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 Planning stage | 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 | Indent not raised in the specified time interval | 5 | SC | Material received with the wrong specification. Affects the Quality | 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 | The Person who prepares PO was unaware of the quality requirements | 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 | The specification should be as per standard requirements. | 3 | SC | Item Description not Created as Per Requirement | 4 | Delay in Receiving Bought Out Items. Affects the delivery | Before approval of purchase orders, Quality dept. verifies the requirements | 5 | 60 | — | — | — | — | — | — | — |
| Procurements | Supplier performance rating is not done periodically due to delay in preparing data (such as delivery time and rejection quantities) | Reliability of the goods and services | 4 | SC | Supplier evaluation not done before purchase of critical goods & services | 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 | The goods and services are not considered as critical category. | 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 | Productivity effects due to Climate change | Affect the quality & delivery | 4 | SC | Additional responsibility & authority to be provided to on-site personnel | 4 | Identify contingency plan to mitigate climate change by identifying alternated production site | Additional responsibility & authority to be provided 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.
Dear Mr. Pretesh Biswas,
Thank you very much for your sample sheet of Risk Asessment. Could yo please help explain define initial words at the head of each form