Here is what we've got...
Excerpt:
4.4 Quality Management System and Its Processes
4.4.1 QMS and Processes
Company, has established, documented, implemented and maintains a quality management system and strives to continually improve the quality systems effectiveness in accordance with the requirements of ISO 9001:2015 and AS9100 (D). Company's quality management system also addresses customer and applicable statutory and regulatory quality management system requirements.
a. Company has determined the inputs required and the outputs expected from Management, Manufacturing and Purchasing processes throughout the organization.
b. Process mapping has been prepared to show the sequence and interaction of these processes on the following pages. The PURCHASING PROCEDURE PU001 is also included in the sequence of the purchasing process.
c. Company has determined the criteria and methods needed to ensure that the operation and control of the processes yield their intended results. The criteria is as follows:
Manufacturing Process Metrics
• OTD 95% or greater
• Customer Acceptance 98% or greater
• < 5% Internal Scrap Rate
Purchasing Process Metrics
• Supplier OTD ≥90%
• Quality (Rejects) ≤10%
d. Top management uses input from process owners, quality review results, and management review input to ensure the availability of appropriate resources and information necessary to support the operation and monitoring of these processes.
e. Each process described is monitored, measured, and evaluated where applicable, and analyzed to provide a baseline for data, metrics and risk (AS9100D 6.1) for continual improvement of these processes. Process sequence and interaction flowcharts are found on the pages following.
f. These processes are managed by Company in accordance with the requirements of AS9100D. Authorities and responsibilities in the context of processes are addressed in Section 5.3 of this document.
g. Top Management will promote the process approach and risk-based thinking through daily status meetings.
Where Company chooses to outsource any process that may affect product conformity to requirements, Company takes the necessary steps to ensure control over such processes. The type and extent of control to be applied to these processes is defined within the quality management system. This involves qualification of the processor/customer-approved processor, providing specific processing requirements. These processes are controlled through the normal purchasing process.
Outsourced processes include but are not limited to the following:
• Heat Treating
• Calibration Services
• Surface finishing
• Special Manufacturing Operations
• Welding
• Painting
• Lab Raw Material Verification
Then there are flowcharts that I'm having trouble adding. I'll keep messing with it.
OK - what am I missing?
1. Clause 8.2 - Customer requirements - what are the KPI?
2. where are the KPI for Management?
These are typical questions from auditors - Based on Clause 8
Auditors also review any additional information that you are monitoring - on clause 4, 5, 6, 7, 9 & 10.
Key Performance Indicator (KPI)
Measures associated with goals or targets showing how well an organization is achieving its objectives or critical success factors for a particular project. KPIs are used to objectively define a quantifiable and measurable indication of the organization's progress towards achieving its goals.
NOTE: KPIs relating to an organization’s financial performance are not in the scope of the 9101 standard; however, economic measures (e.g., sales quotas, scrap value reduction) can be considered acceptable measures for process improvement. (9101)
Processes
A combination of people, material, machines, tools, environment, and methods that produce a product or service. [9013]
set of interrelated or interacting activities which transforms inputs into outputs.
NOTE 1: Inputs to a process are generally outputs of other processes.
NOTE 2: Processes in an organization are generally planned and carried out under controlled conditions to add value.
NOTE 3: A process where the conformity of the resulting product cannot be readily or economically verified is frequently referred to as a special process. (ISO 9000:2005) [IAQG-history]
