PEAR 4 Manufacturing - 20calibration Test
PEAR 4 Manufacturing - 20calibration Test
PEAR 4 Manufacturing - 20calibration Test
Process Effectiveness
Assessment Report
3 4
Organization: Sites: 4
OIN:
5
PEAR Number: 4 7
Issue Date:
8
Process Name: Manufacturing & Calibration
9
Process details, including associated process interfaces:
Manufacturing has interfaces with different department based on the type of project such as quality, materials, sales, and
Technical Staff. Shop travelers/routers (one customer) define the process sequence and include inspection points and
acceptance criteria. Written and Visual Work Instructions define how work is to be performed. Calibrated tools are identified
and used to accept product for customers. Risk Management is assessed throughout the process.
10
Applicable 9100/9110/9120 clause(s):
4.2.3, 4.2.2, 4.2.4, 5.2, 5.4.2, 6.2.1, 6.2.2, 6.3, 6.4, 7.1, 7.1.2, 7.4.1, 7.4.2, 7.4.3, 7.5.1, 7.5.3, 7.5.4, 7.5.5, 7.6, 8.2.1,
8.2.3, 8.2.4, 8.3 & 8.5
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Organization’s method for determining process effectiveness:
The process is determined to be effective when product is completed on time with no unexpected setbacks (first pass
yield/scrap/etc.) and/or non-conformances. Process effectiveness is ensured through several in-process inspection and test
steps. Dedicated technical staff are assigned to ensure configuration management is implemented successfully and risk is
evaluated at each step in the product realization process. Metrics and key indicators have been established to monitor
effectiveness as noted here: On time Delivery – Goal 1.80 Days - Actual 2.0 Days max, Quality Goal – 4.50 - Actual 4.8
max, Customer Satisfaction Goal 4.0 – Actual 4.9 max, Supplier Quality 4..5 - Actual 4.9 max
12
Auditor observations and comments supporting process effectiveness determination:
Verified Part #, Revision Letter, Serial Number (as applicable) and complete all configuration requirements for compliance
and effectiveness. Several gages and measuring devices asset were also reviewed for their calibration status and found
current. Presently, customers do not require FAIR per AS 9102. All products are inspected 100%. Company has an effective
NCR process and all NCR are clearly identified and traceable. MRB process is effectively implemented per procedure and
concessions are utilized when applicable. The product realization process reflect quality objectives, product requirements,
effective processes, proper documents, internal verification, validation, monitoring, measurement, visual inspection, and
verification of test activities reports, records, and product configuration as outline in the job travelers. The product / process
configuration management is suitable and effective. Control of work transfers including temporary or permanent transfers
are controlled per procedures / contingency plan and by verification of work conformity of all requirements (if applicable). If
and when a product is released to production prior to completing inspection, it is identified to allow recall if necessary.
Purchasing / Quality information (Terms and Conditions) defines information about the verification activities at the supplier's
premises. Production and service provisions are planned and achieved under controlled conditions including:, availability of
product characteristics, availability of necessary work instructions, use of suitable equipment, availability and use of
monitoring and measurement (M&M) equipment, implementation of M&M, implementation of product release, delivery.
There is suitable accountability for all products during production with each part or lots having a label attached to the lot or
products. Evidence that all operations have been completed as planned was verified. Foreign Object Damage and Debris
(FOD) program is suitable. Monitoring and control of utilities and supplies is critical and properly managed and an effective
preventive maintenance program is used on machines and equipment. A criterion for workmanship, managing critical items
and key characteristics is effective and maintained electronically. Special processes are composed of welding and
ocational shot peening activities, in addition to outsourcing those needed for the product. Product identification and
traceability is maintained by suitable means from receipt; during storage, packaging, and preservation; and until delivery.
Customer property is adequately controlled through the identification, verification, protection, and safeguarding. If product is
lost, damaged, or product unsuitable for use, then this is reported to the customer and records maintain. Products are
preserved during internal processing and delivery is effective. Preservation includes identification, handling, packaging,
storage, and protection, Preservation controls are applied to the constituent parts, Preservation of product includes
appropriate:, cleaning, foreign object controls, special handling for sensitive products, marking and labeling, shelf life control
and stock rotation, and special handling for hazardous materials (non present at this time).
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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.
9101:2009
9101:2009
FORM INSTRUCTIONS
APPENDIX C – PROCESS EFFECTIVENESS ASSESSMENT REPORT (PEAR)
General rules for use/application of PEAR:
At a minimum, the results for 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.
14 Name and signature of the auditor(s) who assessed the process and completed the
PEAR.
NOTE: Electronic signature may be used; in this case the following text can be added: 'signature
on file’ or ‘electronic signature available', or similar.
15 The name and signature of the Auditee representative (e.g., the process owner or
Management Representative) for acknowledgement.
NOTE: Electronic signature may be used; in this case the following text can be added: 'signature
on file’ or ‘electronic signature available', or similar.
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