Supervision| Teamwork

Lack of responsibility definition

Supervision| Teamwork

Lack to meet to coordinate and communicate

Supervision| Teamwork

Quality plan not reviewed by Team

Supervision| Teamwork

Lack of knowledge of customer requirements by all members

Leadership

Inadequate actions leading a group of people or an organization.
Supervision| Leadership

Unclear or conflicting reporting relationships

Supervision| Leadership

Unclear or conflicting assignment responsibilities

Supervision| Leadership

Improper or insufficient delegation

Supervision| Leadership

Given inadequate policy, procedures, WI, guidelines

Supervision| Leadership

Inadequate instructions, orientation and/or training

Supervision| Leadership

Lack of supervision/management knowledge

Supervision| Leadership

Inadequate communication of lessons learned

Supervision| Leadership

Inadequate performance measurement and evaluation

Supervision| Leadership

Inadequate or incorrect performance feedback

Training / Risk Assessment

Critical training shall be identified and provided.

No training provided

Critical/Essential training NOT provided.
Training / Risk Assessment| No training provided

Training NOT available

Training / Risk Assessment| No training provided

Employees not aware of the need to follow specific steps

Training / Risk Assessment| No training provided

Decision was made not to train

Training / Risk Assessment| No training provided

New process has been introduced

Training / Risk Assessment| No training provided

Experience was considered a substitute of training

Training / Risk Assessment| No training provided

Competency levels were NOT reviewed

Training / Risk Assessment| No training provided

No learning program / Objective

Training Not available

Critical/Essential training NOT available.
Training / Risk Assessment| Training Not available

Task not analyzed

Training / Risk Assessment| Training Not available

Missed required training

Training / Risk Assessment| Training Not available

Decision was made not to develop training

Training / Risk Assessment| Training Not available

New process has been introduced

Training / Risk Assessment| Training Not available

Experience was considered a substitute of training

Training / Risk Assessment| Training Not available

No Procedure available

Training need not identified

Training and competency levels shall be identified.
Training / Risk Assessment| Training need not identified

Skill and Competency requirements have NOT been identified

Training / Risk Assessment| Training need not identified

Specific duties associated with the job NOT identified

Training / Risk Assessment| Training need not identified

Job Description does not define the skill and competencies required

Training / Risk Assessment| Training need not identified

Assumption was made that training was NOT required

Training / Risk Assessment| Training need not identified

Work requirements have changed, but training needs NOT addressed

Training / Risk Assessment| Training need not identified

Training need has NOT been set for task

No competency evaluation

The Organization shall have a process for review of the competency level.
Training / Risk Assessment| No competency evaluation

Competency evaluation not completed

Training / Risk Assessment| No competency evaluation

No process in place for competency evaluation

Training / Risk Assessment| No competency evaluation

Competency evaluation not done

Training / Risk Assessment| No competency evaluation

Assumption that employee have the appropriate skill level for the task

Training / Risk Assessment| No competency evaluation

Employee moved from one job without evaluation of capabilities

Training / Risk Assessment| No competency evaluation

No time taken for pre-job planning

Training / Risk Assessment| No competency evaluation

Job/Task analysis NOT performed

Training / Risk Assessment| No competency evaluation

Identification of required training NOT done

Training / Risk Assessment| No competency evaluation

Evaluation of skills for tasks NOT done

No follow up training

Evaluate the effectiveness of the training.
Training / Risk Assessment| No follow up training

Effectiveness of training NOT followed

Training / Risk Assessment| No follow up training

Refresher training NOT provided

Training / Risk Assessment| No follow up training

Expectation that the employee was fully competent to perform the task

Training / Risk Assessment| No follow up training

Review of training and skill incomplete

Training / Risk Assessment| No follow up training

Supervisor did NOT follow up level of retention

Training / Risk Assessment| No follow up training

Supervisor did NOT monitor work following the training

Provided Training NOT effective

Training / Risk Assessment| No follow up training

Provided Training NOT updated

Training / Risk Assessment| No follow up training

Newly trained NOT under direct supervision

Risk Assessment /MOC / CP

Failure to identify the Hazard / Risk or the need of an MOC.
Training / Risk Assessment| Risk Assessment / MOC / CP

Failure to identify the Hasard / Risk

Training / Risk Assessment| Risk Assessment / MOC / CP

No Risk Management process

Training / Risk Assessment| Risk Assessment / MOC / CP

No risk Control

Training / Risk Assessment| Risk Assessment / MOC / CP

No MOC process

Training / Risk Assessment| Risk Assessment / MOC / CP

No Contingency Plan

Training / Risk Assessment| Risk Assessment / MOC / CP

RM / MOC / CP processes NOT re-enforced or supported

Training / Risk Assessment| Risk Assessment / MOC / CP

RM / MOC / CP processes NOT well understood

Training / Risk Assessment| Risk Assessment / MOC / CP

RM / MOC / CP processes NOT implemented

Training / Risk Assessment| Risk Assessment / MOC / CP

RM / MOC / CP processes Misused

Problem Identification / Control

Problems must be recorded and reported in order to make sure elimination and recurrence.

Problem reporting

It is critical that all questionable conditions are reported.
Problem Identification / Control| Problem reporting

Personnel do NOT report events that might have impact to Q&HSE

Problem Identification / Control| Problem reporting

Personnel are NOT aware that such events should be reported

Problem Identification / Control| Problem reporting

Employees fear reprisal, punishment, or extra work if they report an incident

Problem Identification / Control| Problem reporting

Reporting culture NOT present

Problem Identification / Control| Problem reporting

Reporting process not understood

Problem Identification / Control| Problem reporting

Reporting training not provided

Problem analysis / identification

Logical and critical process analysis must address root causes to evaluate why a problem occurred.
Problem Identification / Control| Problem analysis / identification

Problem was miss-diagnosed

Problem Identification / Control| Problem analysis / identification

Problem was given little, if any, critical thought

Problem Identification / Control| Problem analysis / identification

Subject Matter Expert (SME) were not included in the problem analysis

Problem Identification / Control| Problem analysis / identification

Problem analysis techniques are NOT understood

Problem Identification / Control| Problem analysis / identification

NO Problem Analysis process in place

Problem Identification / Control| Problem analysis / identification

Data gathering incomplete

Problem Identification / Control| Problem analysis / identification

NO method used for root cause analysis identification

Problem Identification / Control| Problem analysis / identification

Only quick fixes focus on symptoms or short term solutions

Corrective action inadequate

There is a likelihood that the event can recur.
Problem Identification / Control| Corrective action inadequate

Failure to take the corrective action or the corrective action does not address the problem

Problem Identification / Control| Corrective action inadequate

The true root cause was identified, but the actions did not fully addressed the cause

Problem Identification / Control| Corrective action inadequate

The implemented corrective action was unsuccessful in preventing recurrence

Problem Identification / Control| Corrective action inadequate

Additional corrective actions should have been included

Problem Identification / Control| Corrective action inadequate

Corrective actions did NOT focus on related causes

Problem Identification / Control| Corrective action inadequate

Decision was made not to fix the identified root cause

No correction taken

Following a NCR, it is necessary to take the steps for correction.
Problem Identification / Control| No correction taken

It was decided that it was close enough and passes through it

Problem Identification / Control| No correction taken

Components are tested and retested until they pass.

Problem Identification / Control| No correction taken

Decision was made to use it "as is" no qualified personnel involved

Problem Identification / Control| No correction taken

Engineering was not involved in evaluating between MAC and DAC

Problem Identification / Control| No correction taken

Concession request not signed by the client

Problem Identification / Control| No correction taken

Unilateral decisions for manufacturing/design acceptance criteria

Problem Identification / Control| No correction taken

Correction performed but the component was not retested to ensure compliance

Inadequate tools / equipment

Inadequate Quality tools and equipment.
Problem Identification / Control| Inadequate tools / equipment

Inadequate assessment of jobs needs and risks

Problem Identification / Control| Inadequate tools / equipment

Inadequate human factors / ergonomic considerations

Problem Identification / Control| Inadequate tools / equipment

Inadequate standards or specifications

Problem Identification / Control| Inadequate tools / equipment

Inadequate salvage and reclamation

Problem Identification / Control| Inadequate tools / equipment

Inadequate removal and replacement of unsuitable items

Problem Identification / Control| Inadequate tools / equipment

Inadequate retirement / removal / disposition / replacement of unsuitable / deteriorated items

Human Machine Interface

Human - Machine interaction or connect needs improvement.
Problem Identification / Control| Human Machine Interface

Labels need improvement

Problem Identification / Control| Human Machine Interface

Arrangement / placement

Problem Identification / Control| Human Machine Interface

Displays need improvement

Problem Identification / Control| Human Machine Interface

Controls need improvement

Problem Identification / Control| Human Machine Interface

Monitoring Alertness needs improvement

Problem Identification / Control| Human Machine Interface

Plan/unit differences

Problem Identification / Control| Human Machine Interface

Excessive lifting

Problem Identification / Control| Human Machine Interface

Tools / Instruments need improvement

Human Factors

Personal factors, perceptions, influences with adherence behaviors in employees.

Physical Factors

Height, weight, size, strength, reach, etc.
Human Factors| Physical Factors

Restricted range of body movement

Human Factors| Physical Factors

Limited ability to sustain body position (awkward body position)

Human Factors| Physical Factors

Substance sensitivities or allergies

Human Factors| Physical Factors

Sensitivity to sensory extremes (temp, sound)

Human Factors| Physical Factors

Vision deficiency / No direct line of sight

Human Factors| Physical Factors

Hearing deficiency / Noisy work environment

Human Factors| Physical Factors

Slow reaction time

Human Factors| Physical Factors

Respiratory problems

Human Factors| Physical Factors

Other permanent physical disability

Human Factors| Physical Factors

Temporary disability

Mental / Psychological Factors

Memory failure
Human Factors| Mental / Psychological Factors

Fears and phobias

Human Factors| Mental / Psychological Factors

Preoccupation with problems / social or personal issues

Human Factors| Mental / Psychological Factors

Mental Factor

Human Factors| Mental / Psychological Factors

Extreme judgement / decision demands

Human Factors| Mental / Psychological Factors

Routine, monotonous task

Human Factors| Mental / Psychological Factors

Extreme concentration / perception demands

Human Factors| Mental / Psychological Factors

Wrong perception of meaningless or degrading activities

Stress

State of mental or emotional strain or tension resulting from adverse or demanding circumstances.
Human Factors| Stress

Frustration

Human Factors| Stress

Fatigue due to task load or duration

Human Factors| Stress

Lack of rest (Rest period ignored)

Human Factors| Stress

Fatigue due to sensory overload

Human Factors| Stress

Increased exposure to temperature extremes

Human Factors| Stress

Emotional disturbance

Human Factors| Stress

Aggression

Human Factors| Stress

Peer pressure

Knowledge / Skill

Lack the ability to do something correctly or well.
Human Factors| Knowledge / Skill

Lack of experience

Human Factors| Knowledge / Skill

Inadequate orientation

Human Factors| Knowledge / Skill

Employee taking a task that he thought he was competent

Human Factors| Knowledge / Skill

Misunderstood directions

Human Factors| Knowledge / Skill

Lack of situational awareness

Human Factors| Knowledge / Skill

Inadequate review instructions

Human Factors| Knowledge / Skill

Inadequate practice

Human Factors| Knowledge / Skill

Lack of coaching

Human Factors| Knowledge / Skill

Infrequent performance

Improper Motivation / Feedback (Management)

Demotivation or inadequate stimulation to work / perform.
Human Factors| Improper Motivation / Feedback (Management)

Improper performance feedback

Human Factors| Improper Motivation / Feedback (Management)

Proper performance is wrongly corrected

Human Factors| Improper Motivation / Feedback (Management)

Lack of incentives

Human Factors| Improper Motivation / Feedback (Management)

Improper Motivation

Human Factors| Improper Motivation / Feedback (Management)

Aggression / Hostile behavior or attitudes from Management

Human Factors| Improper Motivation / Feedback (Management)

Improper attempt to save time or effort (shortcuts)

Human Factors| Improper Motivation / Feedback (Management)

Improper attempt to avoid discomfort

Human Factors| Improper Motivation / Feedback (Management)

Improper attempt to gain attention

Human Factors| Improper Motivation / Feedback (Management)

Improper leading example

Human Factors| Improper Motivation / Feedback (Management)

Employee feedback needs improvement

Abuse or Misuse

Intentional misuse or abuse.
Human Factors| Abuse or Misuse

Improper conduct

Human Factors| Abuse or Misuse

Intentionally NOT taking proper care while performing a task

Human Factors| Abuse or Misuse

Failure to take reasonable or prudent care

Human Factors| Abuse or Misuse

Intentional misuse or abuse of Company property or equipment

Human Factors| Abuse or Misuse

Intentional attempt to NOT follow directions or procedures

Human Factors| Abuse or Misuse

Substance abuse

Design and Development

All aspects of the design and development process including product and test equipment for parts materials and processes.

Product Design Input / Output

No alignment of the inputs and outputs.
Design and Development| Product Design Input / Output

Design process flawed (failure to include inputs)

Design and Development| Product Design Input / Output

Design output (specifications and drawings) unclear/incomplete

Design and Development| Product Design Input / Output

Inconsistent inputs/outputs

Design and Development| Product Design Input / Output

Design review process failed to detect errors

Design and Development| Product Design Input / Output

Inadequate design, standards, procedures, guidelines

Design and Development| Product Design Input / Output

Inadequate design criteria/specifications

Design and Development| Product Design Input / Output

Inadequate design review

Design and Development| Product Design Input / Output

Inadequate tendering process / bid

Design and Development| Product Design Input / Output

Inadequate contract / pre-contract meetings

Suitability of Test Equipment

Selection, use and application of Test Equipment.

Design and Development| Suitability of Test Equipment

Wrong test equipment for the product

Design and Development| Suitability of Test Equipment

All test requirements were NOT included in the design process

Design and Development| Suitability of Test Equipment

Test equipment NOT available OR hard to mobilize

Design and Development| Suitability of Test Equipment

Test equipment has WITHOUT the ability/range to test the product

Design and Development| Suitability of Test Equipment

Testing personnel not qualified/familiar with testing equipment

Design and Development| Suitability of Test Equipment

Procedures for testing not defined

Design and Development| Suitability of Test Equipment

Inadequate equipment user instructions/manuals

Design and Development| Suitability of Test Equipment

Alternative test methods not developed when needed

Definition of Acceptance Criteria

Acceptance criteria for component materials, supplied parts and the final product.

Design and Development| Definition of Acceptance Criteria

Inadequate Design Acceptance Criteria

Design and Development| Definition of Acceptance Criteria

Acceptance criteria NOT defined

Design and Development| Definition of Acceptance Criteria

Acceptance criteria NOT effectively communicated

Design and Development| Definition of Acceptance Criteria

Acceptance criteria NOT provided

Design and Development| Definition of Acceptance Criteria

Design specifications are set that Manufacturing cannot realistically meet

Design and Development| Definition of Acceptance Criteria

Inadequate customer order information or processing

Design and Development| Definition of Acceptance Criteria

Inadequate identification of needs

Design and Development| Definition of Acceptance Criteria

Inadequate execution of contract

Design and Development| Definition of Acceptance Criteria

Inadequate routine status meetings

Design and Development| Definition of Acceptance Criteria

Inadequate post contract meetings

Verification / Validation Inadequate

Design process/Methods are used (Verification) to build and test model or prototype (Validation).
Design and Development| Verification / Validation Inadequate

From prototype to production without full testing

Design and Development| Verification / Validation Inadequate

No review (Verification/validation) was performed

Design and Development| Verification / Validation Inadequate

Review process NOT Completed by someone independent of the original design person

Design and Development| Verification / Validation Inadequate

Inadequate design qualification/testing

Design and Development| Verification / Validation Inadequate

Inadequate review process

Design and Development| Verification / Validation Inadequate

Inadequate receiving inspection and acceptance

Design Not Linked to Resources

Requirements of designed product cannot be produced with current vendors.
Design and Development| Design Not Linked to Resources

Lack of technical skills for product design

Design and Development| Design Not Linked to Resources

Lack of manufacturing skills for product design

Design and Development| Design Not Linked to Resources

Lack of personnel skills

Design and Development| Design Not Linked to Resources

Product design to be built to tolerance that vendors were not able to meet

Design and Development| Design Not Linked to Resources

Appropriate resources NOT available

Design and Development| Design Not Linked to Resources

Stated Tolerances NOT reasonable

Design and Development| Design Not Linked to Resources

Design process not defined/linked to resources

Design and Development| Design Not Linked to Resources

Inadequate design Commercialization/launch

Design and Development| Design Not Linked to Resources

Inadequate design development

Inadequate Procurement / Purchasing

Issues in the action of obtaining or procuring something / purchasing.

Design and Development| Inadequate Procurement / Purchasing

Inadequate research on materials / equipment

Design and Development| Inadequate Procurement / Purchasing

Inadequate specification on requisition orders

Design and Development| Inadequate Procurement / Purchasing

Inadequate requisition/ordering system

Design and Development| Inadequate Procurement / Purchasing

Inadequate specifications to vendors

Design and Development| Inadequate Procurement / Purchasing

Inadequate communication of data including HSE data

Design and Development| Inadequate Procurement / Purchasing

Inadequate identification of hazardous materials

Identify causes

First cause:
Second cause:
Third cause:
Fourth cause:
Fifth cause: