Supplier Overview of Johnson & Johnson MD&D
Supplier Quality Standard Operating Procedures
(SOPs)
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
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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
FI/PS
Expectations
MD&D Supplier
FI/PS SOP
Supplier FI/PS
Activities
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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
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Responsibilities
MD&D
• 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
Suppliers
• 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
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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
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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
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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)
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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
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Corrections
• 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
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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
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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
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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
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Supplier Failure Investigation and Problem Solving Template
The Supplier Failure Investigation and Problem Solving Template
walks the user through the failure investigation process
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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
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Supplier Failure Investigation and Problem Solving Template
Planned actions and problem solving progress can be documented in
the Supplier Failure Investigation Template
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