Smart Growth for Private Business

Smart Growth for Private Business

Growth is CHANGE.

Growth requires more people, processes and controls.

As a business grows, the structure (organizational chart) has to change. It becomes more complex.

As a business grows, it needs better finance, HR and technology tools

The 5 “P´s"

- PLANNING

- PRIORITZATION

- PACE

- PROCESSES

- PEOPLE

While strategic focus (Planning and Prioritization) and operational excellence (Pace and  Processes) are necessary for growth, they are not sufficient.

Growth also requires the right kind of People, culture and leadership.

Growth requires the hiring, training and retaining of high performance employees, and the building of a high performance management team.

The necessity and power of Processes (Continuous improvement)

The power of processes: the recipes or checklists of how to do something.

Processes reduce delegation risks and mistakes.

Processes must be written down.

After each mistake is corrected, write a process. Apply PDCA role.

Best practices

Learning to live with the humanity of employees—mistakes will happen!

Expect mistakes. Look for them! Find them! Teach and correct!

For control business need daily and weekly measurements.

• Measure: quality; on-time delivery; customer satisfaction; efficiency; daily costs.

Engage employees in writing processes.

Engage employees in measuring key indicators.

Encourage and reward self-reporting of mistakes. Mistakes WILL happen.

What is High Employee Engagement (“HEE”)?

• Employees are emotionally engaged and personally invested in doing great work.
• Employees view their work as more than a paycheck.
• Employees are proud of where they work.
• Employees find meaning and emotional satisfaction in being part of the business.
• Employees find meaning and emotional satisfaction in the purpose of their work.

 The money $$$ is not enough

• It cannot buy long-term, consistent, high employee engagement.

How does it happen?

• Through a combination of culture, values, leadership behaviors, how is treat people—emotionally, financially—and providing an opportunity for them to be all that they can be.
• Do you care about them as people or are they just a means to your end: $$?
• Behaviors count.

HEE—HPO (High Performance Organization)----successful business

Common characteristics of HEE/ high performance companies

1. Employees have a sense of “ownership.”
2. Employees have training and educational opportunities to grow.
3. “Promotion from within” policies.
4. Constant communication about values and standards.
5. Highly accountable, “family” environment.
6. Consistent and fair reward and promotion policies.

Creating a great place to work   apply Culture of “7 E's”: Expectations, Excellence, Employees, Empowerment, Education, Earnings and Execution. 

Source: Edward D. Hess. University of Virginia

Suply Chain and Logistics Maximum Value at Minimum total cost

Supply Chain and Logistics

1. Eliminate all the waste in the fulfillment stream so that only value remains
2. Make customer consumption visible to all members of the fulfilment stream
3. Reduce lead time
4. Create level flow
5. Use pull systems
6. Increase velocity and reduce variation
7. Collaborate and use process discipline
8. Focus on total cost of fulfillment 

Add caption

Total lead time is the sum of all processing time, transit time, and time spent as inventory.

Inbound (supplier) lead time: The amount of time from the point of ordering materials (APIs, raw materials, packaging,..) from a supplier to the point the material is received and available for use.

Manufacturing lead time: The amount of time it takes to send an order to production planning and for the goods to be manufactured and made available for shipping.

Outbound (customer) lead time: The amount of time it takes for a clients order to be received, processed, and shipped to the customer.

Raw material inventory: The amount of inventory that sits as raw material in front of the manufacturing process, measured in average days on hand.

Finished-goods inventory: The amount of inventory that sits in finished goods.

Perfect-order execution

1. Right quantity: How often the rigth quantity of material is sent to the next step in the fulfillment stream.

2. Right product: How often the right product is sent to the next step.

3. Right place:  How often the material is sent to the right place in in the stream.

4. Right time: How often materaisl ase sent on time to the next step.

5. Right quality: How often material is sent with perfect quality to the next step. This includes quality of product and accuracy of information.

6. Right source: How often the materials are sourced from the right supplier.

7. Right price: How often the organization pays the planned price (or cost) for materials.

8. Right service: How often the downstream customer receives expected service.

Productivity= Units Output produced/ Input used
Labor productivity= p.e. 10units per labor hour
Multifactor productivity
Productivity=Output/(Capital€+Labor€+Materials€+Service€+Energy€)
Waste (overproduction, transportation, rework, over-processing, motion, inventory)

Information source: Building a Lean Fulfillment Stream by Robert Martichenko and Kevin von Grade- Lean Interprice Institute


                                                                                                                                                                                                                                      

GMP&continuous improvements (IV)

8. Production and In-Process Controls
Production operations

Raw materials for intermediate and API manufacturing should be weighed or measured under appropriate conditions that do not affect their suitability for use. 

If  a material is subdivided for later use in production operations, the container receiving the material should be suitable and should be so identified.

Critical weighing, measuring, or subdividing operations should be witnessed or subjected to an equivalent control.

Actual yields should be compared with expected yields at designated steps in the production process. Expected yields with appropriate ranges should be established based on previous laboratory, pilot scale, or manufacturing data- Deviations in yield associated with critical process steps should be investigated to determine their impact or potential impact on the resulting quality of affected batches.

Any deviation should be documented and explained. Any critical deviation should be investigated.

The processing status of major units of equipment should be indicated either on the individual units of equipment or by appropriate documentation, computer control systems, or alternative means.

Materials to be reprocessed or reworked should be appropriately controlled to prevent unauthorized use.

Residual materials can be carried over into successive batches of the same intermediate or API if there is adequate control.

Production operations should be conducted in a manner that will prevent contamination of intermediates or APIs by other materials.

In-process Sampling and Controls

Critical in-process controls (and critical process monitoring), including the control points and methods, should be stated in writing and approved by quality unit(s).

In-process controls can be performed by qualified production department personnel and the process adjusted without prior quality units(s) approval if the adjustments are made within pre-established limits approved by the quality unit(s).

Written procedures should describe the sampling methods for in-process materials, intermediates, and API's.

In-process sampling should be conducted using procedures designed to prevent contamination of the sampled material an other intermediates or APIs.

9.Packaging and Identification Labelling of APIs and Intermediates.

There should be written procedures describing the receipt, identification, quarantine, sampling, examination and/or testing and release, and handling of packaging and labelling materials.

Packaging and labelling materials should conform to established specifications. Those that do not comply with such specifications should be reject to prevent their use in operations for which they are unsuitable.

Records should be maintained for each shipment of labels and packaging materials showing receipt, examination, or testing, and whether accepted or rejected.

10. Storage and Distribution

Facilities should be available for the storage of all materials under appropriate conditions. (e.g. controlled temperature and humidity when necessary). Records should be maintained of these conditions if they are critical for the maintenance of material characteristics.

Unless there is an alternative system to prevent the unintentional or unauthorised use of quarantined, rejected, returned, or recalled materials, separate storage areas should be assigned for their temporary storage until the decision as to their use has been taken.

APIs and intermediates should only be released for distribution to third parties after they have been released by quality unit(s).

Perfect-order execution, written correct schedule and procedures to get avoid contamination, wastes and to get Good Manufacturing Practice.

Total lead time is the sum of all processing time, transit time, and time spent as inventory.

Inbound (supplier) lead time: The amount of time from the point of ordering materials (APIs, raw materials, packaging,..) from a supplier to the point the material is received and available for use.

Manufacturing lead time: The amount of time it takes to send an order to production planning and for the goods to be manufactured and made available for shipping.

Outbound (customer) lead time: The amount of time it takes for a clients order to be received, processed, and shipped to the customer.

Raw material inventory: The amount of inventory that sits as raw material in front of the manufacturing process, measured in average days on hand.

Finished-goods inventory: The amount of inventory that sits in finished goods.

GMP&continuous improvements (III)

6. Documentation and records

main points:

All documents related to the manufacture of intermediates or API should be prepared, reviewed, approved and distributed according to written procedures. Such documents can be in paper or electronic form.

The issuance, revision, superseding and withdrawal of all documents should be controlled with maintenance of revision histories.

A procedure should be established for retaining all appropriate documents (e.g.. development, history reports, scale-up reports, technical transfer reports, precess validation reports, training records, procedures records, control records, and distribution records). The retention periods for these documents should be specified.

All production, control, and distribution records should be retained for at last 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed.

Equipment Cleaning and Use Records

Records of major equipment use, cleaning, sensitization and/or sterilization and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment, and the person who performed the cleaning and maintenance.

Records of Raw Materials, Intermediates, API Labelling and Packaging Materials

Master Production Instructions (Master Production and Control Records)

To ensure uniformity from batch to batch, master production instructions for each intermediate and API should be prepared, dated, and signed by one person and independently checked, dated, and signed by a person in the quality unit

Batch Production Records (Batch Production and Control Records)

Batch production records should be prepared for each intermediate and API and should include complete information relating to the production and control of each batch. The batch production record should be checked before issuance to assure  that it is the correct version and a legible accurate reproduction of the appropriate master production instruction.

These records should be numbered with a unique batch or identification number. dated and signed when issued. In continuous production, the product code together with the date and time can serve as the unique identifier until the final number es allocated.

Laboratory Control Records

Laboratory control records should include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays.

Batch Production Record Review

Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labelling, to determine compliance of intermediate or API with established specifications before a batch is released or distributed.

Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed.

All deviation, investigation, and OOS (out of specification) reports should be reviewed as part of the batch record review before batch is released.

7.Materials Management

There will be written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of material.

Manufactures of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.

Materials should be purchased against an agreed specification, from supplier or suppliers approved by quality unit(s).

Upon receipt and before acceptance, each container or grouping of containers of materials should be examined visually for correct labelling, container damage, broken seals and evidence of tampering or contamination. Materials should be held under quarantine until they have been sampled, examined or tested as appropriate, and released for use.

If bulk deliveries are made in non-dedicated tankers, there should be assurance of non-contamination from the tanker.

Large storage containers, and their attendant manifolds, filling and discharge lines should be appropriately identified.

Sampling and Testing of Incoming Production Materials
At least one test to verify the identity of each batch of material should be conducted. A supplier's Certificate of  Analysis can be used in place of performing other test.

Supplier approval should include an evaluation that provides adequate evidence (e.g., past quality history) that the manufacturer can consistently provide material meeting specifications.

Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit whitin the company's control do not need to be tested if the manufacturer's Certificated of Analysis is obtained, showing that this raw materials conform to established specifications. The lack of on-site testing for these materials should be justified and documented.

Samples should be representative of the batch of material from which they are taken. Containers from which samples are withdrawn should be opened carefully and subsequently reclosed.

Storage
Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination.

Materials stored in fiber drums, bags, or boxes should be stored off the floor and, when appropriate suitably spaced to permit cleaning and inspection.

Materials should be stored under conditions and for a period that have no adverse affect on their quality, and should normally be controlled so that the oldest stock is used first.

Certain materials in suitable containers can be stored outdoors, provided identifying labels remain legible and containers are appropriately cleaned before opening and use.

Rejected materials should be identified and controlled under a quarantine system designed to prevent their unauthorised use in manufacturing.

Re-evaluation
Materials should be re-evaluated as appropriate to determine their suitability for use. (e.g., after prolonged storage or exposure to heat or humidity).