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QMSCAPA Update QMSCAPA User Tips

QMSCAPA 2.32.1

QMSCAPA version 2.32.1 introduces important enhancements, more new reports, and direct print buttons.

Sales Quote and Contract Review

Two new direct print buttons have been added to the Sales Quote and Contract Review module to aid in the contract review requirements published of AS9100D and ISO 9001:2015 Quality Management Standards, which are paraphrased below:

AS9100D & ISO 9001:2015, Clause 8.2.3.1
The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to the customer, to include:

  • a. requirements specified by the customer, including the requirements for delivery and post-delivery activities;
  • b. requirements not stated by the customer, but necessary for the specified or intended use, when known;
  • c. requirements specified by the organization;
  • d. statutory and regulatory requirements applicable to the products and services;
  • e. contract or order requirements differing from those previously expressed.

This review shall be coordinated with applicable functions of the organization.

If upon review the organization determines that some customer requirements cannot be met or can only partially be met, the organization shall negotiate a mutually acceptable requirement with the customer.

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

Clause 8.2.3.2 The organization shall retain documented information, as applicable:

  • a. on the results of the review;
  • b. on any new requirements for the products and services.
Quote and Contract Review for AS9100D and ISO 9001:2015
QMSCAPA Contract Review module

In the image above (QMSCAPA Contract Review module:

  • a) Print Log (All);
  • b) Print Log (Sold);
  • c) Print Log (PWO) production work-order;
  • d) Print as Quote/Order with prices or without prices;
  • e) Print as Contract Review;
  • f) Print as PWO.

On-Time Delivery

The On-Time Delivery (OTD) Journal for OTD Per Shipment module was fixed and enhanced when validating “user defined” data labels and data in the form for the OTD Journal.

In AS9100D & ISO 9001:2015, Clause 8.1 Operational Planning and Control (paraphrased):

The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6, by:

  • determining the resources needed to achieve conformity to the product and service requirements and to meet on-time delivery of products and services;
QMSCAPA module for monitoring On-Time Delivery (OTD)

Guidance for USING QMSCAPA Reports Used in the Management Review Process

ABCI Consultants has updated its guidance for establishing and maintaining Management Review as a process by using QMSCAPA to document the Management Review inputs, which includes a plan for how the review shall be carried out taking into consideration:

  • a. the status of actions from previous management reviews;
  • b. changes in external and internal issues that are relevant to the quality management system;
  • c. information on the performance and effectiveness of the quality management system, including
  • trends in:
    • 1) customer satisfaction and feedback from relevant interested parties;
    • 2) the extent to which quality objectives have been met;
    • 3) process performance and conformity of products and services;
    • 4) nonconformities and corrective actions;
    • 5) monitoring and measurement results;
    • 6) audit results;
    • 7) the performance of external providers;
    • 8) on-time delivery performance (AS9100D)
  • d. the adequacy of resources;
  • e. the effectiveness of actions taken to address risks and opportunities (see 6.1);
  • f. opportunities for improvement.
Guidance for USING QMSCAPA Reports 
Used in the Management Review 
Process
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Download Guidance for USING QMSCAPA Reports Used in the Management Review Process

This ABCI guidance document refers to the following AS9100D & ISO 9001:2015 Quality Management Systems —
Requirements, beginning with Clause 9 Performance evaluation, 9.3 Management Review.