Quality System Work Instruction
10-10-1001: QCS – Corrective & Preventive Action Process
rev-10a00 - Approved by: Quality Assurance, Operations
1.0 Purpose and Scope
The purpose of this work instruction is to define the formal process of corrective and preventive
actions associated with products, processes, and equipment.
This document pertains to all departments whose activities have an impact on the company’s
quality program.
1.1 Definitions
C&P Action: Corrective and Preventive Action Case managed within QCS system
CAP – Corrective Action Plan: An implementation plan created from the analysis of a problem and
selection of the best solution. Plan may address a “quick-fix” to address immediate problem and/or a
more detailed “root-cause” study, with a resolution to prevent reoccurrence of problem.
CAM – Corrective Action Management Team: Permanent members assigned by the Company and
include a Chairman from Quality, plus department leads from R&D, Quality, Operations, and
Maintenance.
CAT – Corrective Action Team: Team assigned to work a Corrective Action Case
MRT – Management Review Team as defined by the company’s quality program.
Priority High – Safety, Quality Concern (defective product, unusable production equipment)
Priority Medium – Productivity, Value Added (Time or Dollar savings)
Priority Low – Not system critical, low time or money savings.
QCS – Quality Compliance System: Online system to manage and report quality compliance
1.2 Discussion
Distinction between a corrective and preventive action is that a corrective action deals with
actual nonconformities and a preventive action deals with a potential nonconformity. The
procedure for handling both types of actions is the same. Therefore, this document does not
distinguish between the two types and refers to both as corrective actions.
The company’s Executive Sponsor appoints & empowers a Corrective Action Team.
Permanent members include a) Chairman from Quality, and b) Department Leads from key
functional areas, such as R&D, Quality, Operations, and Maintenance. The Corrective Action
Team assigns temporary members on a case-by-case basis, selecting individuals with
expertise on the problem or solution of any individual case.
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Quality System Work Instruction
10-10-1001: QCS – Corrective & Preventive Action Process
rev-10a00 - Approved by: Quality Assurance, Operations
2.0 Work Instructions
10.0 Corrective & Preventative Action Process
for Product, Process, and Equipment
Initiate
Initiate
Open
Open
Closed
Closed
6
CAM
Managed
Closure
&
Reporting
Quality History,
Status & Trends
Customer Complaint
reject
Supplier Problems
Detected Problems
Manage
per Schedule
1
2
new
C&P
action
Anyone
Identify
Problem
Suggested
Improvements
Improvement
Projects
3
CAT
CAM
approved
Root
plan
Rank
Cause
--&
with
Assign
resources Corrective
Schedule
Action
Plan
authority
to Work
Group
Related
Actions
Manage
per Schedule
4
5
CAT
Implement
Implement complete
--per
approved
scope
CAM: Corrective Action Managers
CAT: Corrective Action Team members
Out
Brief
CAT
(auditor)
Audit
Results
effectiveness
Follow-up
Actions
(is-req’d)
10-88-1001-09b01
STEP
RESPONSIBILITY
ACTION
Identify Problem
problem or preventive action identified
1
Anyone
a) Enter Required Information
- Using QCS, select 10. Corrective & Preventive Actions / New Tab
- Enter required information within section “Problem Identification”
- Title: descriptive
- Problem-description: may include suggested improvements
- Affected-Area: company defined picklist
- Type: product, process, or equipment
- Reason: internal problem, internal preventive, customer complaint
- Priority of initiator: HIGH(expedite), Med, low, or blank(tbd)
- Status: Problem Identification
b) Add Attachments for added clarification ( if any)
c) Save
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Quality System Work Instruction
10-10-1001: QCS – Corrective & Preventive Action Process
rev-10a00 - Approved by: Quality Assurance, Operations
STEP
RESPONSIBILITY
ACTION
Rank, Assign, Schedule
Scheduling of Open C&P Actions
a) Rank C&P Actions (status “Problem Identifications”)
- Using QCS, select 10. Corrective & Preventive Actions / Open Tab
- Select & review individual OPEN C&P Actions
- Clarify & Update ‘problem identification’ data, contact initiator if req’d
- Determine Severity / set priority
o High, Medium, Low
- Per definitions above
- Go To 02b
o
Reject: No Action To Be Taken
- Enter reason-for-rejection – field “Action Taken”
- Set status to “reject”
- Notify Initiator by email
- Go To Step-06
o
Others:
- Blank (unranked backlog)
- Go To 02b
CAM
2
Corrective
Action
Management
Team
b) Schedule C&P Actions to-be-worked
- Select 10. Corrective & Preventive Actions / Open Tab
- Review ranked C&P Actions
- Select C&P Action determined “ready-to-work”
- Set Status to “Planning”
- Update Corrective Action Plan (CAP) section;
o identify CAP Leader, CAT, Completion Date, …
- Commit resources (people, funds) to support plan
c) Notify CAP Leader & CAT (if assigned) by email
note: the CAP Leader may request additional CAT member where
expertise of problem and/or resolution is required
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Quality System Work Instruction
10-10-1001: QCS – Corrective & Preventive Action Process
rev-10a00 - Approved by: Quality Assurance, Operations
STEP
RESPONSIBILITY
ACTION
Planning
Root Cause & Corrective Action Plan
a) Review Assignments & Current Information
- Using QCS, select 10. Corrective & Preventive Actions / Open Tab
- Select assigned “planning” C&P Action
- Review assignments, schedule, attachments & CAT findings
b) Problem Analysis
o Redefine Problem
- Reviews “knowns”
- Clarify Problem to be worked & document in QCS,
field Problem Analysis ( section “Establish Corrective Action Plan”)
o Determine “Root-Cause”
- Goal: Eliminate Reoccurrence of Problem, Not patch symptom
- Drill to determine multiple suspect causes
- Review know data, to narrow list of causes
- Identify additional data required to further narrow list
- Gather additional data & analyze (repeat above if more data req’d)
- Identify “Root Cause” / document in QCS/ field Root Cause,
( section “Establish Corrective Action Plan”)
CAT
3
Correct Action
Team
hints:
- typically multiple meetings
- look at product, equipment, process, and people
- more complex problems can require longer analysis cycle
- expand team to include required skills & knowledge
- look for similar corrective actions, possible shared resolution
c) Recommend Actions
- Determine one or more C&P Actions
o Changes to process
o Changes to equipment
o Changes to written work instructions
o Goal: prevent recurrence, else earlier detection & correction
- document in QCS/ field Recommended Actions,
( section “Establish Corrective Action Plan” )
d) Present to CAM for approval
- Present Recommended Actions & Reasons Why
- CAM accepts or requests changes to recommended actions
o If adjustments - Go To 02c (or 02b)
o If approved, CAM identifies implementation schedule
- CAT updates QCS to complete plan
- Update schedule dates (section “Establish Corrective Action Plan”)
- Set Status to “Implement” ( section “Problem Identification”)
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Quality System Work Instruction
10-10-1001: QCS – Corrective & Preventive Action Process
rev-10a00 - Approved by: Quality Assurance, Operations
STEP
RESPONSIBILITY
ACTION
Implementation
CAT
4
Correct Action
Team
a) Implement C&P Action as defined in QCS
b) Document Progress:
Update section “CAP Implementation”
- field: Corrective Action Taken
- field: Actual Implementation (completion date)
- attachments: as req’d
- field: Status – promote to “In-Audit” on completion
Audit Results
scheduled after implementation,
when effectiveness of actions can be reviewed.
AUDITOR
5
Typically
From
Corrective
Action Team
a) Audit – perform review of actions taken to determine if actions where
effective, and if root-cause of problem has been addressed.
b) Document Results: update Section “Audit Results”
- field: Audit performed by, actual audit date
- field: Root-cause eliminated (y/n), Audit Results & Recommendations
- attachments: as req’d (supporting documents, data, analysis…)
c) On Completion / Notify CAM
Managed Closure & Reporting
a) Manage Open C&P Action Schedule
- monitor & respond to near-delinquent & late actions
CAM
6
Correct Action
Management
b) Review Audit Results to Close C&P Actions
- if Root Cause not eliminated
then initiate additional C&P Actions, ref parent C&P Action in description
c) Close C&P Action Case
– set Status to “Complete”
d) Standard QCS Compliance Reporting to support
- day-to-day managed progress
- management reviews
- internal & external audits
- trend reporting
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Quality System Work Instruction
10-10-1001: QCS – Corrective & Preventive Action Process
rev-10a00 - Approved by: Quality Assurance, Operations
3.0 References
3.1 Normative References - The following reference contains provisions which through reference
in this text, constitutes provisions of this document. References, which are subject to revision,
should always be used in the most recent form.
QSP 10.1 Corrective and Preventive Actions
3.2 Informative References - The following references are included as bibliographic information,
which may contain material useful for execution of this document. References, which are
subject to revision, should always be used in the most recent form.
QSP
QSP
QSP
QSP
QSP
QSP
QSP
01.1 Management Review Meetings
03.1 Internal Quality Audits
05.1 Control of Quality Records
06.1 Process Control
07.1 ID and Traceability
08.1 Inspection and Testing
09.1 Control of Nonconformance
WI 10-10-0001 QCS – Access to Online Compliance System
WI 10-10-0101 QCS – Management Review
WI 10-10-0301 QCS – Internal Audit Process
WI 10-10-0901 QCS – Nonconforming Process
3.3 Documentation/Records - The implementation of this document requires the use of the
below listed forms or reasonable facsimiles thereof and may result in records as so indicated
in addition to retained completed forms. References, which are subject to revision, should
always be used in the most recent form.
QCS – Quality Compliance System
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