Requirements to Set up a manufacturing Facility- As understood by a novice with empirical knowledge only

Hello everybody

I am writing after a hiatus of almost 2 years!! Nevertheless, here I am, still alive and kicking!!!!

The stuff I am posting here is from a presentation I put together for a friend recently on his query regarding points to be considered in setting up a manufacturing utility for some electronic gadget. I know this is not exhaustive material by any measure, but it definitely gave me a chance to refresh my head on the issue at hand. So here goes.. Please feel free to append more information you may have.

Step 1 Company Induction

• Form a company
• Register the company under Company’s Act
• Obtain CST, State ST, IT registrations
  

Step 2 License to Manufacture

• Obtain the License for the company to manufacture from the appropriate ministry

Step 3 Product Study

• National market/ International Market?
• Projected demand
• Are there existing manufacturing units?
• If yes, what is the current combined manufacturing capacity of existing units?
• What is the expected manufacturing capacity of the proposed manufacturing facility?

Step 4 Inputs Designer- Design Transfer Documentation

• Costed Bill of Material- CBOM (Item tech. specification, )Vendor info for each item, cost based on lot size
• Gerber file readable by commonly used s/w (PCB final design)
• Autocad drawings of all mechanical parts with info of color, dimension, material used, commercial name of material etc.
• Acceptance criteria for all items on CBOM, method of testing, AQL- including any test reports from vendors, approval certificates from vendors etc., quality plan
• Manufacturing flowchart, detailed work instructions, test plans, testing procedures, test report outlines
• Ideally a work time study of per unit production

Step 5-Identification

• Identify the step by step operations to be performed in manufacturing per unit of the product
• Identify machinery required for manufacturing operations along with any machine specific software required
• Identify skill set/experience required for manufacturing operations
• Empirical work time study and machine capacity to find out the optimum number of personnel per operation, no. of identical machinery required etc.

Step 6- Real Estate Requirements

• Total land area requirement depends on the complete set of manufacturing operations to be performed and also support operations (Doesthis include warehousing?)
• Consider size and number of machinery to be installed (minimum distance between subsequent operations to reduce delay due to material movement)
• Consider proximity to raw material sourcing/ transport- closeness to port/rail yard etc.

Step 7-Hardware/ Software Requirements

• Hardware includes computer terminals, machinery
• Software includes basic computer software for administration and specialized software required for automated machinery ( Ex. Pick and Place machinery for PCB, software for reading Gerbers, Autocad file inputs etc.)

Step 8- Power/ Water Requirements

• Work out total power required per full running shift of manufacturing facility and calculate Electricity requirements
• Calculate water requirement and needs to arrange for auxiliary sources if need be
• Very importantly set up ESD safety Earth connection points

Machinery Selection

• Ensure that the total production capacity if the machinery is in agreement with the projected production requirement – Investing in a higher capacity machinery right away causes reduced machine efficiency and also unnecessary consumption of power
• Ensure that machinery is a tested and proven model as against newer models

Work- Time Study

• Required to ensure that there are no bottlenecks in the production assembly line
• This is done by taking into consideration the time taken for each step in the production process
• Steps that take more time to perform are done by having more personnel parallely make more units
• Steps that take lesser time to perform are done by fewer personnel

QA/QC Operations

• Ensure vendors are established in their products and can supply Quality checked OK reports, safety certificates etc.
• Ensure that Inventory Receiving facility is supplied with correct Quality criteria to check incoming inventory and accept them based on AQL
• Ensure that minimum Quality check points are established in the production assembly line

Establish a Process based System

• Documentation Control and Records control
• Inventory Control
• Human Resource management and Training
• Purchase control
• Equipment maintenance
• Product Identification and traceability
• Handling, storage, Packaging, Storage and Delivery
• Control of Limited Shelf Life Parts
• Control of Monitoring and Measuring Equipment
• Monitoring and Measurement of Products
• Control of Non-conforming Products
• Corrective and Preventive Actions

Document Control

• Identification means to differentiate for Internal and External Documents
• Master List of documents
• Distribution control of documents
• Change control of documents
• Control of obsolete documents
• Authority for all of above processes

Control of Records

• Identification of required Records
• Templates for records (If repetitive process outcomes are recorded) and their distribution control
• Training for creating and maintaining records
• Authorisation of records
• Identification, Storage and Retrieval of records
• Destruction of obsolete records

Equipment Maintenance

• Identification for all equipment including

Internal Equipment ID (If any)
Manufacturer
Purchase proof No. (if any)
Model No.

• Whether any calibration/periodic servicing Required
• Whether calibration/service is internal/External
• Date of Last Service
• Details of Calibration/service done with a certificate and Report to be maintained
• If equipment is under repair, means of quarantining and identification needed
• If equipment is portable, suitable means for transporting to be followed to ensure that intended use of the equipment is not affected
• Calibration activities to be carried out in prompt manner and traceable to national or international standards
• If equipment is under repair, means of quarantining and identification needed
• If equipment is portable, suitable means for transporting to be followed to ensure that intended use of the equipment is not affected

Identification and Traceability

• Method of identifying parts, sub-assemblies and assemblies to be established
• Identification must be maintained right from purchasing, storage, release to production, assembly, testing, release to warehousing and in all records generated in the interim
• Training to personnel for understanding and using such identification should be provided and evaluated

Handling, Packaging, Storage and Delivery

• Methods for handling parts, assemblies, sub assemblies, packaged goods, measuring equipment etc. to be established
• Provisions like trolleys, gravity-based conveyance of products to be made for movement of goods and materials
• Storage conditions for raw materials of different types to be determined and arranged for
• Packaging standards should be adhered to
• All specifications for packaging materials including drawings, master samples and material specifications to be maintained by the Engg. Department
• Any final Quality check operations before delivery including AQL should be defined and adhered to- Records to be maintained

Control of Limited Shelf life Parts

• Identify shelf life of all purchased raw materials
• Record shelf life alongside during storage
• Storage conditions to be maintained as per manufacturer recommendation
• Stores should release parts on a FIFO (First In-First Out) basis
• Clear Directions on disposal of Products with expired shelf life to be documented and adhered to

Control of Monitoring and Measuring Equipment

• Identification including

Internal Equipment ID (If any)
Manufacturer
Purchase proof No. (if any)
Model No.

• Whether any calibration/periodic servicing Required
• Whether calibration/service is internal/External
• Date of Last Service
• Master list of such equipment to be maintained
• Details of Calibration/service done with a certificate and Report to be maintained

Monitoring and Measurement of Products

• Identify stages at which product should be tested (sub assembly/ sub assembly/ final etc.)
• Method of testing to be established and documented
• Acceptance Criteria and Acceptable and unacceptable results of testing to be demarcated and testing personnel trained to identify the same
• Acceptable Quality level in case of lot testing should be determined

Control of Non-conforming Products

• Products (sub assemblies/ assemblies/ final products) Tested OK and Not OK should be clearly identified and segregated
• Non- conforming product handling should be clearly defined and documented and adequate training provided (Accept with concession/ Repair/ Rework/ Scrap)
• Non- conforming product handling should be adhered to and proper records of any repair/rework maintained to avoid inadvertent supply of faulty product to customer

Corrective and Preventive Actions

• Product corrective actions and system corrective actions to be identified clearly
• Product fault conditions/method of identifying the existance of fault and the corrective action to be taken should be clearly document and personnel should be trained
• All corrected products should be thoroughly retested and certified OK by authorised signatory and corrective action records maintained
• System corrective actions to be implemented by authorised personnel
• Performance of system to be checked after corrective action and adequate updates to procedures and work instructions made and distributed accordingly
• Preventive Actions to be implemented by authorised personnel
• Documentation of the preventive action, expected outcome and any contra-indications expected
• Preventive action to be implemented on full scale only after a successful trial run
• Adequate records to be maintained

Human Resource Management and Training and Evaluation

• Identification of personnel required- skill set, experience, No.
• Method of personnel evaluation- written testing, interpersonal interviews, hands-on testing
• Evaluators- thrid party consultants/ SME/s?
• Maintenance of hired personnel records
• Maintenance of skill matrix for constant updating
• Regular evaluation of personnel (Evaluation indices to be identified and documented)
• Regular training areas to be identified and training provided, documented and personnel evaluated for level of benefit derived from training
• Modes of training ro be identified( class room/field trip/ hands-on?)

Example: In case of manual assembly operations, an adept should train the semi-skilled work force in their respective operations, and evaluate them after a brief practice period and certify them fit for production assembly

• Periodic evaluation is necessary
• Similarly, in case of new machinery being deployed, personnel should be trained by representative of machinery manufacturer and then certified fit for operating the machinery