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
Product/Material requirements NOT met
Data book incomplete (Traceability identification)
Supplier Documentation / Records not completed
Products/Materials failed the inspection process
Insufficient evidence of required tests performed
Vague Quality Requirements (Not clearly stablished)
Visual inspection criteria not met
Outdated Specifications
Lack of participation in Validation
Preservation
Inappropriate Handling / Storage
Shelf life of material and products can be exceeded (EXPIRED)
Unauthorized material substitution affecting the final product
Materials and products damaged
Inadequate or inappropriate equipment used for handling the product
Location for storing NOT appropriate for the product
Inadequate inspection upon receiving the product at location
Mix-up of products due to inadequate tagging system
Packaging / Shipping
Product (Material) not packaged in a prudent and practical manner
Exposure to adverse conditions and/or damaged packaging
Material was damaged during shipping
Packaged not adequate for the product/conditions
Packaged not adequate for the conditions
Inadequate Handling during shipping
No inspection and documentation review in the shipping state
No inspection and documentation review in the shipping state
Product acceptance criteria
Acceptance Criteria NOT Stablished between Company and Vendor
Acceptance criteria NOT adequately communicated to vendor/personnel
Testing procedure and/or related acceptance criteria was not clearly established
Design acceptance criteria not aligned with Manufacture AC
Acceptance Criteria incomplete
Testing procedures not known
Inadequate Identification of needs (Vendors/Customers)
Inadequate contractor selection
Inadequate contract / post contract meeting
Inspection process / Reasonable Expectations
Inspection of materials/products was NOT performed
Inspection of materials was NOT performed in accordance to testing procedures
Product not tested in accordance with the inspection and test plan
Inspection requirements Not implemented
Unacceptable material or product Is not appropriately identified and isolated to
No hold point
Hold point not performed
Inspection Not required
Inspection procedures needs improvement
Component failures a result of "Testing to failure"
Testing / Operating conditions are beyond design criteria
Re-work or multiple re-works
Failure expected in the normal operations
Inadequate Logistics / Delivery
Inadequate package / container
Inadequate papers / documentation
Inadequate customs clearance
Inadequate transportation (mode, availability, standard, specs)
Inadequate storage / warehousing
Inadequate handling / Manipulation
Insufficient / inadequate shipment / goods / load delivery
Engineering/Sales
Capabilities of personnel in the development of design, development and control of systems.
Fault intolerant conditions
Special processes required
Components used in the assembly are not individually marked. Incorrect part
Location where defects occurred were not able to be inspected
Inadequate controls in place
Technicians not attentive to their work
Misplacement
Inspection not recorded
Lack of order, housekeeping due to human factors
Workplace layout
Similar pieces of equipment do not function in similar manner
Equipment have gauges that do not have the required accuracy
No inspection requirements are identified on purchase orders
Labeling schemes not consistent
Equipment used not reliable
Inconsistent layout or operation of test equipment or measurement devices
Difficult to read measuring devices or do not have adequate accuracy
Work Environment (Ambient condition)
Extreme temperature in the workplace - Affect personnel performance or properties of product/material
Low lighting levels - Affects personnel performance
High noise conditions
Lack of ventilation
Work Environment
Housekeeping needs improvement
Obstructions
Equipment guards needs improvement
High contamination
Unrealistic monitoring requirement
Equipment controls are so complex that contributes to failure
Too many variables to monitor
Change of methods for monitoring
Loss of alertness of the employee
Excessive length of time to monitor a task
Complex methods to monitor the task
Too many number of monitoring points (unnecessary)
Excessive data manipulation required
Monitoring issues were not considered in the design process
Complicated logic sequence
Extended amounts of information to memory
Complicated information
Conditions not anticipated by employee
Process for clearing an upset condition was not clearly defined
Inadequate Marketing and Sales
Inadequate understanding of market needs
Inadequate development of client relationships
Inadequate customer satisfaction monitoring
Inadequate knowledge of competitors
Inadequate communications of capabilities / technologies
Inadequate response to service delivery failures / complaints
Inadequate understanding / appreciation of operational capabilities
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.
P/WI/D was NOT available
P/WI/D NOT used/followed
Task performed infrequently
Steps of the process not described in detail
Error in sequence of steps
Steps of the process NOT easily remembered
Inadequate Maintenance of P/WI/D (Tracking, updating, monitoring)
Procedure difficult to use
Procedure use not required but should
No procedure – but should have one
NO Procedure/Work Instruction/Drawing
The need of a P/W/D was NOT identified
Assumption that the process is logical and obvious (wrong)
Process has been introduced and P/W/D was not yet been developed
Inventory and evaluation of exposures and needs
No procedure/practice rules
Inadequate / wrong
P/WI/D NOT adequate / Wrong. Ambiguous instructions
P/WI/D do NOT contain sufficient information
Wrong sequence of steps
The instructions did not adequately describe what actions or information
Set of Steps missing in the P/W/D
P/WI/D difficult to follow
Organization failed to address statutory/regulatory requirements
Scope of P/WI/D NOT well defined
P/WI/D does not refers others P/WI/D that do contain the data
P/WI/D contains inadequate checklist
Confusing
Steps are difficult to follow
Steps do not follow a logical sequence
Instructions can be interpreted in more that one way
Insufficient information (too brief)
Poor quality or misleading P/WI/D
Checklist missing
Format is confusing
Excess of references
Inadequate Monitoring of compliance
Situation not covered
Not revised
P/WI/D have NOT been updated/revised to meet specific customer requirements.
P/WI/D NOT updated to specific customer requirements
Specific Customer requirements not revised/communicated
Specific Customer requirements not communicated
Details of product requirements not changed
Current revised document not created
Common knowledge that a process has changed, NO revised procedure developed
Old versions / Obsolete NOT removed / replaced / destroyed
No MOC applied when necessary
Inadequate sharing of current P/WI/D
New not adequately implemented
Current revised document incomplete
Current revised document incorrect
Management System Tools
Framework of Policies / Stds. including processes and/or Adm. controls.
NO Standards and Policies
MS confusing
MS incomplete
Standards/Policies recently changed
MS ST and Policies not implemented
MS accountability needs improvement
Infrequent Audits & Evaluations
Audits & Evaluations lack of depth
No employee feedback
Communication
Act of exchanging information. Addresses informal methods such as face to face, emails, phone, etc.
Between groups / shifts / locations
Communication is NOT provided in a consistent manner to all departments
Shifts do not adequately communicate critical aspects
Policies and Procedures not effectively communicated to all
Customer requirements not communicated in a timely manner
Employee concerns are not communicated to management
Log book not used to communicate key issues between shifts
No Suggestion box in place for the facility
Changes NOT communicated to all shifts or NOT effectively communicated
Verbal instructions not understood
Inadequate distribution of P/WI/D
With Customer or vendor
Customer requirements NOT communicated
Changes to customer requirements NOT communicated effectively
Changes to customer requirements NOT communicated to vendors
Changes in the vendors ability to meet requirements NOT communicated
Phone calls, emails, etc. NOT answered in a timely manner
Poor communication with suppliers or Vendors
Not having assigned a person responsible to communicate
Misunderstood communications
Oral instructions are given when written instructions should have been provided
The giver and recipient of oral communication NOT "on the same wave length
Slang, abbreviations or similar jargon caused communication breakdown
Standard terminology NOT used NOT understood
Repeat back of instructions NOT used (feedback)
Noisy environment
Language barrier
Incorrect instructions provided
Inadequate matching of individual qualifications and job/task requirements
Wrong instructions
Customer specific requirements NOT communicated
Supervision assume certain "facts"
Revised instructions and procedures NOT communicated
Wrong instructions were provided
Wrong method of communication
Communication not clear/adequate
Personnel turnover
High turnover of personnel changing the work environment
Untrained worker assigned to perform the task due to employee turnover
Unexpected absenteeism can cause a shift in the assignments
Jobs being performed by multiple shifts
Communication between shifts
Rapid growth in the organization
Changes in supervisors
Communications methods
No communication methods or inadequate
Inadequate message length (Too short, too long)
Verification/repeat feedback not used
Speech interference
Inadequate communication due to job turn over
Inadequate communication of safety, health data or regulations
Standard terminology not used
No communication skills/knowledge
Supervision
Supervisors are accountable for adequate Job planning/preparation/Walk through.
Job Planning or Preparation
Inadequate Job Planning/Preparation
Potential problems NOT identified prior to job execution
Assumption that job was understood
Supervisor fails to ensure that all resources are provided
Assumption is made that process have NOT changed
Failure to identify and mitigate Risks
Lack of communication of customer requirements
Inadequate long term planning
Resource Scheduling Problems
Resources shortfall
Work NOT performed when schedule
Product/Parts/Raw Material delivery dates NOT met
Process capabilities could not meet production requirements
Lack of personnel for shift
Timing not met. (Not planned, evaluated and/or coordinated)
Inadequate selection of worker
Worker Selection
Qualified worker for the job NOT selected
Workers assigned NOT competent for task assigned
Insufficient number of trained employees for the task
Employee was expected to perform task without the appropriate training
Credentials of employee performing tasks not verified
Supervisor does NOT have the resources to determine if worker is qualified
Supervisor does NOT qualified to determine worker's competency
New employee issue, expected to perform as experienced employee
Inadequate matching of individual qualifications and job/task requirements
Performance not corrected
Poor performance NOT corrected
NOT properly addressing Non Conformities
Supervision allows improper performance
Supervision ignores systemic conditions
Supervision does NOT take responsibility for direct reports
Same Non Conformity occurs repeatedly
Rules NOT enforced appropriately
Lack of supervisory / management job knowledge
Teamwork
nadequate Teamwork, inadequate coordination
Lack of coordination between team members
Work plan not defined to assign responsibilities among team members
Work plan with gaps - caused confusion
Supervisor not able to build team efforts
Job assignments not clear
Lack of communication methods
Lack of responsibility definition
Lack to meet to coordinate and communicate
Quality plan not reviewed by Team
Lack of knowledge of customer requirements by all members
Leadership
Unclear or conflicting reporting relationships
Unclear or conflicting assignment responsibilities
Improper or insufficient delegation
Given inadequate policy, procedures, WI, guidelines
Inadequate instructions, orientation and/or training
Lack of supervision/management knowledge
Inadequate communication of lessons learned
Inadequate performance measurement and evaluation
Inadequate or incorrect performance feedback
Training / Risk Assessment
Critical training shall be identified and provided.
No training provided
Training NOT available
Employees not aware of the need to follow specific steps
Decision was made not to train
New process has been introduced
Experience was considered a substitute of training
Competency levels were NOT reviewed
No learning program / Objective
Training Not available
Task not analyzed
Missed required training
Decision was made not to develop training
New process has been introduced
Experience was considered a substitute of training
No Procedure available
Training need not identified
Skill and Competency requirements have NOT been identified
Specific duties associated with the job NOT identified
Job Description does not define the skill and competencies required
Assumption was made that training was NOT required
Work requirements have changed, but training needs NOT addressed
Training need has NOT been set for task
No competency evaluation
Competency evaluation not completed
No process in place for competency evaluation
Competency evaluation not done
Assumption that employee have the appropriate skill level for the task
Employee moved from one job without evaluation of capabilities
No time taken for pre-job planning
Job/Task analysis NOT performed
Identification of required training NOT done
Evaluation of skills for tasks NOT done
No follow up training
Effectiveness of training NOT followed
Refresher training NOT provided
Expectation that the employee was fully competent to perform the task
Review of training and skill incomplete
Supervisor did NOT follow up level of retention
Supervisor did NOT monitor work following the training
Provided Training NOT effective
Provided Training NOT updated
Newly trained NOT under direct supervision
Risk Assessment /MOC / CP
Failure to identify the Hasard / Risk
No Risk Management process
No risk Control
No MOC process
No Contingency Plan
RM / MOC / CP processes NOT re-enforced or supported
RM / MOC / CP processes NOT well understood
RM / MOC / CP processes NOT implemented
RM / MOC / CP processes Misused
Problem Identification / Control
Problems must be recorded and reported in order to make sure elimination and recurrence.
Problem reporting
Personnel do NOT report events that might have impact to Q&HSE
Personnel are NOT aware that such events should be reported
Employees fear reprisal, punishment, or extra work if they report an incident
Reporting culture NOT present
Reporting process not understood
Reporting training not provided
Problem analysis / identification
Problem was miss-diagnosed
Problem was given little, if any, critical thought
Subject Matter Expert (SME) were not included in the problem analysis
Problem analysis techniques are NOT understood
NO Problem Analysis process in place
Data gathering incomplete
NO method used for root cause analysis identification
Only quick fixes focus on symptoms or short term solutions
Corrective action inadequate
Failure to take the corrective action or the corrective action does not address the problem
The true root cause was identified, but the actions did not fully addressed the cause
The implemented corrective action was unsuccessful in preventing recurrence
Additional corrective actions should have been included
Corrective actions did NOT focus on related causes
Decision was made not to fix the identified root cause
No correction taken
It was decided that it was close enough and passes through it
Components are tested and retested until they pass.
Decision was made to use it "as is" no qualified personnel involved
Engineering was not involved in evaluating between MAC and DAC
Concession request not signed by the client
Unilateral decisions for manufacturing/design acceptance criteria
Correction performed but the component was not retested to ensure compliance
Inadequate tools / equipment
Inadequate assessment of jobs needs and risks
Inadequate human factors / ergonomic considerations
Inadequate standards or specifications
Inadequate salvage and reclamation
Inadequate removal and replacement of unsuitable items
Inadequate retirement / removal / disposition / replacement of unsuitable / deteriorated items
Human Machine Interface
Labels need improvement
Arrangement / placement
Displays need improvement
Controls need improvement
Monitoring Alertness needs improvement
Plan/unit differences
Excessive lifting
Tools / Instruments need improvement
Human Factors
Personal factors, perceptions, influences with adherence behaviors in employees.
Physical Factors
Restricted range of body movement
Limited ability to sustain body position (awkward body position)
Substance sensitivities or allergies
Sensitivity to sensory extremes (temp, sound)
Vision deficiency / No direct line of sight
Hearing deficiency / Noisy work environment
Slow reaction time
Respiratory problems
Other permanent physical disability
Temporary disability
Mental / Psychological Factors
Fears and phobias
Preoccupation with problems / social or personal issues
Mental Factor
Extreme judgement / decision demands
Routine, monotonous task
Extreme concentration / perception demands
Wrong perception of meaningless or degrading activities
Stress
Frustration
Fatigue due to task load or duration
Lack of rest (Rest period ignored)
Fatigue due to sensory overload
Increased exposure to temperature extremes
Emotional disturbance
Aggression
Peer pressure
Knowledge / Skill
Lack of experience
Inadequate orientation
Employee taking a task that he thought he was competent
Misunderstood directions
Lack of situational awareness
Inadequate review instructions
Inadequate practice
Lack of coaching
Infrequent performance
Improper Motivation / Feedback (Management)
Improper performance feedback
Proper performance is wrongly corrected
Lack of incentives
Improper Motivation
Aggression / Hostile behavior or attitudes from Management
Improper attempt to save time or effort (shortcuts)
Improper attempt to avoid discomfort
Improper attempt to gain attention
Improper leading example
Employee feedback needs improvement
Abuse or Misuse
Improper conduct
Intentionally NOT taking proper care while performing a task
Failure to take reasonable or prudent care
Intentional misuse or abuse of Company property or equipment
Intentional attempt to NOT follow directions or procedures
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
Design process flawed (failure to include inputs)
Design output (specifications and drawings) unclear/incomplete
Inconsistent inputs/outputs
Design review process failed to detect errors
Inadequate design, standards, procedures, guidelines
Inadequate design criteria/specifications
Inadequate design review
Inadequate tendering process / bid
Inadequate contract / pre-contract meetings
Suitability of Test Equipment
Selection, use and application of Test Equipment.
Wrong test equipment for the product
All test requirements were NOT included in the design process
Test equipment NOT available OR hard to mobilize
Test equipment has WITHOUT the ability/range to test the product
Testing personnel not qualified/familiar with testing equipment
Procedures for testing not defined
Inadequate equipment user instructions/manuals
Alternative test methods not developed when needed
Definition of Acceptance Criteria
Acceptance criteria for component materials, supplied parts and the final product.
Inadequate Design Acceptance Criteria
Acceptance criteria NOT defined
Acceptance criteria NOT effectively communicated
Acceptance criteria NOT provided
Design specifications are set that Manufacturing cannot realistically meet
Inadequate customer order information or processing
Inadequate identification of needs
Inadequate execution of contract
Inadequate routine status meetings
Inadequate post contract meetings
Verification / Validation Inadequate
From prototype to production without full testing
No review (Verification/validation) was performed
Review process NOT Completed by someone independent of the original design person
Inadequate design qualification/testing
Inadequate review process
Inadequate receiving inspection and acceptance
Design Not Linked to Resources
Lack of technical skills for product design
Lack of manufacturing skills for product design
Lack of personnel skills
Product design to be built to tolerance that vendors were not able to meet
Appropriate resources NOT available
Stated Tolerances NOT reasonable
Design process not defined/linked to resources
Inadequate design Commercialization/launch
Inadequate design development
Inadequate Procurement / Purchasing
Issues in the action of obtaining or procuring something / purchasing.
Inadequate research on materials / equipment
Inadequate specification on requisition orders
Inadequate requisition/ordering system
Inadequate specifications to vendors
Inadequate communication of data including HSE data
Inadequate identification of hazardous materials
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