RMC Use of PEAR's Auditing Application

Registration Management Committee (RMC)
Use of PEAR’s
Auditing Application of AS9101
Boston, MA
July 21-22, 2011
Henry Gamboa
UL DQS Aerospace Program Manager
Michelle Barton
UL DQS Senior Lead Assessor/Reviewer
Auditor Workshop
Boston, MA
Company Confidential July 21-22, 2011 1
PEAR Definition
• A PEAR is a document stating results and providing
evidence of determination on the effectiveness of a
process.
Company Confidential
PEAR Intent/Purpose
• The PEAR was introduced to provide a tool that
allows the auditor to systematically evaluate the
effectiveness of a process based on the organizations
method for monitoring and measuring their
processes.
What is Effectiveness?
• It is the extent to which planned activities are realized
and planned results are achieved
• (Reference ISO 9000 Quality management systems – Fundamentals

and Vocabulary)
What is Effectiveness?
In other words, is the process effective in:
• Fulfilling customer requirements?
• Delivering quality products, on time?
• Improving continually?
• Meeting established goals and objectives?
More than just a conformity assessment!
• What will this Mean to the Auditor?

• Review and examine an organization’s
“Effectiveness” from:
– The customer viewpoint; satisfaction and performance.
– Organizational leadership goals and objectives.
– Alignment of process performance measures with
quality objectives and customer requirements.
– Criteria used for deciding what data to analyze for
determining process effectiveness.
General rules for use/application of a

PEAR:
• At a minimum, the results of each audited product
realization process, as determined by the
organization (reference 9100-series clauses 4.1 and
7.1), shall be recorded on a PEAR.
• Each assessed process shall be recorded on a
separate PEAR.
• There is no preset minimal number of PEAR’s required
from an audit
To what level of detail does a process have to

be to require a PEAR?
• Consider what defines a process – inputs, outputs, process owners,
etc.
– If they are the same, then a higher level PEAR might be
appropriate.
– If they are not the same, then 2 separate PEARs should
be created.
• In determining the appropriate level reference the Form Instructions
for the the QMS Process Matrix Report (Appendix D) – it shows that
Product Realization includes: Manufacturing-Machining,
Manufacturing-Paint, Manufacturing – Assembly, etc.
When does a PEAR have to be done?

• Reference quality manual & other QMS
documentation for description and sequence of
interaction of processes
• At a minimum, the results of each audited product
realization process, as determined by the
organization (reference 9100-series clauses 4.1 and
7.1), shall be recorded on a PEAR
• Will discuss more during group activity
New Focus on Audit Planning in AS9101D

• The AS9101D now requires substantial review of
information/data in preparing for audits.
• Included in this data is the identification of processes
including their interactions and sequencing.
• The identification of these processes will then be used in
preparing the audit plan/agenda and to identify the PEAR
processes.
Process Based Audit Tool is an Input into the

PEAR
• The information that is recorded on the process
based tool will then be an input for the completing the
PEAR later.
• Process Based Audit Tool is an Input into the

PEAR (cont.)
Collection of Data (4.3.2.2 of AS9101D) -
NOTE 1: The processes can be depicted in various ways [e.g., process
maps, turtle diagrams, SIPOC method (breakdown of supplier,
inputs, process steps/tasks, outputs, customer), octopus].
AATT training -
Whatever audit tool is used, it should include process control
methods for monitoring and measuring process effectiveness.
Electronic Assembly Turtle
Aerospace Process Turtle
Process name: Electronic Assembly Process
owner:
Critical success factors: Maintain schedule and zero failures Start event:
End event:
Process input Resources / material Process personnel Process output

(with what?) (with whom?)
Material noted in BOM Techniciians trained to J-Std and Completed assemblies

Kitted Assembly with Test Equipment, wire bonders Completed records
IPC-610, Mfg Self Inspection,
Traveler Prod Equipment/Testing Secret Clearance, ESD Training
BOM
Pick List
Instructions Process:
MRP Need Date Process steps / main activities:
iiiiiiiiiiiiiiiiijjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjjj
Assemble per drawing –

Supplier for process /
Tune & align unit – pre-cap Customer of process /
Previous process inspection – laser weld lid Next process
Stockroom Interfaces for input – environmental test – final Interfaces for output
Next level assembly
Production Control
test – paint & label – final
Maintenance inspect Production control
Calibration
Engineering
Planning
Quality
Process indicators Process objectives /

(how many?) Purpose
RMA levels, OTD, FPY 1% RMA or less, 90% OTD,

98%FPY
SWOT Analysis Reference documents (how?) Process Improvement

Process map Notes
UL-DQS Inc. Aerospace Process Effectiveness
Assessment Report
Organization: Site: OIN:
PEAR Number: Audit Report Number: Issue Date:
Process Name:
Process details, including associated process interfaces:
Process Details/Interfaces
Applicable 9100/9110/9120 clause(s):
Organization’s method for determining process effectiveness:
Auditor observations and comments supporting process effectiveness determination:
Statement of Effectiveness Level:

The process is:
1. Not implemented; planned results are not achieved.
2. Implemented; planned results are not achieved and appropriate actions not taken.
3. Implemented; planned results are not achieved, but appropriate actions being taken.
4. Implemented; planned results are achieved.
Auditor Name(s): Auditee Representative Acknowledgement

Name:
Signature(s): Signature(s):
Process Details/Interfaces
• Form Completion Instructions from AS9101D - Summarize
the process activities, inputs, and outputs; including the
identification of associated process interfaces.
Process Details/Interfaces –
Example for Electronics Assembly Process
• Inputs into the process include traveler, BOM, pick list, work instructions,
kitted assembly & MRP need date. Process flow is as follows: “Assemble
per drawing – Tune & align unit – pre-cap inspection – laser weld lid –
environmental test – final test – paint & label – final inspect.” The outputs
include completed assemblies and completed assembly records. Process
interfaces include production control, planning and engineering.
Question: Is there something that could be added to this description of
process details/interfaces?
Answer: The specific details of the process flow sequence alone does not
highlight potential risk factors in meeting customer requirements and
measureable objectives of the process.
Same Example, Different Write up

• Inputs into the process include kitted assembly and build paperwork & MRP
need date. Process flow is as follows: “Assemble per drawing – Tune &
align unit – pre-cap inspection – laser weld lid – environmental test – final
test – paint & label – final inspect.” The nature of the product developed and
manufactured in the organization requires highly specialized and state of
the art microwave/hybrid processes. The product itself can be very complex
and on occasion requires frequent design and development changes. The
outputs includes completed assembly and assembly records. Process
interfaces include production control, planning and engineering.
Question: Why is this process description better than the previous?
Answer: Because it highlights potential risk factors (product complexity,
frequent design changes) in meeting customer requirements and
measurable objectives of the process.
Assessment Report
Process Name:
Organizations method for determining

process effectiveness

The process is:

Name:

process effectiveness
• Form Completion Instructions from AS9101D - Describe
the method used by the organization to determine process
effectiveness [e.g., identification of Key Performance
Indicators (KPIs) and associated targets, process
capability data].

process effectiveness –
Example for Electronic Assembly Process
Organizations method for determining process effectiveness -
• Quality and on time delivery is tracked periodically.
Question: What is wrong with this description?

Answer: Description is too brief and does not tell how quality is tracked
(e.g., 1st pass yield, RMA levels, scrap, etc.). It also does not tell how
often quality and on time delivery is tracked and by whom.
Organizations method for determining process

effectiveness
• 1st pass yields and on-time delivery is tracked daily and discussed during
daily production meetings with cross functional teams. This information is
summarized and reported monthly by the quality manager to the general
manager. The general manager will go over this information on a quarterly
basis with all employees during state of the company meetings.
Question – Why is this example better than the previous?
Answer – Because description is more thorough and describes how quality is
tracked (1st pass yields). It also mentions how often quality and on time
delivery is tracked (daily production meetings, monthly reporting to GM and
quarterly state of the company meetings)
Assessment Report
Process Name:
Auditor observations & comments supporting

process effectiveness determination

The process is:

Name:

• Form Completion Instructions from AS9101D - Annotate
relevant objective evidence, observed conditions, data,
information, comments, etc. to support the auditor's
statement of effectiveness or ineffectiveness

Electronic Assembly Process Example
• Assessed 5 items through the assembly process. Work instructions were
available for the operator at stations in each of cells. Talked with 6 operators
all who knew the quality policy. Records were available for review. All
gauges had calibration stickers on them. Verified the training records for
each of the employees interviewed and all had records of competence for
activity observed performing.
• Question: What is wrong with this description?
• Answer: This description gives the evidence of compliance that was
assessed. It does not address the effectiveness of the process. Based on
this information the reader of the PEAR would not be able to determine what
Level the process is performing to.
• Auditor observations & comments supporting

• On time delivery target of 95% has not been met for the past 12 months.
Average for past 3 months has been slightly below 75%. Factory is running
at capacity according to Manufacturing Manager. Actions taken include
hiring 2 new swing shift technicians and 7 new day shift technicians. Also,
training of technicians of highly specialized processes is on-going. In
addition, action is planned to automate some of the existing tuning and
testing processes which should help improve delivery. Also, weekly material
status meetings are having a positive impact to schedule according to area
manager.
• Question: Why is this better than the previous response?
• Answer: This description tells of the performance of the process that was
observed during the audit rather than identifying the evidence of
conformance.
Assessment Report
Process Name:
Determining the appropriate

level of effectiveness
The process is:

Name:
New Levels of Effectiveness introduced

in PEAR documents.
1) Process not implemented; planned results are not
achieved?
2) Process implemented; planned results are not
achieved and appropriate actions not taken?
achieved, but appropriate actions being taken?
4) Process implemented; planned results are achieved?
Determining the appropriate level of effectiveness

Form Instructions –
Indicate to what extent the audited process was determined effective.
Effectiveness: extent to which planned activities are realized and
planned results achieved (reference ISO 9000).
NOTE 1: A major (ma) NCR shall be issued when the effectiveness

level of the process is rated a "1".
NOTE 2: A major (ma) or minor (mi) NCR shall be issued when the
effectiveness level of the process is rated a "2" (see nonconformity
definitions in clause 3).
Determining the appropriate level of effectiveness

• What is written in the previous 2 sections should
support this determination.
– In essence, the reader of the PEAR should already know
what level the process is performing at before looking
at the checked box.
Example of Determining Effectiveness Level
Electronic Assembly Process

• On time delivery target for electronic assembly process of 95%
has not been met for the past 12 months. Average for past 3
months has been slightly below 75%. According to the Assembly
Manager, the factory is running at capacity but he has not been
able to find new qualified technicians for hire required for some
of its highly specialized processes. Performance data posted in
the assembly area shows that electronic assembly has been
running on over time for the past 9 months and 1st pass yield
targets have not been met. RMA levels during this time frame
have exceeded the goal of 1% or less for product shipped and is
currently at 3%.
What level of effectiveness would you

assign?
achieved?
Example of Determining Effectiveness Level

• On time delivery target of 95% has not been met for
the past 12 months. Average for past 3 months has
been slightly below 75%. Factory is running at
capacity according to Manufacturing Manager.
Actions taken include hiring 2 new swing shift
technicians and 7 new day shift technicians. Also,
training of technicians of highly specialized
processes is on-going. In addition, action is planned
to automate some of the existing tuning and testing
processes which should help improve delivery. Also,
weekly material status meetings are having a positive
impact to schedule according to area manager.

assign?
achieved?
Example of Determining Effectiveness

Level
• On time delivery target of 95% has not been met for the past 12
months. Average for past 3 months has been slightly below 55%.
Several key personnel have left the organization since the last
surveillance due to retirement and other reasons. Replacements
have not been trained and there are no plans to have them
trained until the next big contract is awarded. Furthermore, many
of the assembly processes have not been documented and there
seems to be a dependence on tribal knowledge on how to get the
job done. Several production travelers sampled contained
operations that were not signed off and had inspection
operations that were by-passed. Customer complaints and
RMA’s have tripled in the past 9 months.

assign?
achieved?
Group Activity
Credits & Acknowledgements

• IAQG AS9100 Team
Questions?

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Registration Management Committee (RMC)

• (Reference ISO 9000 Quality management systems – Fundamentals

• What will this Mean to the Auditor?

General rules for use/application of a

To what level of detail does a process have to

When does a PEAR have to be done?

New Focus on Audit Planning in AS9101D

Process Based Audit Tool is an Input into the

• Process Based Audit Tool is an Input into the

Process input Resources / material Process personnel Process output

Material noted in BOM Techniciians trained to J-Std and Completed assemblies

Assemble per drawing –

Process indicators Process objectives /

RMA levels, OTD, FPY 1% RMA or less, 90% OTD,

SWOT Analysis Reference documents (how?) Process Improvement

PEAR Number: Audit Report Number: Issue Date:

Process details, including associated process interfaces:

Organization’s method for determining process effectiveness:

Auditor observations and comments supporting process effectiveness determination:

Statement of Effectiveness Level:

Auditor Name(s): Auditee Representative Acknowledgement

Same Example, Different Write up

PEAR Number: Audit Report Number: Issue Date:

Process details, including associated process interfaces:

Applicable 9100/9110/9120 clause(s):

Organizations method for determining

Statement of Effectiveness Level:

Auditor Name(s): Auditee Representative Acknowledgement

Organizations method for determining

Organizations method for determining

Question: What is wrong with this description?

Organizations method for determining process

PEAR Number: Audit Report Number: Issue Date:

Process details, including associated process interfaces:

Applicable 9100/9110/9120 clause(s):

Organization’s method for determining process effectiveness:

Auditor observations & comments supporting

process effectiveness determination

Auditor Name(s): Auditee Representative Acknowledgement

Auditor observations & comments supporting

Auditor observations & comments supporting

• Auditor observations & comments supporting

PEAR Number: Audit Report Number: Issue Date:

Process details, including associated process interfaces:

Applicable 9100/9110/9120 clause(s):

Organization’s method for determining process effectiveness:

Determining the appropriate

Auditor Name(s): Auditee Representative Acknowledgement

New Levels of Effectiveness introduced

Determining the appropriate level of effectiveness

NOTE 1: A major (ma) NCR shall be issued when the effectiveness

Determining the appropriate level of effectiveness

Example of Determining Effectiveness Level

Electronic Assembly Process

What level of effectiveness would you

Example of Determining Effectiveness Level

Electronic Assembly Process

What level of effectiveness would you

Example of Determining Effectiveness

What level of effectiveness would you

Credits & Acknowledgements

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