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.
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);
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.
This QMSCAPA User Tip applies to the Document Control Module, and focuses on an alternate method of approving and verifying documents without using the QMSCAPA document change log and electronic approval journal.
Open a document control record form the Document Control Index or the Document Tree.
Go to Tab 2) Version Approval and History
#1) If any Required Approvals are checked, then uncheck these Required Approvals.
#2) Enter #1 into the [Verified] field.
#3) Check [Approval Verified] field.
#4) QMSCAPA will automatically place “Today’s Date” into the [Date Approved] field. Therefore, you may need to enter an appropriate [Date Approved]. Typically, the “Date Approved” should be prior to or equal to the [Effective Date] field.
#5) Go back to Tab 1) Document Description.
Return to Tab 1) Document Description
Check the [Use Alphanumeric] checkbox,
Verify the [Version Number] field version number matches the File-Naming-Convention (FNC) or by opening the document if the FNC does include the document version and effective date.
Verify the [Effective Date] field matches the effective date of the document attached and described in the Document Control Record.
Verify the contents in the [Document Status] field. If the document is approved and verified then select the appropriate Status. Example best practice, Approved, Uncontrolled when printed.
Select or enter the “Approved by Title” in the [Approved by Title] field.
Recommendation: Add a document description or purpose to the [Document Description/Purpose] field.
Statistical Process Control (SPC) is a method used in QMSCAPA software, among other Quality Management Systems, to monitor and control a process through statistical analysis. Here are some basic SPC tools and techniques found in QMSCAPA:
Control Charts: These charts help monitor process performance over time and identify variations. They distinguish between common cause variation (inherent to the process) and special cause variation (due to external factors).
Pareto Charts: These charts identify and prioritize the most significant factors in a process, helping to focus improvement efforts on the most impactful areas.
Histograms: These are bar charts that show the distribution of data, helping to understand the variation within a process.
Scatter Diagrams: These diagrams show the relationship between two variables, helping to identify correlations and potential causes of variation.
Cause-and-Effect Diagrams (Fault-Tree Diagrams): These diagrams help identify potential causes of a problem, organizing them into categories for easier analysis.
Check List/Sheets: These are simple forms used to collect and analyze data, often used for tracking defects or occurrences.
By using these tools, organizations can detect issues early, improve process stability, and enhance overall quality.
