Updating a Quality Management System for a Mexican Industrial Organization: Case Study
Abstract
:1. Introduction
2. Updating Empirical Quality Management Systems
3. Methods: Case study
Study Objectives and Procedures
4. Results and Discussion
4.1. Identifying Processes and SWOT Analyses
4.2. Evaluation of the Current QMS Status within the Integration Area
4.3. Evaluation of the Current Processes in the Area Against the Existing QMS Documentation
4.4. Updating the Process Documentation That Impacts the Integration Area
4.5. Definition of Markers for the Integration Area Processes
- Client satisfaction: The integration area is in charge of delivering the product to the client and, thus, has an optimum position to evaluate the project developed.
- Adding components to the project: This marker intends to evaluate the purchasing area and warehouse, which have the responsible staff to provide all the supplies (components) to carry out the project. Commonly, many components exceed or, even worse, are lacking; thus, in both cases, waste happens.
- Parts received with late delivery: This marker intends to evaluate delivery dates from the machining area to the integration area compared to the date met for the total delivery of the parts per project. Thus, delays in the final delivery date are evident.
- Reworks: Allows identifying the percentage of reworks performed per project and also its responsible process.
4.6. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Process | Activities | Responsible |
---|---|---|
Assembling |
| Integration Area Supervisor |
Control |
| Integration Area Manager |
Programming |
| Programming Supervisor |
Management |
| Integration Area Supervisor |
Strengths | Opportunities |
---|---|
|
|
Weaknesses | Threats |
|
|
QUALITY MANAGEMENT SYSTEM DIAGNOSTIC ASSESSMENT ISO 9001- 2015 INTERNATIONAL QUALITY NORM | |||||
GRADING CRITERIA: A. Complete compliance (5 points: Established, Implemented, and Maintained); B. Partial compliance (3 points: Established, Implemented, Not maintained); C. Minimal compliance (1 point: Established, Not implemented, Not maintained; Corresponds to identification and system planning stages); D. Noncompliance (0 points: Not established, Not implemented, Not maintained N/S). | |||||
No. | NUMERALS | GRADING CRITERIA | |||
A | B | C | N/S | ||
4. AREA CONTEXT 4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT | |||||
1 | Pertinent external and internal matters are determined by the purpose and strategic direction of the area. | 1 | |||
2 | A follow-up and information review are performed on the external and internal matters. | 0 | |||
4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF THE PARTIES INTERESTED | |||||
3 | The parties interested and their requirements for the QMS have been determined. | 1 | |||
4 | The follow-up and information revision of the parties interested and their requirements were performed. | 0 | |||
4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM WITHIN THE AREA | |||||
5 | The QMS scope has been determined according to operational processes, products and services, physical installations, and geographical location. | 3 | |||
6 | Has the QMS scope been determined taking into account the external and internal problems, parties interested, and their production and services? | 3 | |||
7 | The QMS system has documentation available and within reach. | 5 | |||
8 | The requirements (exclusions or not applicable) are justified and/or documented as non-applicable for the QMS. | 3 | |||
4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES | |||||
9 | The necessary processes are identified for the organizational QMS. | 3 | |||
10 | The process management criteria are established for their management, taking into account the responsibilities, procedures, control measurements, and necessary performance markers that allow their effective control and operations. | 1 | |||
11 | Documented data that supports the operations of these processes are kept and maintained. | 3 | |||
SUBTOTAL | 5 | 15 | 3 | 0 | |
Structure Value: % Obtained ((A+B+C)/100) | 42% |
Norm Number | Compliance Percentage | |
---|---|---|
4 | Area context | 42% |
5 | Leadership | 50% |
6 | Planification | 10% |
8 | Operation | 55% |
9 | Performance evaluation | 27% |
10 | Improvement | 18% |
Total | 34% |
Process or Activity | Status within the QMS | Cause |
---|---|---|
1. Assembling | Not updated | The process suffered changes due to the working method’s evolution |
| New activity | Already performed without formality and has never been documented |
| New activity | Performed, but without formality, and has never been documented |
2. Control | Lack of updating | The process suffered changes due to the working method’s evolution |
| New activity | Already performed without formality and has never been documented |
| New activity | Already performed without formality and has never been documented |
| New activity | Already performed without formality and has never been documented |
3. Programming | Lack of updating | The process suffered changes due to the working method’s evolution |
| New activity | Already performed but without formality and has never been documented |
4. Management | Updated process | The process has not been documented |
| New activity | Already performed, but with no formality, and has never been documented |
Process or Working Instruction | Code | Result |
---|---|---|
Assembling process | PRI-PR-10 | Updating process |
Working instructions for reworks | SOP-10-02 | New document |
Working instructions to request consumables from the warehouse | SOP-10-03 | New document |
Control process | PRI-PR-09 | Updated |
Working instructions for electric diagrams | SOP-09-01 | New document |
Working instructions for manuals | SOP-09-02 | New document |
Programming process | PRI-PR-11 | Process updated |
Management process | PRI-PR-12 | New document |
Flow management of electronic components | PRI-PR-12-01 | New document |
Flow management of machined parts | PRI-PR-12-02 | New document |
Working instructions for screws | SOP-12-01 | New document |
Working instructions for project support and release | SOP-12-02 | New document |
Process | Activities |
---|---|
Assembling |
|
Control |
|
Programming |
|
Management |
|
ASSEMBLING PROCEDURE | Page: 3 of 4 | |||
Revision: 8 | ||||
Norm ISO 9001:2015: 8.5.1 Reference | Code: PRI-PR-10 | |||
ACTIVITY | NAME | POST | SIGNATURE | DATE |
Made by: | Assembler | 28-nov-20xx | ||
Authorized | Manager | 28-nov-20xx | ||
CHANGE CONTROL | ||||
Number of revisions affected | Date when the change was proposed | Chapter or subindex modified | Change description | |
0 | 07-febrero-20xx | NA | Document made | |
1 | 15-August-20xx | 5.1 | 5.1 Caption added: “This activity allows validating the design authorized by the client”. | |
4.2 | 4.2 The PRI-PR-02 was added as a reference document. | |||
6 | 6. The order format and finished assemblage (PRI-PR:10F01) were modified. | |||
2 | 15-February-20xx | NA | Xxxx is assigned as the Responsible person for the procedure. | |
3 | 19-June-20xx | NA | Documented information was restructured by transitioning to the 2015 version, and xxxx is in charge of procedures. | |
4 | 20-June-20xx | NA | xxxx is assigned to be in charge of procedures. | |
5.3 | Mail is added as a purchase requisition option. | |||
5.4 | Mail is added as a purchase requisition option. | |||
5 | 16-July-20xx | 4 | Point 4.3 of SOP-IT-02 is added as a reference. | |
NA | Procedure xxxx is assigned to the person in charge. | |||
5 | Point 5. Policies are restructured as a whole. | |||
6 | 30-July-20xx | 5.6 | Institutional mail is now the official communication medium in the Projects in Integration Process folder. | |
7 | 28-Nov-20xx | 5.8 | Waste instructions for residuals are added. | |
8 | 21-Nov-20xx | 5.3 | Documentation process is updated in general. |
Marker Name | Metrics | Formula | Evaluation Ranges | ||
---|---|---|---|---|---|
Client satisfaction per project | Requirement satisfaction | Comply | Partially comply | Non- compliant | |
Delivery date satisfaction | Comply | Partially comply | Non- compliant | ||
Satisfaction with the attention offered | Comply | Partially comply | Non- compliant | ||
Components added to the project | Total components added | >1 <3 | > 3 < 5 | > 5 | |
Parts received with late delivery | Percentage of parts with late delivery | <3% | > 3% < 10% | > 10% | |
Reworks | Percentage of reworked parts | <3% | > 3% < 10% | > 10% |
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López-Figueroa, J.C.; Lagarda-Leyva, E.A.; Fornés-Rivera, R.D.; Bueno-Solano, A. Updating a Quality Management System for a Mexican Industrial Organization: Case Study. Businesses 2024, 4, 39-52. https://doi.org/10.3390/businesses4010003
López-Figueroa JC, Lagarda-Leyva EA, Fornés-Rivera RD, Bueno-Solano A. Updating a Quality Management System for a Mexican Industrial Organization: Case Study. Businesses. 2024; 4(1):39-52. https://doi.org/10.3390/businesses4010003
Chicago/Turabian StyleLópez-Figueroa, Julio César, Ernesto A. Lagarda-Leyva, René Daniel Fornés-Rivera, and Alfredo Bueno-Solano. 2024. "Updating a Quality Management System for a Mexican Industrial Organization: Case Study" Businesses 4, no. 1: 39-52. https://doi.org/10.3390/businesses4010003
APA StyleLópez-Figueroa, J. C., Lagarda-Leyva, E. A., Fornés-Rivera, R. D., & Bueno-Solano, A. (2024). Updating a Quality Management System for a Mexican Industrial Organization: Case Study. Businesses, 4(1), 39-52. https://doi.org/10.3390/businesses4010003