Risk assessment of MR department
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | severity | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Severity | Occurrence | Detection | RPN |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Quality Management System & Implementation | External origin standards are not updated | Affects the quality and system | 3 | SC | Lack of checking in the new standards | 3 | Master list of external origin standards to be updated regularly. | Master list of external origin standards are reviewed by MR frequently | 5 | 45 | — | — | — | — | — | — | — |
| Quality Management System & Implementation | Master lists are not maintained properly | Affects the system | 3 | SC | Lack of awareness | 4 | Master lists to be updated regularly. | Master list are reviewed by MR frequently | 4 | 48 | — | — | — | — | — | — | — |
| Quality Management System & Implementation | Unintended use of obsolete documents | Affects the system | 4 | CC | Obsolete documents are not removed from all points of use | 4 | Obsolete documents are identified and seperated | By frequent checking | 5 | 80 | “Obsolete copy” is stamped in all obsolete documents for easy identification | Management Representative | Action taken to be verified after three months | 4 | 3 | 4 | 48 |
| Quality Management System & Implementation | MRM not conducted at regular intervals | Affects the system | 3 | SC | Improper communication | 4 | To follow the MRM plan | Verifying the conduction of MRM periodically | 3 | 36 | — | — | — | — | — | — | — |
| Quality Management System & Implementation | Internal Audits not conducted on time | Quality system failure | 4 | SC | Audit plan not followed | 2 | to follow the audit plan | Review of audit report | 1 | 8 | — | — | — | — | — | — | — |
| Quality Management System & Implementation | Management of change not done | Affect the system | 4 | SC | Lack of awareness | 3 | monitoring in review meetings | by reviewing the minutes of meeting | 3 | 36 | — | — | — | — | — | — | — |
| Quality Management System & Implementation | NCR’s not closed on time | affect the system | 4 | SC | Root cause analysis not done properly | 2 | Updated NCR tracking sheet | periodic review of NCR tracking sheet | 4 | 32 | — | — | — | — | — | — | — |
Risk assessment of HR department
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | sev | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Sev | Occ | Det | RPN |
| Human Resources – Competency | Training not conducted properly | Affects the quality and system | 4 | SC | Improper planning for training | 3 | Training to be planned appropriately and updated in the Annual Training Calendar | Verified by Top management | 4 | 48 | — | — | — | — | — | — | — |
| Human Resources – Competency | Non availability of competent personnel (or) Selecting unskilled personnel | Affects the quality and system | 5 | CC | Competence requirements are not defined for recruitment | 4 | Personnel recruited based on defined competence requirements | Verifying the personnel competence by process heads | 5 | 100 | Competency standard to be defined before the recruitment process | Human Resource personnel | Action taken to be verified after three months | 5 | 3 | 4 | 60 |
| Human Resources – Competency | Decrease in employee efficiency | Affects the delivery | 3 | SC | Improper communication and Employee not motivated | 4 | Motivate the employee through meetings to improve their efficiency | By reviewing the operator efficency reports. | 4 | 48 | — | — | — | — | — | — | — |
| Human Resources – Competency | Updation of Legal and other applicable requirement are not done | Affects the system | 4 | SC | Legal requirements are not checked periodically | 3 | Monitoring the master list of Statutory and Regulatory requirements regularly | Verified by Top management | 5 | 60 | — | — | — | — | — | — | — |
| Human Resources – Competency | Residency not renewed on time | Affects the operations & planning | 4 | SC | not reviewing employee file periodically | 4 | residency to be processed on time | Monitoring of the employee file regularly | 2 | 32 | — | — | — | — | — | — | — |
Risk assessment of Sales
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | sev | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Sev | Occ | Det | RPN |
| Sales | Wrong entry of size designation | Affects the quality | 3 | SC | Type Error | 3 | Reviewing of Customers’ purchase order by Commercial officer | Daily review of SOS order in plan usage | 4 | 36 | — | — | — | — | — | — | — |
| Sales | Order without contract review | Affects the quality and delivery | 4 | SC | Delay in releasing contract review | 3 | Perform contract review as soon as possible once the job is completed | Verified during operations planning | 3 | 36 | — | — | — | — | — | — | — |
| Sales | PSL Level, H2S Level, Material class, Temp not specified in customer PO | Affects the quality | 3 | SC | Customer requirements not clearly identified in the purchase order | 3 | Reviewing of customer purchase order against product requirements by Commercial officer | Review of requirements in Contract Review | 4 | 36 | — | — | — | — | — | — | — |
| Sales | Delivery date committed without proper planning | Affects the Delivery | 4 | SC | Date committed based on Customer requirements | 3 | Review the Customer Requirements against Purchase Order by Commercial officer | During operations planning | 4 | 48 | — | — | — | — | — | — | — |
| Sales | Wrong delivery address | Affects the Delivery | 4 | SC | Type error and destination not reviewed | 2 | Reviewing of delivery information against purchase order before disptach | Review before dispatch | 5 | 40 | — | — | — | — | — | — | — |
| Sales | Delay in invoicing of the job | Affects the cash flow | 2 | SC | commmunation gap | 1 | Communication through proper channel | keep record of all completed jobs in job register | 5 | 10 | — | — | — | — | — | — | — |
| Sales | no proper communication of the customer requirement | Delay in quotation submission | 4 | SC | No proper follow up | 3 | monitoring & follow up of all enquiries | Daily review of enquiry register | 5 | 60 | — | — | — | — | — | — | — |
| Sales | Customer complaints not handled properly | Loss of customer | 4 | SC | poor internal communication | 1 | Communication through proper channel | proper communication to avoid complaints | 2 | 8 | — | — | — | — | — | — | — |
Risk assessment of Design
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | sev | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Sev | Occ | Det | RPN |
| Design | Error in design inputs | Affects the product quality | 4 | SC | Inadequate operating conditions | 3 | Design inputs are to be reviewed based on the customer or standard requirements before performing the process to prevent errors. | During design input review | 4 | 48 | — | — | — | — | — | — | — |
| Design | Inadequate design outputs | Affects the product quality and delivery | 4 | SC | Relevant personnel was not aware about the requirements | 3 | Training to be given to the concerned personnel. | During design output review | 3 | 36 | — | — | — | — | — | — | — |
| Design | Error in drawing | Affects the product quality | 5 | CC | Necessary details not mentioned properly in the drawing | 4 | Verification of the drawing to be done before issue. | During design output review | 5 | 100 | During design output Machine shop Manager shall ensure that adequate details are available in the drawing and to be verified as per given the requirements. | Machine shop Manager | Actions taken verified | 5 | 3 | 4 | 60 |
| Design | Personnel competency | Affects the product quality | 4 | CC | Failure in design | 3 | Training to be given to the concerned personnel. | During design output review | 4 | 48 | — | — | — | — | — | — | — |
| Design | Selection of material | Affect the product integrity | 4 | CC | Product non conformance | 4 | Specifications / MTCs shall be reviewed during the design input | During design input review | 3 | 48 | — | — | — | — | — | — | — |
| Design | Tolerance level not mentioned properly | Affects the product quality | 4 | SC | Human error | 3 | All the design outputs are to be reviewed during design output review based on the inputs and to be verified before approval. | During design output review | 4 | 48 | — | — | — | — | — | — | — |
Risk assessment of Procurement
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | sev | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Sev | Occ | Det | RPN |
| Procurements | Supplier late delivery | Affects the delivery | 3 | SC | Delay in production process (Unavailability of Raw material) | 4 | Some amount of raw material to be maintained in stock | Regular checking of stock list | 3 | 36 | — | — | — | — | — | — | — |
| Procurements | Error in documents provided by the supplier | Affects the quality | 3 | SC | Typo error | 3 | Inform the supplier to prevent typo error | Verify the documents regularly once received from supplier | 4 | 36 | — | — | — | — | — | — | — |
| Procurements | Indent not raised in specified time interval | Delay in Receiving Raw Material. Affects the delivery | 3 | SC | Planning not done properly in Plan visage | 5 | Machine Manager shall provide the requirements to the procurement personnel in advance | During operations planning | 2 | 30 | — | — | — | — | — | — | — |
| Procurements | Quality requirements not specified clearly in the purchase order | Material received with wrong specification. Affects the Quality | 5 | SC | The Person who prepares PO was unaware about the quality requirements | 4 | Monitoring the PO before approval. | Based on the review during approval of PO. | 5 | 100 | Training given to concerned personnel about the quality requirements | Procurement personnel | Action taken to be verified after three months | 5 | 3 | 4 | 60 |
| Procurements | Improper identification of supplier | Affects the quality and delivery | 4 | SC | Supplier performance rating not done periodically due to delay in preparing data (such as delivery time and rejection quantities) | 4 | Updating of such data to be done regularly | Periodic checking of supplier rating | 5 | 80 | Prepare supplier delivery performance and rejection quantity data regularly | Procurement personnel | Action taken to be verified after three months | 4 | 3 | 4 | 48 |
| Procurements | Specification not specified clearly in the purchase order | Delay in Receiving Bought out Items. Affects the delivery | 3 | SC | Item Description not Created as Per Requirement | 4 | Specification should be as per standard requirement. | Before approval of purchase orders, Quality dept. verifies the requirements | 5 | 60 | — | — | — | — | — | — | — |
| Procurements | Supplier evaluation not done prior to purchase of critical goods & services | Reliability of the goods and services | 4 | SC | The goods and services not considered as critical category. | 2 | Critical goods and services are identified. | Critical goods and services are purchased from the list of appoved suppliers only | 2 | 16 | — | — | — | — | — | — | — |
| Procurements | Material not available at regular supplier | affects the planning and delivery | 4 | SC | Dead stock at supplier premises | 3 | To have min 3 suppliers for each items | Master list of suppliers | 3 | 36 | — | — | — | — | — | — | — |
Risk assessment of Operation
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | sev | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Sev | Occ | Det | RPN |
| Operation | Ineffective production plan | Affects delivery | 3 | SC | Improper planning | 3 | Production plan to be prepared effectively in advance. | By verifying Production Plan | 5 | 45 | — | — | — | — | — | — | — |
| Operation | Non Availability of Project Execution Plan | Affects Quality | 3 | SC | Project Process Sequence in is not in Correct Order | 3 | Awareness on Job Training to be given | Project Execution Plan | 5 | 45 | — | — | — | — | — | — | — |
| Operation | Non availability of equipments, tools and inserts | Affects production and delivery | 4 | SC | Periodic checking of tools and inserts used for production are not done. | 3 | Tools and inserts are to be maintained regularly in stock. | By reviewing required tool and inserts | 3 | 36 | — | — | — | — | — | — | — |
| Operation | Non availability of raw material | Affects production and delivery | 3 | SC | Material not available in stock | 4 | Some quantity of Materials are to be maintained in stocks. | By reviewing the stock list. | 4 | 48 | — | — | — | — | — | — | — |
| Operation | Internal non-conformance | Affects quality and delivery | 5 | CC | Requirements are not addressed properly in the daily production control sheet | 4 | Ensure that the requirements are to be addressed properly | By reviewing through in-process inspection | 4 | 80 | Verification of the Production control sheet by the Quality Engineer for the proper addressing of the requirements before the issue of the documents | Quality Engineer | Action taken to be verified after three months | 5 | 3 | 3 | 45 |
| Operation | Improper handling | Affects the quality | 4 | SC | Unskilled person | 3 | Training to be given for concerned personnel | By monitoring the personnel | 3 | 36 | — | — | — | — | — | — | — |
| Operation | Emergency requirement for any product / item | Difficulty in purchasing the items | 3 | SC | Improper planning | 2 | Minimum 3 supplier for the critical items to be identified | By verifying the Approved supplier list | 4 | 24 | — | — | — | — | — | — | — |
| Operation | Employee performance reduced (or) Not competent enough to perform a new activity. | Affects the quality and timely delivery | 3 | SC | Adequate training not provided | 3 | Required training to perform the job to be given for concerned personnels | Training Matrix | 4 | 36 | — | — | — | — | — | — | — |
| Operation | Shortage of work/office space inside our facility | Affects work | 2 | – | Adequate space not available. | 3 | Proper layout for the work space to be designed | By verifying layout | 3 | 18 | – | – | – | – | – | – | – |
| Operation | Requirement for changing of shifts | Affects the routine activities | 4 | SC | Improper planning | 3 | Required shifts to be arranged | By Production monitoring | 3 | 36 | – | – | – | – | – | – | – |
| Operation | Working hours affected due to Ramadan | Affects the timely delivery | 4 | SC | Improper planning | 3 | Proper planning to be done prior start of the job | By verifying production plan | 1 | 12 | — | — | — | — | — | — | — |
| Operation | Not enough knowledge to perform the operations | Quality of the work will be affected. | 4 | SC | Incompetent personnel on the job | 3 | Training to be given for concerned personnel | Skill competency matrix | 3 | 36 | — | — | — | — | — | — | — |
| Operation | Difficulty in identifying the parts of the assembly product in dismantled condition | Affects the product quality & delivery | 4 | SC | Part identification number not visible on the sub assembly parts | 3 | Identification tagging to be maintained throughout the processes with reference to production plan/Job Number | Identification on each item by either SRV # or Job # | 4 | 48 | — | — | — | — | — | — | — |
| Operation | Products damaged due to improper handling (within the facility / while transporting to the customer) | Affects the product quality | 4 | SC | Improper Handling of the material | 3 | Proper protection for critical components to be provided | By verifying at the time of dispatch | 3 | 36 | — | — | — | — | — | — | — |
| Operation | Unexpected Power cuts | Affects the delivery | 1 | – | Ministry issue | 1 | Alternate power source to be made available | Requested for alternate power source arrangement | 2 | 2 | — | — | — | — | — | — | — |
| Operation | Errors identified in the Manufacturer provided features. | Affects the customer satisfaction | 4 | SC | Poor quality of products delivered by manufacturers | 3 | Supplier evaluation needs to be conducted periodically | By supplier evaluation | 3 | 36 | — | — | — | — | — | — | — |
| Operation | Prodctivity effects due to Covid -19 pandamic | Affect the quality & delivery | 4 | SC | COVID -19 Pendamic | 4 | Work from Home for the personnel who can manage from home | Additional resposibility & authority to be proded to on site personnel | 1 | 16 | — | — | — | — | — | — | — |
Risk assessment of Maintenance
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | sev | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Sev | Occ | Det | RPN |
| Maintenance | Periodic maintenance not done | Affects cost and delivery | 3 | SC | Carelessness of the operator | 3 | Proper preventive maintenance shall be done as per the plan | Frequent checking to be done | 3 | 27 | — | — | — | — | — | — | — |
| Maintenance | Delay in completion of break down | Affects cost and delivery | 4 | SC | Non availability of spares | 4 | Maintaining minimum stock (spare parts) in store | Checking with break down register | 5 | 80 | Critical spares shall be identified and maintained in stock | Machine shop Manager | Action taken to be verified after three months | 4 | 3 | 4 | 48 |
| Maintenance | Delay in preventive maintenance | Affects cost and delivery | 4 | SC | Preventive maintenance schedule not followed | 4 | Preventive maintenance to be done as per the schedule | Frequent checking to be done | 3 | 48 | — | — | — | — | — | — | — |
| Maintenance | Improper preventive maintenance | Affects cost and delivery | 3 | SC | Checklists prepared are inappropriate to the machine to be maintained | 3 | Checklists are to be prepared as per the manufacturer’s specification | Checking with Manufacturer’s specification | 5 | 45 | — | — | — | — | — | — | — |
| Maintenance | Incompetent personnel | Affects quality & cost | 4 | SC | Selection criteria not defined | 3 | Skill competency matrix prepared | Review of training effectiveness | 3 | 36 | — | — | — | — | — | — | — |
| Maintenance | Delay in availability of machines spares | Affects cost and delivery | 4 | SC | non availability of spares locally | 3 | Plan to have spares in stock | Review of the suppliers list | 4 | 48 | — | — | — | — | — | — | — |
| Maintenance | Non availability of support from the manufacturer of the machine | affects cost and delivery | 4 | SC | Authorised services of manufacturer is not available locally | 4 | Outsourcing the service | Communication with service providers | 2 | 32 | — | — | — | — | — | — | — |
Risk assessment of Quality Control
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | sev | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Sev | Occ | Det | RPN |
| Quality Control/ Quality Assurance | Indication found in Mill TC | Affects the quality | 4 | SC | Typo error | 3 | Inform the supplier to prevent typo error while preparing Mill TC | By checking MTC during incoming inspection | 4 | 48 | — | — | — | — | — | — | — |
| Quality Control/ Quality Assurance | Instrument error | Affects the quality | 5 | SC | Improper handling of the instuments | 4 | Training to be given to conerned personnel about instrument handling | Monitor the personnel while handling the instruments | 4 | 80 | Instrument to be sent for calibration. Out of calibration requirements to be ensured. | QA/QC Engineer | Action taken to be verified after three months | 5 | 3 | 3 | 45 |
| Quality Control/ Quality Assurance | Some instruments are not calibrated beyond due date | Affects the quality | 3 | SC | Calibration plan not updated | 3 | Calibration due date to be checked by concerned personnel regularly | Using calibration plan | 4 | 36 | — | — | — | — | — | — | — |
| Quality Control/Quality Control/ Quality Assurance | Difficulty in identifying the material | Affects the system and quality | 4 | SC | Identification tag not tied on the product | 3 | Identification tag is tied after the completion of process. | By verifying visually | 3 | 36 | — | — | — | — | — | — | — |
| Quality Control/ Quality Assurance | Improper identification and traceability | Affects the system | 4 | SC | Identification number not replaced when damaged | 3 | Identification number properly replaced when it is found damaged | Monitored regularly by Concerned personnel | 4 | 48 | — | — | — | — | — | — | — |
| Quality Control/Quality Control/ Quality Assurance | Delivery of Non-conforming products | Customer dissatisfaction | 5 | CC | Final inspection not performed prior dispatch | 3 | Final inspection is performed by the QC Engineer prior to dispatch | Using Production and quality plan | 2 | 30 | Products to be called back and assessed as per control of NC products. | QA/QC Engineer | Action taken to be verified after three months | 5 | 1 | 2 | 10 |
| Quality Control/ Quality Assurance | Wrong material taken for the production | Product nonconformity | 5 | CC | identification of the material not done properly | 3 | Color code is assigned for the materials. | By verifying color code & traceability of the material prior to use. | 2 | 30 | Precautions shall be taken to prevent such errors by verification of the traceability before use. | QA/QC Engineer | Action taken to be verified after three months | 5 | 1 | 2 | 10 |
| Quality Control/ Quality Assurance | Incompetent personnel | Affect quality of the product | 4 | SC | No proper training provided to the personnel | 3 | Training matrix is prepared | By verifying the effectiveness of the training | 2 | 24 | — | — | — | — | — | — | — |
Risk assessment of Store
| Process Function | Potential Failure Mode | Potential Effect(s) of Failures | sev | Class | Potential Cause(s)/Mechanism(s) of Failures | Occur | Current Process Controls Prevention | Current Process Controls Detection | Detect | RPN | Recommended Action(s) | Responsibility & Target Completion Date | Action Taken | Sev | Occ | Det | RPN |
| Store | Material received without Supplier Invoice | Affects the system | 3 | SC | Supplier unawareness | 3 | Inform the supplier to provide invoice | When receiving material | 4 | 36 | — | — | — | — | — | — | — |
| Store | Wrong entry of Part No. / heat code | Affects the system and quality | 3 | SC | Human error / Typo error | 3 | Create awareness about the importance of this activity | Check the store issue and receiving records | 5 | 45 | — | — | — | — | — | — | — |
| Store | Rust formation on machined part | Affects the quality | 4 | SC | Rust preventive oil not applied / exposed to moisture | 4 | Rust preventive oil applied and stored after machining | Visual Inspection during cycle count | 5 | 80 | Instruction given to the concerned personnel about the rust prevention methods | QA/QC Engineer / Stores Incharge | Action taken to be verified after three months | 4 | 3 | 4 | 48 |
| Store | Exposed Sealing surfaces damages | Affects the quality | 3 | SC | Improper preservation | 2 | Stored in a separate area to prevent damages | Regularly | 6 | 36 | — | — | — | — | — | — | — |
| Store | Delivery note issued to customer with wrong information | Customer dissatisfaction | 4 | SC | no proper information | 2 | store receipt voucher is prepared to identify the received items | store receipt voucher is prepared to identify the received items & verified by QA/QC | 4 | 32 | — | — | — | — | — | — | — |
| Store | Unexpected Power cuts | Affects the quallity | 2 | – | Ministry issue | 1 | Alternate power source to be made available | Requested for alternate power source arrangement | 3 | 6 | — | — | — | — | — | — | — |
| Store | Wrong shipment done to the customer | Customer dissatisfaction | 4 | SC | Communication Gap | 1 | Proper communication to be done through proper channel | store keeper to ensure the correct information is taken for the shipment | 3 | 12 | — | — | — | — | — | — | — |
Dear Mr. Pretesh Biswas,
I really thank you for this Risk Assessment example sheet shared, mainly the M.R. where many industries skip or unaware of the Risk assessment of M.R. itself. I appreciate your devotion in this field.
With Best Regards, Shankar Ghosh
Thanks.