Control Phase

Introduction
Major objectives of the Control Phase are:
1. To confirm that the changes have brought about the desired
improvements in process performance,
2. To ensure that the changes continue to have the desired
impact on the process, and
3. To determine whether to close the project, or to ‘loop back’
to an earlier phase within the DMAIC process until the desired
level of improvement has been achieved.

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The major work to be considered in
control Phase
 Process Implementation Plan
 Transition
 Process control Plan
 Process audits
 Major elements of Process Implementation Plan
 Identification of areas(scope) of implementation
 Creation of process support team
 Identify the Point of contact for each area (Business unit)
 Creation of Training Plan and implementation
 Rollout sequence of the process to be implemented
 Identifying the barriers to implementation and devise mechanisms to handle them
 Implementing the processes
 Collecting the suggestions for process improvements
 Making required changes to processes and release of new processes
 Planning the review meeting(s) with the key stakeholders
 Audit plan
 Metrics collection plan and analysis
 Validation check to understand if the objectives are achieved
 Implementation plan – ex for an activity
The log of activities for Implementation for a specific activity/process

Log of activity
Major Activity Objective of Activity Subtask Responsibility Start End Duration Comments/Notes

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Transition Plan
 Creation of the transition plan
 Arrange for the Knowledge sharing sessions
 Identify the deliverables to be transferred and handover them to the
respective team
 Share the lessons learnt with the team
 Share the best practices
 Create the plan for audits, control plan
 Create the hand over-takeover document and got it signed by the
stakeholders
 Submit the documentation to the management
 Dissolve the six sigma team
Deliverables
 Process Implementation Plan and Process implementation results
 Audit plans, audit results for at least for one cycle
 Updated FMEA, process control plans, and standard operating procedures
 Validated capable measurement system(s)
 Production process in statistical control and capable to get as close to Six
Sigma levels as is optimally achievable, at minimum accomplishing the
project goal
 Transition – signed and approved handover take over document
 Updated project documentation, final project reports, and periodic audits
to monitor success and hold the gains
 Control Phase Activities - example
Control Phase Implementation Plan
Major Activity Objective of Activity Subtask Responsibility Due Date Comments/Notes
Deploy revised Error Provide tool for associates Continue to train users in Tonoy Battacharya See Comment for Legal Entity
Ongoing
Correction App to correct part/insp errors Legal Entities Kevin Mitchell assignments
Review Daily Error Deploy Legal Entity Dependent on Error Correction
Identify new/recurring errors Tonoy Battacharya Ongoing
Reports specific reports via email Application training.
Work with Legal Entities to Tonoy Battacharya See Comment for Legal Entity
Ongoing
identify/correct errors Kevin Mitchell assignments
Occurs once sales data for all
Monthly reporting of Legal Entities within scope of
Generate monthly KPI data Retrieve overall error rate Tonoy Battacharya Monthly
Product Errors project has been loaded into Data
Warehouse
Occurs once sales data for all
Retrieve overall Legal Legal Entities within scope of
Tonoy Battacharya Monthly
Entity error status project has been loaded into Data
Warehouse
Occurs once sales data for all
Legal Entities within scope of
Send data to K. Christ Tonoy Battacharya Monthly
project has been loaded into Data
Warehouse

Create Control Chart Kathy Christ Monthly

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Publish metrics Rich Hattery Monthly
 What is Process Control?
 Process controls are methods for assuring that improvements
will be sustained once process changes have been
implemented.
 Process controls can also be used for any process to ensure
that the process continues to perform at the desired level.
 During the Control Phase, Process Control Plan should be
developed for each operation or operation step that is critical
to maintaining the improvements that have been made.
 What is a Process Control Plan?
A control plan is essentially a summary of the types of process
controls that will be used to monitor and control critical process
characteristics. 9
 when to use process controls
Process controls are typically used under the following conditions:
 When critical process characteristics are highly variable.
Process control plans should be prepared for each of these
elements.
 At points in the process where products move across changes in
jurisdiction.
For example, when products move from one department to
another, to and/or from outside suppliers, etc.
 Before embarking on an irreversible path (before the point of no
return).
 After the creation of critical quality characteristics. 10
Process Controls - examples
• System controls and automated controls,
• Monitoring the process via SPC,
• Inspection and test procedures at critical control points,
• In-line ‘go/no-go’ checks,
• Preventive maintenance,
• Scheduled review of SOPs,
• Operator certification and re-certification, and
• Process audits.
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 Process Control Plan - Elements
 The type of process control implemented is based on a number of
considerations, which are built into the control plan:
• What will be monitored: What process characteristics? What
variables are critical to process performance?
• Where to monitor: At what point in the process is it best to
monitor key characteristics?
• The type of data: What types of measurements should be
taken, or can be taken, on the key process characteristics?
• Who: Who will be responsible for monitoring the characteristic
(for taking the measurements)?
• The frequency: How often is the process characteristic 12
measured or checked?
 Process Control Plans - Elements
Control plans generally consist of the following information:
 The operation or process step,
 A list of critical characteristics being monitored at the
operation,
 The measurement or review method and the individual(s)
responsible for measuring each characteristic,
 The measurement or review frequency,
 The type of control used to monitor the characteristic,
 The feedback signal, and
 The corrective action and the individual(s) responsible for 13
acting.
 Process Control Plans - example
The following is a partial process control plan for an OD Grind
operation.
Process Control Plan
Measurement Type of Corrective
Operation Characteristic Responsible Frequency Signal Responsibility
Method Control Action
Control
OD Grind OD Size OD Slide Gage Operator 1 PC/15 min Limits/SPC Adjust Operator
Control
OD Taper OD Slide Gage Operator 1 PC/15 min Limits/SPC Adjust Operator
Control
Off Square OD Slide Gage Operator 1 PC/15 min Limits/SPC Adjust Operator
Surface Finish
Measuring 2 PCs/Twice
Surface Finish Instrument Inspector per Shift Inspection Notify Supervisor Inspector
Computerized 2 PCs/Twice
Profile Profile Gage Inspector per Shift Inspection Adjust Operator

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Process Control Plans – feedback signals/triggers
 Feedback signals, which indicate if the process is not likely to
be performing at the desired level, are critical components of
control plans.
 Typical feedback signals consist of the following activities:
• Data on the key process characteristic(s) is recorded,
• The data is processed or summarized, and
• The data is compared to goals or standards.
 These activities can use highly technical methods or devices, or
can be simple, manual checks.
However, the degree of precision and accuracy required are
important considerations when establishing a feedback signal.
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 Process Control Plans
 As a rule, the more critical the characteristic, the greater the
precision and accuracy required in the measurements.
 Feedback signals trigger corrective actions.
 Process control plans must include actions that need to be
taken if problems appear, and specific instructions for each
of the actions.
 ‘Problems’ can mean that performance is not in line with
goals or standards, or that the process is out of ‘control’.
 The plan must also identify the individuals responsible for
taking the steps necessary to bring the process back to the
desired level of performance or back into control. 16
Audits
Why Audits
Verify processes
Assess successfulness of process implementation
Judge effectiveness of target levels
Reduce and eliminate problem areas
Report non-conformance and corrections
Report good practices
Enable continual improvement
Types of Audits
 Internal Audits
 Performed by trained employee
 External Audits
 Independent audit organization
 Certification
 The Internal Audit process
 Define the objective/purpose/focus of the audit
 Define the scope of the audit
 Scheduling of Audits
 Defining Roles and responsibilities during audits
 Designing the audit checklists(optional)
 Conducting the audit
 Reporting results in a timely manner
 Corrective Action and Verification
 Maintenance of records
Internal Audit (Continued)
During the audit:
 Maintain control
 Ask good questions and focus on interview
 Record observations
 Follow up
Additional Things to Remember During Audit

 Don’t be biased
 Keep an open mind
 Be patient
 Remember that the audit is for continuous
improvement
 Always state the facts
 Report accurately and clearly
Major External Audits (types)
Documented Quality System Audit
Onsite audit of QMS
Certification Audit
Sample of business processes
Continual Certification Audits
After certification
Ensure continued implementation
Audit results - Writing Clear and Concise
Non-conformances (NCs)

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Types of Non conformity

Major Non conformity

Minor Non Conformity
Observation
 Major Non conformity
 A deficiency that seriously impairs the system effectiveness
 The absence or total breakdown of a system to meet the ISO 9000/Process
requirement.
 A bunch of number of minor nonconformities against one requirement can
represent a total breakdown of the system and thus be considered a major
nonconformity.
 Any noncompliance that would result in the probable shipment of
nonconforming product to the customer.
 A condition that may result in the failure or materially reduce the usability of
the products or services for their intended purpose at customer place
 Anything that can affect the quality system itself
Minor Non Conformity

 A minor deficiency that does not seriously impair the

effectiveness of the system

 Examples:
 few individuals (out or many) do not use a procedure correctly
 Procedure needs minor changes to be effective
 One of a few records incomplete
Observation
 Any possible event that is likely to become a non conformance if
not taken care of- essentially an OPINION.

 Examples :
 One person may not follow the procedure out of many
 One or two record may be incomplete or not done
 Not collating the best practices or lessons learnt and ploughing them
back in to the system
Components of writing Non conformances

 Writing Non-conformances (NC) Analysis.

 Parts of a Non Conformance.
 Making it clear.

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Some comments on reported Non-conformances

THE CLIENT SAYS:

 I DON’T HAVE A CLUE WHAT YOU ARE SAYING OR WHAT YOU

ARE TALKING ABOUT……???
 WHY IS THIS AN NC?
 WHAT REQUIREMENT IS VIOLATED?

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 NC Writing Analysis
Following are some of the weaknesses observed during the audits
from the industry perspective.
 The NC as written was “incident specific” and did not address the
systematic issue (s).
 The NC as written could not be understood by the organization
after the audit was completed; and not understandable at later
date.
 The NC did not identify the actual requirement being offended.
 The NC did not identify the supporting objective evidence.
 Poor CA and root cause analysis accepted by the auditor.
 No indication that corrective actions were verified at NC closure.

.
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Writing Process for Non-conformances

 NCs must be clearly written.

 Should address the process/system which is deficient.
 Objective evidence gathered should identify which process is
deficient.
 What is the process?
You must understand the process to verify conformance or
non-conformance.
 Is the non-conformance identified, systemic to the process?

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HOW DEEP SHOULD YOU GO!----INTO THE PROCESS

Evaluate the process thoroughly.

Ensure objective evidence supports conformance or non-
conformance of the process.
Gather enough objective evidence to support your final decision.
Adequate “sampling” of objective evidence.
Repeatability of objective evidence which indicates the
process is not working.
indication of consistent process failure.

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Three Distinct Parts of An NC
An audit NC should have three distinct parts:
 A clear statement of the non-conformance.
 The requirement, or specific reference to the requirement.
If you cannot identify a requirement, then you cannot raise
a non-conformance.
 And finally, objective evidence that supports the statement of
non-conformance; based on the requirement.

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 Making it Clear
 Changing the structure and the way the NC is written can assist
in getting the auditee to address the “root cause” of why the
calibrated equipment is past due calibration.
 The NC must highlight the issue that there is a system/process
failure vs a single incident failure.
 Thus, the corrective action and root cause should be focused
towards system/process failure, not the observed incident.

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 Raising NCR’s
1. Copy from the process,
procedure, form, template
or other document, the
instruction as to what needs
to be done
2. State what is wrong and
how it doesn’t match what
is required
3. If you cannot find the
written requirement, ask
yourself if this is really a non-
conformance?
Activity:
Copy from one of these
 Parts 2 & 3
Fix the problem
• Complete the form
correctly
• Sign the form
• Re-draw the As-built
• Close the scheme Enter a realistic date Decide who the correct person is and speak to him/her
• Provide the missing
document
Ask the 5 why questions
• Why didn’t he do it? Enter the root cause after answering all these questions
• Why didn’t he know he was
supposed to do it
Having worked out the root cause, the action to prevent recurrence is obvious
• Why wasn’t he trained
• Why wasn’t the
Decide who the correct person is and speak to him/her
requirement specified Enter a realistic date

• Why wasn’t there enough

resource to do the work
N.B. The
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Owner should Points
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37
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Examples of POOR NC Statements

 Example: Two pieces of calibrated equipment was past due calibration.

(THIS GIVES ONLY A BRIEF INDICATION OF THE PROBLEM)

AND ALSO
 The statement does not give the auditee any indication that there is a
system/process failure.
 It appears as a single instance.
 It does not identify the actual requirement being offended-actually, it
incorrectly states the requirement.
 As written, the auditee could easily assume the NC was a single incident and
take action ONLY related to the two pieces of calibrated equipment.

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 Examples of Poorly Written NCs

Non-conformance states:
 A required block torque test was not being performed.
(Classified as “Minor” yet a test not performed would be
detrimental to the integrity of the product.)
Non-conformance states:
 No preventative action records exist. (This would equate to an
absence of a quality management system element.)

Neither NC statement tells the client what went wrong...what

process is broken?

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 Writing of NC Statements
 Non-conformance: (Clearly define and document the systemic failure within the non-
conformance. You want ensure the client understands the exact nature of the non-
conformance. Too many words could mis-lead the client.)
 The system for the control of the “process for product design” failed to ensure
“authorization or approval was given prior to proceeding from Stage 2 to Stage 3
of the product design”.
 Objective Evidence: (Quote appropriate aerospace standard clause, work instruction,
procedure or process requirement)
 The Design/Engineering review record did not indicate authorization was given to
proceed to Stage 3 of the product design.
 Stated Requirement: (What objective evidence is/was used to indicate a
non-conformance existed? What record, document, procedure was used to
verify existence of a non-conformance)
 AS9100, Clause 7.3.4c, at suitable stages, systematic reviews of design
and development shall be performed in accordance with planned
arrangement; authorization is required for progression to the next design 40
stage.
 Accepting Closure of CAR Responses
The auditee’s corrective action response should cover three areas, as a
minimum:
 Containment of the current situation and identified systemic failure.
 Action to control or mitigate a problem; could includes correction,
corrective action.
 Root cause analysis as to why the system failed.
 Finally, a systemic corrective action to prevent a recurrence of a failure
in the system/process (could be preventive action may apply here.)

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 Action taken to fix non conformances
 Correction
 A Correction is when you fix the thing that went wrong (the nonconformity) This is
the immediate action to keep customers or management happy: rework the
product, replace the thing that’s not working right with one that does, or edit the
document requiring accurate information.
 Corrective action
 A Corrective Action, then, is described in 8.5.2 of the ISO 9001 standard as
something done to “prevent recurrence.” This is the thing you do to ensure the
nonconformity never happens again. It also requires some strategic thinking.
Therefore, it is crucial to always identify causes of nonconformities before
defining and implementing a Corrective Action.
 Action taken to fix non conformances
Effective corrective actions require a five-step process.
Nonconformity is identified,
Immediate Correction fixes the problem/product,
Root Cause Analysis identifies the weakness within your quality
management system that initiated the problem,
Corrective Action is implemented to prevent this problem from
recurring anywhere in your QMS again, and, finally,
Corrective Action Review (after an appropriate time delay) to
determine if the corrective action effectively prevented repeat
nonconformities of that type (in any product, for any customer).
 Action taken to fix non conformances
 A Preventive Action, on the other hand, has no relation to an
actual nonconformity. ISO 9001:2008 states a Preventive
Action’s function is to prevent the occurrence
of potential nonconformities

 This means nothing bad actually happened. While many of

the follow-up steps are the same, what initiates a preventive
action is very different. Preventive actions are improvements in
the system to ensure detrimental system gaps are addressed
before a nonconformity occurs. That’s the heart of proactive
improvement.
 Classify the following into correction/corrective/Preventive
actions
 Replacing the label on a device that had the wrong label
applied?
 Revising process parameters in response to complaints?
 Rewelding a contact that does not meet visual inspection
requirements?
 Auditing all vendors of a key component after quality issues with
only one vendor are identified?
 Revising equipment maintenance procedures to reduce drift in
process specifications?
Corrective Action Acceptance/Closure
 Does CA response address system process NC?
 Is Root Cause adequate?
 You must know and understand the process to accept
the CA and root cause.
 Does client’s response ensure no re-occurrence?

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 Scenario one
 During an audit, you read the Management Review
procedure. It states they have defined measurable
objectives for productivity, Customer satisfaction, and
quality. When you ask to see the measures looked at
during a management review meeting, the Plant
Manager hands you a 3 inch pile of papers. As you go
through the information, you notice there are plenty of
charts, graphs, and pivot tables. Seems like this place
measures everything they possible can, but there are no
goals listed or explanations for trends going in the wrong
direction.
 The Plant Manager understands each chart and is clearly
involved, but when asked how he uses them to drive
improvement, or how he knows if he is meeting his goals,
he has no answer. 47
Scenario one
You Should:
A. Do nothing, the thoroughness of the management review is
evidence that it is acceptable. Improvement, although
desirable, is not required.
B. Write an NCR because there has been no improvement and
therefore the management review is ineffective.
C. Write an NCR, as there is no evidence of defined measurable
quality objectives as stated in the procedure.

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Scenario one
The Correct answer is C: Write an NC.

 AS9100 Section 5.6.1 states, in part “that top management shall include
assessing opportunities for improvement of its effectiveness of it’s QMS.”
 The plant’s procedure stated they will have defined measurable objectives
for quality and none were found during this review.

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Scenario two
While auditing the purchasing department of Hector Aircraft
Components, you note that the purchasing procedure, HAC 123,
does not address positive recall per AS9100 section 7.4.3 paragraph
two, and the company’s process does not address periodically
validating test reports for raw material in accordance with section
7.4.3 paragraph three.
The QM, Hector, immediately corrects the master purchasing
procedure and saves the revised form in the company’s electronic
media. He demonstrates that the master purchasing document,
HAC Admin Form 01 now shows the requirement to validate test
reports, and that the procedure shows the positive recall
requirement.
You should:
A. Write an NC and accept it on site
B. Write an NC and leave it open
C. Do not write an NC because the issue has been resolved
D. Follow up to see if the company actually uses the new procedure

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Scenario two
You should:
A. Write an NC and accept it on site
B. Write an NC and leave it open
C. Do not write an NC because the issue has been resolved
D. Follow up to see if the company actually uses the new procedure

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 Scenario two
The Correct answer is B: Write an NC.

 When a major component of the quality system is missing, it requires an NC.

 Base on severity of NC, some NCs cannot be closed on site

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