Supplier Overview of Johnson & Johnson - PowerPoint Presentation

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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

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Overall MD&D FI/PS Expectations

MD&D Supplier FI/PS SOP

Supplier FI/PS Activities

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.

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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&DEnsure 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 issuesProvide 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 specifiedSOP allows for Op Co or supplier formsTemplate 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 Co6

Supplier Failure Investigation and Problem Solving Process

Problem Statement / Supplier notification

Bounding and containmentPreliminary cause analysis (rationale for bounding)Corrections

Root cause

Plan corrective/preventive actions & effectiveness monitoring

Execute the plan and document actions taken

Monitor effectiveness

7Drives 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” conditionMeasureable (how often, how much, when, where) and fact-basedTypically 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)8

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 identificationOutput of PCA is an understanding of potential causes, which can be used to establish bounding

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Tools, such as 5-Why, should be used

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 controlledAny 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)

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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 re-occurrence of the same event. If root cause not confirmed then identify probable cause.Provide a rationale for root cause selectionWhenever 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, whenCorrective 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)

12Additional 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

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The Supplier Failure Investigation and Problem Solving Template walks the user through the failure investigation process

Supplier Failure Investigation and Problem Solving Template

Supplier Failure Investigation and Problem Solving Template

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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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Planned actions and problem solving progress can be documented in the Supplier Failure Investigation Template

Supplier Failure Investigation and Problem Solving Template