By Brandon Kerkstra

Overall Changes and Important Additions from Revision “B” and ISO 9001.

The focus of the AS9100C requirements added to ISO 9001 is on the Aerospace & Defense Industry needs.  An important point is that a company currently registered to ISO 9001 that also has automotive requirements such as APQP, FMEA & PPAP built into their system or with staff that is familiar with these requirements will have an easier time upgrading their current system.

Production Process Verification (Basically the “First Article Inspection” FAI) and Work Transfer processes are AS9100 Specific, but companies experienced in PPAP will find that they are quite prepared to meet these requirements.

The main new requirements in AS9100C focus on: Project Management, Risk Management, and changes to Configuration Management.  A company with a strong, documented design and product launch process will find that they meet many of these requirements and will have appropriate process in which to add any additional items required.  Companies that do not have formal processes for the above items will find a great amount of benefit in establishing and implementing these processes (Increasing efficiency & quality and reducing risk).

Registration / Certification Note:  Most registrars are not expecting to be qualified to register companies to the new revision until late 2009 or early 2010.  This gives companies that are currently registered to AS9100B and companies working on implementation time to address the changed requirements.

Goal and Objectives of Changes to AS9100C as defined by IAQG

·         Incorporate ISO 9001: 2008 Changes

·         Expand the AS9100 scope to include Aviation, Space & Defense (Land and Sea based systems)

·         Increased focus on on-time and on-quality deliveries

·         Clarify where documented procedures are required

·         Expansion of scope to include:

o       Risk Management

o       Project Management

o       Configuration Management

o       Critical Items and special requirements

·         There was extensive stakeholder involvement in revision effort to ensure the standard was recognized by many different industry “Customers” and regulatory bodies.
 

Key Changes to the standard requirements:  (AS9100B to AS9100C)

As defined by International Aerospace Quality Group (IAQG), there are:
6 additions, 8 revisions, 3 deletions

Additions

·         Risk is now defined in the definitions section (Cause 3.1)

o       An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.

·         Special requirements is now defined in the definitions section (Cause 3.2)

o       Those requirements which have high risks to being achieved thus, requiring their inclusion in the risk management process

o       Factors used to determine special requirements include

§         Product or process complexity

§         Past experience

§         Product or process maturity

o       Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industry’s capability, or requirements determined by the organization to be at the limit of its technical or process capabilities

·         Critical items is not defined in the definitions section (Cause 3.3)

o       Those items (e.g. functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include

§         Safety critical items

§         Fracture critical items

§         Mission critical items

§         Key Characteristics

o       The Key characteristic requirements have not been revised, but a new note is added to identify special requirements from the Customer or internal sources that require additional controls (e.g. risk management). These translate into Critical Items that may flow to Key characteristics for variation control.

·         Customer focus / satisfaction (Clauses 5.2 & 8.2.1) – Top management shall ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be achieved (5.2)

o       Information to be monitored and used for the evaluation of customer satisfaction shall include, by is not limited to:

§         Product conformity

§         On-time delivery performance

§         Customer complaints

§         Corrective action requests

o       Organizations shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results (8.2.1)

o       The intent of these requirements is to drive the use of the quality management system to improve overall organizational performance

·         Project Management (7.1.1) – New requirement for planning and managing product realization in a structured and controlled way to meet requirements at acceptable risk, within resource and schedule constraints.

·         Risk Management (7.1.2) – New requirement to implement a risk management process applicable to the product and organization covering

o       Responsibilities for Risk Management

o       Identification, assessment and communication of risks

o       Definition of risk criteria,

o       Mitigation of risks

o       Acceptance of remaining risks

o       Note - The concept is integrated within the revised 9100

The following is a diagram that explains the Risk Management process as described by the IAQG:

Revisions

·         Scope extended to include Defense as well as aviation and space

o       Application guidance to address when AS 9100, 9110 (Maintenance) and 9120 (Distributor) are applicable

·         QMS General requirements (4.1) – The organizations QMS shall address customer and applicable statutory and regulatory QMS requirements (This was moved from 4.2.1 for clarification)

·         Configuration Management (7.1.3) –Moved from cause 4.3, structured with ISO 10007, and focuses configuration management on the product throughout product realization process.  Additional requirements to address as applicable:

o       Configuration management planning

o       Configuration identification

o       Change control

o       Configuration status accounting

o       Configuration audit

·         Work Transfer (7.1.4) – Moved from 7.5.1.4.  The organization must have a process to plan, control and verify the transfer activities.

o       Expanded to cover permanent transfer

o       More emphasis on planning and control of transfer activities

·         Recognition of supplier quality Data (7.4.1) – added note to recognize that one factor that may be used during supplier selection and evaluation is objective an reliable data from external sources.  Organization is still responsible to verify purchased products.

·         Approval status for suppliers (7.4.1) – added and provided examples of approval status (Approved, conditional, disapproved) and examples of Scope of Approval (Product type, process family).  The organization must define the process for suppliers approval status decisions or changes.  Risk analysis is also required here.

·         Production Process verification (7.5.1.1) moved from 8.2.4.2.  This used to be called “First Article Inspection (FAI)” Requirement to verify the production processes, documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g. Engineering , manufacturing, or  tooling changes)

·         Sampling Inspection (8.2.4) – When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriate for use (Matching the sampling plan to the criticality of the product and to the process capability)

Deletions

·         Clause 4.2.2 – requirement to create a document showing the relationship between 9100 requirements and the organizations documented procedures was removed.

·         Clause 7.4.3 Validation of test reports – Where the organization utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw material.

·         Clause 8.2.2 Detailed tools and techniques – “Detailed tools and techniques shall be developed such as check sheets, process flowcharts, or any similar method to support audit of the quality management system requirements.  The acceptability of the selected tools will be measured against the effectiveness of the internal audit process and overall organization performance.