Category Archives: ISO 9001

Risk Assessments and Management Methods for ISO Management Systems

Important enhancements have been made to the QMSCAPA™ software module for Risk Assessments and Management.

The QMSCAPA Risk Assessment (RA) module consist of:

  • Table of Risk Assessments (current and historical assessments)
    • A sub-table of specific aspects of the risk assessments
    • A look-up table of the risk impact values with regard to the
      • Probability (P) {likelihood}
      • Severity (S) {impact}
      • Detection (D) {overall detection ability reduces risk
    • Five user-defined boundaries, e.g. Very Low, Low, Medium, High, Very High.

The impact values are used to calculate the Risk Priority Number (RPN) for each aspect.

RPN = (P * S * D)

The module is developed around the concepts typically found in a Failure Mode Effects Analysis (FMEA).

The single-user version of QMSCAPA software may be downloaded free of charge, simply click here to join the QMSCAPA users-group.

The Risk Assessments browse table can store a large number of current and/or historical assessments.

  1. The browse window contains sort tabs for instant viewing of data according to the key value of the Tab.
  2. Risk assessments can be performed and recorded for virtually any type of risk related to the organization, relevant interested parties, product, service, staff, logistics, transportation, and cost, including environmental, health and safety.
  3. View RiskAspects button: Opens a sub-table of related aspects to the highlighted risk assessment may be viewed, added, edited or deleted as needed.
  4. RIP icon button: Access the Relevant Interested Parties table (RIP).
  5. Print Assessment button: Use the button to print a Risk Assessment, which includes all aspects and impacts recorded.
  6. Copy Assessment or Template button: The copy button control copies the currently highlight assessment record.
  7. The tab 10) Templates applies a filter that only shows the Risk Assessments designed to be templates.

The Risk Aspect module form is configured with 4 main Tabs or sections:

  1. The General Tab contains information about the failure (generic for incident, breach, non-conformance). The assessment calculation tool (pre and post mitigation results) is designed for rating or assessing a specific aspect of the Risk identified and associated in the Risk Assessment Table. Therefore, a one to many relationship exist between the Risk (parent table) and the Aspects (child table).
  2. Tab 2) contains fields for additional consequences.
  3. Tab 3) contains fields for mitigation or risk treatment actions.
  4. Tab 3) contains a method of generating risk impact statement based upon availability, confidentiality, integrity and financial effect.

1) General tab

(A) In the form image below/right, Describe the failure and the failure mode.

(B) Describe what may cause the failure and the failure effect.

(C) The impact values for calculating the Risk Priority Number (RPN) (pre-mitigation treatments); see the look-up table for impact values:

  • RPN = Probability (P) * Severity (S) * Detection

(D) The impact values for calculating the Risk Priority Number (RPN) (post-mitigation treatments);

(E) Look-up Tables for Response to Risk Aspect and the current/last Status of the Risk Aspect.

(F) The RPN can report the pre or post-mitigation action [√] RPN Post Mitigation Action is check-box.

Additional QMSCAPA risk assessment and management information has been published at qmscapa.net.

ISO 9001:2015 Implementation Guidance & Document Templates Kit

The ‘2015 version’ of our ISO 9001 Implementation and Guidance Kit is available as a Microsoft Word (.docx files) template set that addresses all clauses in ISO 9001:2015.

The documents (plans and procedures) were first developed to assist ISO 9001:2008 management system users to transition to the ISO 9001:2015 framework.

QMSCAPA Software is included and offers a complete set of controls and performance monitoring tools required by the ISO 9001:2015 Standard.


The ISO 9001:2015 Implementation Guidance Kit contains:

QMSCAPA provides controls and methods for Corrective Actions, Customer Satisfaction (surveys), Documented Information Management, Evaluating Suppliers, Internal Auditing, Measuring Devices, Measuring Key Performance (KPI), Measuring Objectives, Product Life-Cycles, Risk Assessments, Training Validation, plus much more.

  • An ISO 9001:2015 Learning Guide;
  • A Quality Management System (QMS) Template for a Plan [file name: ISO 9001-2015 QMS Plan v01 (Draft 1)];
  • And the following examples of Quality Procedures (QP) Templates:
  1. QP-0410 Context of the OrganizationMicrosoft Word Compatible Files
  2. QP-0440 Quality Processes
  3. QP-0520 Quality Policy
  4. QP-0530 Roles & Responsibilities
  5. QP-0610 Risk and Opportunity Management
  6. QP-0620 Quality Objectives
  7. QP-0630 Change Management
  8. QP-0714 Business Environment
  9. QP-0715 Monitoring & Measurement Device Control
  10. QP-0720 Training
  11. QP‐0750 Control of Documents and Records
  12. QP-0810 Production Planning
  13. QP-0823 Contract Review
  14. QP-0830 Product Design and Development
  15. QP-0830 Packaging Design and Development
  16. QP-0840 Purchasing Services and Materials
  17. QP-0851 Production Process
  18. QP-0853 Customer Property
  19. QP-0854 Preservation of Product
  20. QP‐0870 Control of Nonconformances
  21. QP-0912 Measuring Customer Satisfaction
  22. QP‐0920 Internal Audits
  23. QP-0930 Management Review
  24. QP‐1020 Corrective Action
  25. ISO 9001:2015 Auditor Checklist

Includes Free support for the Microsoft Word templates and QMSCAPA software through email, and optional real-time support is also available on a hourly fee basis.

Evaluating and Scoring Suppliers

I have developed a prototype quality management Excel spreadsheet tool for evaluating, scoring and approving suppliers.

Be sure to join our Quality Managers User Group to download the Excel workbook and the work instructions, which are described below.

Click here to Join our User Group or Download our resources.

Jack T. Bogle, Managing Partner
abci-consultants.com

Supplier Evaluation & Scoring Calculator Log.xlsx

The following table describes the features in the Supplier Evaluation Excel Workbook, which is shown above.

  1. The Active Suppliers field is automatically tallied when a 1 or 0 is entered into Column A.
  2. A supplier can be marked active or inactive by entering a 1 or 0 into Column A.
  3. The Minimum Score Required to be APPROVED field is user-defined and intended to mean the minimum scored needed to indicate an approved supplier.
  4. The Over-all Experience with a supplier is an average score of all suppliers.
  5. Enter up to 100 suppliers for evaluation.
  6. Enter the date of the last evaluation and the next evaluation date is automatically generated.
  7. If the (H) Supplier Score in less than the (C) Minimum Score Required to be APPROVED, then the (G) Approval Status automatically becomes ‘Not-approved’, else the Status becomes ‘Approved’. The ‘Provisional’ column to the right of the Approval Status column is meant to be used for indicating that a supplier ‘Not-approved’ may be used as needed.
  8. The average individual Supplier Score.

 

Supplier Evaluation & Scoring Calculator Log.xlsx

(not within the print area)

The image below shows the Excel columns not intended for printing.

  1. The Supplier Evaluation Criteria should be entered into row 1, columns G1 through Q1.
  2. The over-all average score and the average score for each supplier is displayed on row 2, columns G1 through Q1.
  3. Section (C) shows the individual scores for each supplier.
  4. Section (D) shows the individual criteria score for each supplier.

A Supplier Evaluation form is located in the Excel Workbook, Supplier Form tab/worksheet.

 

Supplier Name

Contact:

Email:

Phone:

Evaluation Completed by:

Date:

Complete the survey below to provide an evaluation of the supplier. Using a scale of 1 through 10; a 1 would indicate that you are very dissatisfied with the supplier, a 5 would indicate indifference and a 10 would indicate that you are very satisfied.

# Component Rating Key: 1 = Very Dissatisfied – 5 = Neutral – 10 = Very Satisfied Rating

Rate your experience with the supplier’s Sales personnel. Were the personnel prompt, professional, and courteous?

2

Rate your experience with the receipt of orders. Are orders correct as ordered?

Rate your experience with on-time delivery. Did you receive the product on-time as expected?

Rate your impression of the quality of the product ordered.

Rate your impression of the value received for the product ordered.

Rate your experience with the packaging and intact delivery condition.

Results of Supplier Quality Survey.

Rate the experience with the supplier’s Customer Services. Were the personnel prompt, professional, and courteous?

Rate your experience with the product realization compared to product specification.

10•

Rate your over-all experience with doing business with the supplier. Would you recommend this supplier to others for the products and experience that you have received?

TOTAL RATING:

Status:  √ Approved  √ Provisional  √ Not-Approved

I certify that the above described supplier has been actively supplying products and/or services for at least 6 months, and their quality performance has been satisfactory. This certification is based on my personal knowledge of the supplier’s performance as reflected in the above over-all rating. Approved by:
Job Title:
Approval Date