AS9100D PEAR - Examples for organization's method for determining process results?

#1
I am working on AS9100D Certification; we already have ISO 9001 and 13485. I've searched other threads but haven't found this; if it's a repeat just point me in the right direction please.

I'm having trouble coming up with process results and KPI's for two of our key processes - "Receiving and Inspection" and "Packaging and Shipping". My company is a small contract manufacturer (65 employees). The fact that I can't think of any KPI's makes me think maybe they shouldn't be stand alone key processes? It doesn't seem quite right to combine them with Assembly though. Any insights?
 
Elsmar Forum Sponsor

Techster

Starting to get Involved
#2
Receiving and inspection is that incoming parts and/or raw material from external suppliers?
If so I would have On Time Delivery and some sort of rejected PO/total Amount of PO.
Packaging and shipping could be number of claims because of packaging/total numbers of delivery lines and also on time delivery at your customer.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Critical to remember that the 3 standards you are referencing, ISO 9001, ISO 13485 and AS9100 are QUALITY system standards, so the key aspect is to measure these processes from the perspective of PRODUCT CONFORMITY and CUSTOMER SATISFACTION.

As for receiving and (assume receiving) inspection, a KEY indicator related to quality would be these processes ability to effectively screen good from bad parts. Do you ever have instances where components are being assembled and production discovers that the wrong or defective components were received? If that ever happens in your assembly line, it is a sign that receiving/incoming inspection FAILED to screen that parts. If you come up with an indicator of this yield, that would be a good KPI for these processes.

As for packaging and shipping, does it ever occur that customers complain receiving damaged and/or incorrect parts? Wrong quantity? Missing parts? Late arrivals? Wrong shipping method? Those would be typical (quality) indicators of problems in those processes.

Good luck.
 
#4
Critical to remember that the 3 standards you are referencing, ISO 9001, ISO 13485 and AS9100 are QUALITY system standards, so the key aspect is to measure these processes from the perspective of PRODUCT CONFORMITY and CUSTOMER SATISFACTION.
Thanks for that. It's a good reminder.

For "Receiving and Receiving Inspection" that was what I came up with as well. It would be something like "# errors" with a goal of zero, to be measured by what gets put on non-conforming hold that the Material Review Board determines was received incorrectly or missed at receiving inspection. The concern I have with that is those errors are really rare. In the past two years, it's happened once. Would the auditor be okay with a long string of zeros with very little variation in the data? If I saw data like that, I would probably be suspicious of how real it is just because that's not how data behaves. Or does that just show our process is working well and planned results are achieved?

The same thing with shipping - we seldom have errors and none in the last year. It would be another long string of zeroes.

My background is much more statistics focused than regulatory, so maybe I'm making too much out of what the data will look like. ( I would also far rather have a positive metric than a negative one (% correct instead of # errors) but it's much more difficult to keep track of. And, there would still be the problem of the lack of variation in the data.)
 

Big Jim

Super Moderator
#5
If you pay attention to topics that you need to perform analysis and evaluation to look at 9.1.2, 9.1.3 and 5.1.2. From that you should come up with customer satisfaction, product quality, on-time delivery, and supplier performance. Even if you don't choose to use these topics as KPI, you still need to be doing it, so why not also use them as KPI to fulfill the requirement to monitor and measure your processes as shown in 4.4.

From these topics, receiving and inspection could be measured by tracking supplier performance. They are in integral part of keeping the suppliers honest. Packaging and shipping could be measured by tracking on-time delivery. If they are not paying attention to getting things out in time on-time delivery could be hurt.

Since you brought it up, receiving and inspection can easily be rolled into purchasing where it addressed in the standard and packaging and shipping could easily be part of production (assembly) (or even rearrange with production as the process and include the activities of assembly and packaging and shipping included within).

It is up to the organization to determine what their core processes are and their can be many ways to accomplish it. Just letting you know there is room for you to roll them into others if you so desire.
 
Thread starter Similar threads Forum Replies Date
K AS9100D - Is the PEAR required? Internal Auditing 1
M AS9100D Process Map Requirements - PEAR Forms AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
A AS9100D 8.1.4 Prevention of Counterfeit Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B AS9100D Sampling Plan AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What To Clauses Exclude - AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
F AS9100D Internal auditing requirements Internal Auditing 3
A AS9100D FAI requirements needed? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
C AS9100D -8.5.1j - Accountability For All Products Tiny Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Free downloadable AS9100D audit checklist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K AS9100D Clause 7.5.2.a) - What is considered to be "documented information"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
Nicole Desouza AS9100D - Calibration of Dies & Tooling - Plastic Extrusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C Taking exception to customer requirements or specifications & AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
I AS9100D Non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f - Corrective Action AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M AS9100D Competence and Training Records - X-Ray AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P Design exclusion in AS9100D for commercial products AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
N Claiming exemptions (N/A) in AS9100D - what is the methodology and location? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D AS9100D implementation question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Y Time gap for First Surveillance Audit of AS9100D after initial certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
H AS9100D Cert question - Small machine shop - Where can I buy a certificate? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M AS9100d Controlling External Provided Processes (purchasing 8.4) - The customer want us to use supplier X AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C AS9100D 7.1.5.2 / Calibration of Employee Owned Measuring Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A CAR from 3rd party AS9100D auditor - Root cause dilemma AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
Q AS9100D Corrective Action Procedure needed Document Control Systems, Procedures, Forms and Templates 1
A What does a good business practice Process Audit look like for AS9100D? Process Audits and Layered Process Audits 9
J AS9100D - Good ways to document an internal audit plan / schedule Internal Auditing 25
C AS9100D, Clause 8.1 - Operational Planning and Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
C AS9100D Contract Review Contract Review Process 8
J What to expect during a Change of Location Audit under AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L AS9100D Requirements vis-a-vis Section 8.5.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J AS9100D Cl. 8.4.3d - The organization shall communicate to external providers... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J AS9100D Sections related to 1st Piece and In-Process Inspection Manufacturing and Related Processes 15
M CB and Internal auditors most common nonconformities against AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
D AS9100D vs AS9120B differences AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J AS9100D Clause Brain Fade - Tool was past due for Calibration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C AS9100D Flag AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K Maintenance requirements for Production Equipment in AS9100D General Auditing Discussions 8
I Trying to explain some of the Management Review Inputs (AS9100D) Management Review Meetings and related Processes 10
K AS9100D production process scheduling requirements Internal Auditing 14
D AS9100D 7.3 Awareness of customers quality policies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18

Similar threads

Top Bottom