PROBLEM SOLVING PROCESS

QMS SOP, WI FRM

STEP ACTIONS RESPONSIBILITY References Links to supporting documentation

Verify Problem is real

Problem Statement: What is wrong with what; object, defect; in terms of
observable condition; not a solution or cause or desired change.
Goal not met, requirement not met, error or error code, specification
failed, observed functional failure

First Pass Extent of Problem: occurrence/failure/defect rate?, number of

affected Customers? Affected Products, Affected unit quantity? Affected
parts/subassemblies/components in WIP, Finished Goods, Distributor,
Supplier, transit
Excursion Risk Assessment form
SQE Material at Risk procedure
if found in IQA Guid-PD-011 Measurement System Validation
First Pass Containment Action: Engineer on Duty
Material potentially escaped to field? Escalate to Senior Mgmt & QA if found in mfg/service
immediately
Situation Analysis
Triage Stop Shipment?, Stop Production? Product Support Engineer
0 First Aid Quarantine affected material, DR/QNote and notify Senior management & if found in Field
Prepare QA immediately
Plan If recommending shipment of known defective/nonconforming material a Chronic
risk assessement must be approved by QA and the TRB (Final decision lies Commodity Manager, Auditor, QA,
with the PMT/PSRB & LOB/QA) Supervisor, Manager
DEFINE

Any screening and/or rework process?

MSA on screen, rework effective? TRB approval on screening pDR Governing Bodies
Gather known data and facts about the Problem, baseline performance: QA, Regulatory, TRB
time series trend (chronic or new) PMT or PSRB
Any patterns? apparent change point, Is, Is Not (where/when is the
Problem occuring and where/when could it be occuring but its not)
Objective evidence for Problem, video, pictures, assy-dissy (suspect
component), post hoc analysis (Suspect Characteristic or feature), material
lot, vintage, supplier customer or geographic associations Is, Is Not Form
Gather first diagnostic pairs: examples of good and bad parts,
components, material, events (documentation)

Management reviews data and assigns resources & priority

Small crossfunctional problem solving team
Determine time allotment of team
Determine logistical team if Problem is an excursion
Determine technical & management oversight team(s)
1 Form Team Determine frequency and venue for technical & management review Leadership Team
Who will be the point person for communication
RACI

Understand the Problem

Verify that Problem is real (MSA?, real specs)
5W,2H; Is, Is Not
Verify/Complete Extent of Problem: occurrence/failure/defect rate?,
number of Affected Customers? Affected Products, Affected unit
quantity? Affected parts/subassemblies/components in WIP, Finished
2 Problem Description Goods, Distributor, Supplier, transit Team Is, Is Not Form
If functional failure or error code, what is happening to create failure? Update Oversight Team

Risk assessment of escaped product @Customer,

MEASURE

If recommending shipment of known defective/nonconforming material,

risk assessement approved by QA and LOB (PMT or PSRB)
Material at Risk? Notify regulators as appliable
Stop Shipment?, Stop Production? Quarantine affected material
Any screening and/or rework process? Team
Statistical Sampling plan (RQL/AQL) Update Oversight Team
Material at Risk form
3 Containment MSA on screen, rework effective? DRB Risk Assessment
Field actions to manage Problem: Free Goods, Customer mitigation TRB
QA

Define The Y Team

Establish
4a Measurement System
MSA: Youden or nested Update Oversight Team
DRB
Understand current state and compare good and bad examples: Current
State Map, Function Diagram, Process Map, Force Diagram
5-Whys, Y-X; Functional Decomposition, Apollo method, Is-Is Not, as
applicable
Statistically Designed Studies
4b Identify Causal
ANALYZE

Mechanism Reassess containment actions Team

Update Oversight Team
DRB

4c Identify the Escape Process Map, 5-Why, MSA

Mechanism Reassess containment screens

Elimination of 8 wastes, Five rules in use, future state map, DoE, Team
5a Identify Solutions for characterize operating range, margin tolerance stackups Update Oversight Team
Cause and Escape Revise specifications, Revise Design to eliminate cause, control or DRB
counteract causal mechanism, feedforward or feedback control
Improved Acceptance Sampling, error proofing, In-line SPC
Turn it on & off PS-003
Change Assessment & TRB Approval Change Assessment Form
Do No Harm testing @ system level with Customer use conditions Validation test Plan
Validation Test Results
IQ, OQ GUID-PD-011
FAI Team
Verify & Validate the
5b Solution MSAs for new controls/inspections/error proofing TRB
Results of validation approved by TRB QA
Reassess containment
IMPROVE

Team
Implement the
6a Solution Implementation plan: milestones and timeline, material runout; Update Oversight Team
procurement changes; drawing, IR, WI, SOP changes;training; Capital; SQE, Buyer, Planner, Commodity Mgr
supplier selection
PQ, Results approved by TRB
Baseline comparison before & after Team
6b Validate that the
Update Oversight Team
TRB
solution corrected the QA
Problem
Field Actions? Recall, Point of service or point of failure repair
WIP/NCP: return to supplier or rework inhouse (Warranty coverage?) Team
Scrap? Oversight Team/Leadership
6c Remediate the SQE
Problem
QA

Implement Controls to New inspections - Acceptance sampling Team

6d prevent & detect SPC Update Oversight Team
recurrence Field Monitor TRB
Error Proofing
CONTROL

Systemic actions to Other parts susceptable to this causal mechanism or escape cause? Leadership Team
7 prevent occurrence QMS system improvements? Change control, V&V, Calibration, MSA, Team
elsewhere QA
Inspection/Test development, Visual Workplace, SPC...
Lessons Learned - improve problem solving process
8 Close & Congratulate Reward & recognition - celebrate Leadership
the team
Document project

1 of 3 Saved: 04/10/2024
 IDEXX 8D Steps

Situation Analysis to enable prioritization

- Verify Problem is Real
- Problem Statement
0
DEFINE - Extent
- Severity
- First Pass Containment

1 Prioritize and Form Team

2 Problem Description
Containment: quarantine, screening, rework, field
MEASURE 3 compensation
Statistical Sampling plans (RQL/AQL)
4a Establish Measurement System
4b Identify Causal Mechanism
ANALYZE
4c Identify the Escape Mechanism
5a Identify Solutions for Cause and Escape
5b Verify & Validate the Solution
IMPROVE 6a Implement the Solution
6b Validate that the solution corrected the Problem
6c Remediate the Problem
6d Implement Controls to prevent & detect recurrence
Systemic actions to prevent occurrence elsewhere;
7
QMS Changes
CONTROL
Lessons Learned: Improve 8D Process
8 Close & Congratulate the team
Finalize Project Documention
 SPLIT TACTICS
(within piece), piece to piece, lot to lot, material
lot to lot, time to time
Usage: during use, use to use
TEMPORAL
operator to operator
Within a process, step to step, operation to
operation

Location: within piece, cavity to cavity, station

to station, line to line, plant to plant, region to
region, clinic to clinic

STRUCTURAL
Components: sub-assemblies, components,
raw materials, software, algorithm, process by
which the components are 'assembled'
Specific Features, dimensions, properties
Failure modes: complete, partial, intermittant,
unexpected

FUNCTIONAL Use case: user, consumables,

instrument/device, supplies, sample,
environment, conditions
specific functions and energy transfers

What's wrong
What's changed
What's different
What's happening