The Supplier Failure Investigation and Problem Solving Template

Supplier Overview of Johnson & Johnson MD&D
Supplier Quality Standard Operating Procedures
Supplier Responsibilities for Failure Investigations and Problem Solving
Purpose of this SOP
• Establishes the process for failure investigations and
problem solving activities conducted by suppliers
• Applies to CAPAs, nonconformances, SCARs (Supplier
Corrective Action Requests), etc.
• A Supplier Failure Investigation and Problem Solving
Template is provided
Scope of Supplier Failure Investigation SOP
• Begins when a supplier has been notified of an issue
(nonconformance, CAPA, etc.)
• Ends when the supplier has completed all activities agreed
to with MD&D to execute and document the failure
investigation and problem solving associated with an issue
• Links supplier Failure Investigation (FI) and Problem
Solving (PS) activities with the overall MD&D expectations
for Failure Investigation and Problem Solving
Overall MD&D
MD&D Supplier
Supplier FI/PS
Key Definitions
• Correction - Action to eliminate a detected nonconformity. A repair,
modification, adjustment, relabeling, destruction or inspection of a
product or process.
• Corrective Action - Action to eliminate or reduce the cause or effect
of a detected nonconformity or other undesirable situation, in order to
prevent recurrence.
• Preventive Action - Action to eliminate or reduce the cause or effect
of potential nonconformity, defect or other undesirable situation, in
order to prevent occurrence.
Consistent with existing internal MD&D expectations, but now
making sure the definitions are consistently integrated into
supplier failure investigation activities
• Ensure SOP requirements are met (in procedures & by suppliers)
• Notify the supplier of identified issues (nonconformance, CAPAs)
• Complete and document the full failure investigation (incorporating the
supplier response) in the appropriate system
• Conduct and document the supplier failure investigation and problem
solving activities for supplier related issues
• Provide the information and/or template as requested by the MD&D
Operating Company that requested the failure investigation
Key Requirements
• Suppliers to use MD&D form, if specified
―SOP allows for Op Co or supplier forms
―Template provided with the SOP can be used or can act as a guide
―MD&D form has definitions and walks you through the process
• MD&D notification of issues to suppliers
―Requirements for supplier notification are detailed in the SOP
―Timing requirements/deadlines still determined by each Op Co
Supplier Failure Investigation and Problem
Solving Process
• Problem Statement / Supplier notification
• Bounding and containment
―Preliminary cause analysis (rationale for bounding)
• Corrections
• Root cause
• Plan corrective/preventive actions & effectiveness monitoring
• Execute the plan and document actions taken
• Monitor effectiveness
Drives suppliers to approach failure investigation and problem
solving in a similar fashion to J&J MD&D
Problem Statement & Bounding/Containment
• Process starts with a good Problem Statement
―Clearly and factually describe the current condition as compared to
the “should-be” condition
―Measureable (how often, how much, when, where) and fact-based
―Typically provided by MD&D (supplier can update)
• Supplier to conduct bounding and containment
―Locating and segregating suspect/nonconforming material at all
locations (supplier, sub-tiers, alternate sites, etc.)
―Broad based approach identifying product that may be impacted
―Should be based on Preliminary Cause Analysis (PCA provides a
rationale for bounding)
Preliminary Cause Analysis
• Extent of bounding should be based on Preliminary Cause
Analysis (PCA) - provides rationale for bounding
• PCA is essentially the start of root cause identification
• Output of PCA is an understanding of potential causes,
which can be used to establish bounding
Tools, such as 5-Why, should be used
• Corrections: Documented action taken to eliminate and/or
rework, repair, or a contain a detected nonconformity(s) and
to document the final product disposition
• Root cause not required for correction, rather it focuses on
ensuring that the defects in question are properly controlled
• Any new controls/rework should be evaluated for the need
to be verified or validated
• Corrections can have unintended consequences (e.g. removing
burrs can result in foreign matter/contamination)
The SOP and template are intended to aid suppliers in understanding
the differences between Correction and Corrective Action
Root Cause Identification
• Continuation of any Preliminary Cause Analysis activities
• Document the root cause(s) that if corrected prevents reoccurrence of the same event. If root cause not confirmed then
identify probable cause.
• Provide a rationale for root cause selection
―Whenever possible, this can be accomplished by confirming
the selected root cause turns the issue on/off
―Identify and attach tools used, such as 5-Why
• In most cases training or human error is not the root cause
• After root cause identification, ensure bounding is still appropriate
• Identify any controls that were not effective
Planning Corrective and Preventive Actions
• Establish planned corrective and/or preventive actions
― Who, what, when
• Corrective actions prevent recurrences by eliminating causes. Corrective
Action is designed to prevent the recurrence of nonconformities/issues.
• While corrective actions prevent recurrence, preventive actions prevent
occurrence (to prevent the occurrence of situations that do not yet exist)
― Don’t just think of the single part, product, process or plant
• Where applicable, plan to update FMEAs and control plans
• Training should typically not be the only corrective action
• Document an effectiveness monitoring plan if needed (based on
franchise CAPA/NC procedures; see SOP for details)
Additional CA/PA planning details are provided in the SOP
Execute and Document Actions Taken
• Carry out and document actions per established timing
• Notify MD&D of any changes to the plan
• Verify/validate per Op Co procedures
• Provide summary of investigation/activities and evidence
• Monitor/document effectiveness as defined in the plan
―If not effective, continue with the Failure Investigation process
Supplier Failure Investigation and Problem Solving Template
The Supplier Failure Investigation and Problem Solving Template
walks the user through the failure investigation process
Supplier Failure Investigation and Problem Solving Template
The template includes definitions for key terms and can be used as a
process guide even if an alternate form is being used
Supplier Failure Investigation and Problem Solving Template
Planned actions and problem solving progress can be documented in
the Supplier Failure Investigation Template