Development of a Company

Wide Plan for Learning,

Training and Cross-Training

Action Learning Team C

Erin Smyth

Esmeralda Karajic

Corinne Dekker

Introduction

Description of the Organization:

A small pharmaceutical company called Biotech Pharmaceuticals

produces raw materials, intermediates and final drug products. They

currently have over 200 employees and are still growing. They have

new clients that want new products to be produced, therefore, they need

to hire more employees. They need a more effective training program

for the production and quality control chemists they need to hire.

Management Structure:

President, vice president, chief financial officer, director of quality

control, director of production, supervisors of quality control and

production. On each shift there is quality control chemists and

production workers, along with a team lead for each group.

Problem Statement

Problem Statement:

Currently there is no standardized program or

documentation for the training of new and existing

employees.

Goal Statement:

Create a standardized training program that allows all

individuals to be in sync with their training and tasks, in

order to be more effective in their job and the company

to be more productive.

The Problem

• With growth of the company and influx of new people,

new employees are leaving the current training

program with inconsistent training.

• Training is being performed by different individuals

each time whom are not necessarily qualified.

• Training is not standardized, learning different

procedures and methods.

• Standard Operating Procedures (SOPs) exist but are not

being used in training and some are outdated, need to

be revised to accommodate new procedures and

equipment.

The Problem

• Experienced staff have to re-train employees leading to a

less production shift.

• Level of drug production is down and overall employee

morale and contentment is low.

• Training currently is not falling under the guidelines set by

Health Canada.

• No back-up plan exists when employees on a shift are sick

or on vacation.

• Currently they get people in for overtime, however, this is

not cost-effective.

Issues Explored

1. How will the company benefit if Standard Operating

Procedures (SOPs) and qualified trainers are used?

2. What are the strengths, weaknesses, opportunities and threats

(SWOT) of cross-training and Standard Operating Procedures

(SOPs)?

3. How will this new training program allow new employees to

feel that they are prepared for their job and increase their job

performance overall?

Benefits of Using SOPs in

Training

•Proper training starts with procedures that clearly demonstrate the task at

hand and ensures that everyone is trained the same way if they follow the

Standard Operating Procedures (SOPs).

•This will “ensure that processes and activities occur as they should, so

that they yield the same results every time” (Gough and Hamrell, 2009, p.

70).

•SOPs accomplish standardization when performing tasks and thus

ensuring the accuracy and precision of results and products produced

(Akyar, 2012, p. 369).

•They improve job performance by reducing the number of mistakes that

will be made thus ensuring quality and compliance (Brewton, Culbreth &

Groger, 2011, p. 27).

Benefits of Using SOPs in Training

• Biotech Pharmaceuticals is regulated by Health Canada, therefore, Standard

Operating Procedures (SOPs) are the first line of defense against an audit.

They guarantee that procedures are being followed in a certain way and that

training will be carried out in a certain manner (Schniepp, 2011. p. 70).

• “SOPs can be created as a training document to teach about a particular

process or to define what is needed to be done for training” (Akyar, 2012, p.

374).

• It is necessary that SOPs are being used in training but that they are current,

not outdated and revised when new procedures or equipment are

implemented (Akyar, 2012, p. 374).

• They decrease work effort for employees, as well as, “addressing safety

concerns by providing information for individuals to perform their jobs

safely” (Akyar, 2012, p. 374).

Benefits to Using Qualified Trainers

• Qualified trainers should be Subject Matter Experts (SME) and have 2-3 years

of experience in order to effectively train employees (Compliance Insight Inc,

2012, p. 7).

• Qualified trainers will pass on their expertise and experience, they will ensure

consistency in the training, and not pass on bad habits or misunderstandings

(Illeris, 2011, p. 78).

• Important that trainers are properly qualified as an auditor may notice repeated

errors in an analyst results, and look up the employees training records, as well

as, the trainers records to determine if the trainer was qualified (Sims, 2013).

• Currently, training is being done by different personal and Standard Operating

Procedure (SOPs) are not being used, so new employees are not getting

consistent training.

• Ensuring that SOPs are used in training will lead to standardization on

procedures, assuring that employees perform the tasks the same each time.

Benefits to Using Qualified Trainers

• Trainers with extensive experience will be able to perform procedures

efficiently and quickly, as well as, have tips for problem solving various issues

that come up.

• Poor trainers will have issues such as; lack of experience or knowledge, poor

speaking abilities or nervousness, all leading to an ineffective training program

(Compliance Insight Inc, 2012, p. 11).

• A qualified trainer is expected to be knowledgably, possess excellent

communication skills and be able to communicate at the level and language of

the participants (Bringslimark, 2004, p. 46).

• Internal employees would be more beneficial as trainers as they already know

the operations and procedures of the company so they are already Subject

Matter Experts (SME), as well should have at least 2-3 years experience at the

company (Compliance Insight Inc, 2012, p. 7).

Strengths of Cross-Training and SOPs

• Cross-training is an effective way in making sure business continues to run

while an employee is away on vacation, off sick or leaves the company.

• Also, a great way of promoting employees to be trained for different skill sets.

• Standard Operating Procedures (SOPs) are important for efficiency of

operations, quality control of the company, and regulatory compliance.

• Provides employees with practical and understandable information that enables

safe and efficient job performance.

• Provides a clear view of existing knowledge gaps and potential inefficiencies

caused by inadequate training.

• SOPs will be used in the cross-training to ensure employees are learning

procedures in a standardized manner. As well, provide a set of instructions for

employees filling in on jobs they do not regularly perform, so it is essential for

them to be well written and clear (Akylar, 2012, p. 374).

Weaknesses of Cross-Training and

SOPs

• Cross-training can as well be a weakness to both the company and employee, as

it is those who feel insecure in regards to their job security that can diminish the

training program by resisting sharing knowledge and skills because of

competition. Danielson (2000) identifies this weakness with cross-training in his

case study where “perhaps the greatest change is that workers may be idle when

there are no jobs to complete, not when there are no jobs that particular workers

can complete” (p.5).

• If employees feel that they might lose their jobs because of cross-training they

might rebel against the training, whether through not sharing proper information

while training another employee or just choosing not to participate at all in the

process

• If the company violates any of the regulatory compliance requirements it is

issued a Warning Letter. The company is then required to correct compliance

violations and implement procedures to prevent them from occurring in the

future.

Opportunities of Cross-Training and

SOPs

• As mentioned being indispensable and fear of losing one’s job is

the greatest weakness that employees face and it is very

important that Biotech Pharmaceuticals make it clear that the

organization “values people’s ability to support each other and

that single points of failure are a company-wide weakness”

(Cancialosi, 2014).

• SOPs can bring opportunities for Biotech Pharmaceuticals in the

area of supporting its employees with knowledge to perform

their job functions adequately, (Peterson, 2006, p.2) along with

the ability to update the technology used to apply these manuals.

With the internet based technology the SOPs can “cut through

the fog created by pages of written explanations”.

Threats of Cross-Training and

SOP • Most will fight back on having such a training program put in

place and as a result slow down the training process if their

influence on negativity of this program reaches the rest of the

groups.

• If SOPs are not followed properly by the company it can result in

financial vulnerability resulting from operational inefficiency

and with the compromised product quality it can result in

“product recalls, regulatory enforcement, and government

litigation” (Peterson, 2006, p.1).

Benefits To Employees

• Training in the workplace, is to supply all workers with the opportunity to learn

beyond what they currently know, not only to ensure they are competent in

their current positions but provide them with opportunity to advance into new,

more beneficial positions.

• Training at work greatly benefits new employees, assisting them in feeling a

sense of belonging and being part of the new work community.

• Providing employee training is one way organizations can encourage a positive

and engaging work culture. It is, in some respects, common sense: Provide

people with an opportunity to advance beyond what they currently are tasked

with and the results will be beneficial for all involved.

• Enhancing an employee’s skills, capabilities and knowledge improves not just

their efficiency and productivity for doing the tasks required, but can also save

their life. There well trained workers will often exhibit efficiency, awareness

and safe work practices.

Benefits To Employees

• The training process benefits the employees because it moulds critical thinking

and leads to quality performance.

• Training can benefit employees by providing them with safe work practices and

skills and knowledge to do their job.

• Training in the workplace does result in a more productive workplace, as seen

in 18 case studies throughout the United States of America, with the National

Safety Council documenting the research: “The 18 case studies demonstrated

average gains of 66% in productivity, 82% in the safety records, 71% in cost

efficiencies, and 44% in quality, these numbers may not be realistic

expectations in other scenarios where safety initiatives are implemented”

(Maudgalya et al., 2008, p. 171).

Benefits To Employees

• Financial gain is one obvious benefit obtained from workplace training, as wages can increase

as result of it. For example, “the military offers training in a wide variety of skills and many are

very useful in the civilian sector. Training is provided during part or all of the first enlistment

period and used during the remainder of the first period and hopefully during subsequent

periods” (Becker, 1975, 25).

• On-the-job training and formal educational opportunities offered through the military provide

workers with valuable skills not only required for their military positions, but also for work

opportunities outside the military.

• Providing employee training is a way organizations can encourage a positive and engaging work

culture by involving them in more than required work. Maurer & Lippstreu (2008) discuss that

“employees are favourably disposed toward an organization to the extent that the organization

provides something valuable to the employees. When an organization provides something

valuable such as support for employee development, this should create a mindset in employees

that is positive toward the organization” (p. 329). It is, in some respects, common sense: provide

people with an opportunity to advance beyond what they currently tasked with and the results

will be beneficial for all involved.

•

Action PlanWhat will be done and

how?

By Whom? When? Performance

Indicator

Hire a designated trainer

for each department,

internal employees if

possible. Designate

supervisors or team leads

to be back-up trainers.

Will do the training of new

people and cross-training.

Hire an internal employee

temporary for revising and

developing SOPs.

Directors

Supervisors

Human

Resources

This task will need

to be done

immediately

The success of the

qualified trainers

will be measured by

the performance of

the new employees

on shift. This will

lead to a increase in

employee moral and

contentment and

increased production

levels.

Train the designated

trainers on what needs to

be covered when training

employees.

Supervisor

Main Trainer

Should be done as

soon as trainers are

hired.

The success of the

trainers will be

measured by their

own performance

and how it reflects

on the other

employees.

Action PlanWhat will be done and how? By Whom? When? Performance

Indicator

Identify who will need to be cross-

trained. Designate one person from

each shift.

Determine who is interested in

being cross-trained and qualified.

Supervisors

Team Leads

Immediatel

y after

trainers are

hired.

Success will be

measured by

employees ability to

perform multiple tasks

effectively.

Develop a training schedule where

employees are trained in a certain

order- low level to high level tasks.

Then develop a online training

checklist so that employees can

sign off tasks after completed and

there is a record of this.

Develop a training schedule for

cross-training.

Trainers

Supervisors

Immediatel

y after

trainers are

hired.

2-3 weeks

to

implement.

Well trained

employees will be an

indicator that these

tasks have been

successfully

implemented.

Will ensure new

employees have a

consistent training and

a record of the training

to determine any gaps

so that a gap analysis

can be performed.

Action PlanWhat will be done

and how?

By Whom? When? Performance

Indicator

Revise and update

SOPs to include

new equipment and

procedures.

Remove any SOPs

that are outdated.

Develop SOPs on

how the training

will be developed,

delivered,

maintained and

evaluated. Will

have to use current

SOPs for ongoing

training until

complete.

Human Resources

Employees

Supervisors

Directors

Start immediately

after the person is

hired for the

project.

2-3 months to

complete starting

with training SOPs.

Will ensure the

standardization of

training.

Training SOPs will

define exactly what

is needed to

complete training.

When SOPs are

clear and easy to

understand but

detailed enough to

perform the

procedure the task

has been successful.

Action Plan

What will be done

and how?

By Whom? When? Performance

Indicator

Develop a

questionnaire to

assess the

effectiveness of the

training for all

involved.

Supervisors

Human Resources

Will be completed

after the first round

of training has gone

through.

Will determine how

the training

program was

received by

everyone involved

and what can be

changed.

Barriers and Constraints

Barriers Potential Solutions

Trainers not being able to communicate

the information properly to trainees.

Ensure that trainers hired are not only

experienced and knowledgeable but able

to communicate that knowledge (not

everyone can be a good teacher)

(Bringslimark, 2004, p. 46).

When training of the trainers takes place

tips and techniques for effective teaching

can be provided.

Employees unwilling to be cross-trained. Provide employees with incentives to try

and learn new positions.

Identify what employees are interested in

cross-training before making selections.

Trainers teaching their own bad habits or

not all the procedures necessary for the

job.

Using the SOPs and training schedule will

ensure that training is standardized and

everyone get the same training (Gough

and Hamrell, 2009. p. 70).

Barriers and Constraints

Barriers Potential Solutions

Employees currently in positions might

feel their jobs are not secure with cross-

training.

Reinforce that this is a back-up plan for

when someone is out sick or on vacation

and are not permanently replacing people

on a shift.

Who should be hired for training, internal

or external employees?

Internal employees would be the best

choice as they are knowledgeable about

the procedures and operations of the

company. They should be a Subject

Mater Expert (SME) and 2-3 years of

experience (Akyar, 2012, p. 374).

How to account for shortages on a shift

when employees are being cross-trained?

Training may have to occur at times

when production is slow. Cross-training

can occur concurrently with training of

the new employees if learning the same

procedures. Possibility of paying

overtime to get employees to come in on

their days off if there is a need.

Barriers and ConstraintsBarriers Potential Solutions

Employees resistant to the implementation

of the new training program.

Involving the employees in the

development of the training program will

address problems that they see and may

be missed by leads and supervisors.

Getting employees feedback after

training will also reduce resistance to

training. Research and studies “suggest

that by paying close attention to the

evaluation of program effectiveness,

organizations end up with a more

effective program.” (Ng &

Dastmalchian, 2011, p. 838) Integration

of feedback the best way not only to

ensure learner comprehension, but to

improve upon the training program in

place.

Outcomes

• New employees will be well trained and existing employees will have

well trained employees on their shift, both leading to increased production

levels for the company and increased morale and contentment for the

employees.

• Having an effective training program will allow Biotech Pharmaceuticals

the ability to produce new drugs for new and existing clients.

• Well trained employees and properly used SOPs ensure that operations at

the company are in compliance with regulation by Health Canada and will

make audits run smoothly.

• By complying with regulations set by Health Canada it will allow

shareholders to put their trust in Biotech Pharmaceuticals by either putting

more money into the company and/or new clients to build the same trust.

Conclusion

In conclusion:

•Cross-training is vital for an organization and employee success, it is not

only a functional tool but one “which could provide psychological and

communicative enhancements for the employees and management of the

modern organization” (Wesner, 2014, p.12).

•Standard Operating Procedures (SOPs) ensures standardization of the

tasks being performed, as well as, accuracy and precision of results, thus

increased quality and compliance to Health Canada’s regulations (Akyar,

2012, p. 369).

•Therefore, SOPs in all training across the board, including cross-training

is essential for any company to use, especially pharmaceutical companies

that require new products to be delivered to both new and existing clients

in order to be financially stable.

Conclusion

In Conclusion:

•Qualified trainers will pass on their experience and expertise, not bad

habits and misunderstandings, thus allowing employees to get consistent,

standardized training (Illeris, 2011, p. 78).

•Employees will benefit from workplace training as it provides an engaging

and positive work culture, helps them advance into new positions, develop

new skills and safe work practices.

•All of which will lead to an well functioning workplace in compliance

with Health Canada’s regulations, and the ability to grow to produce new

drugs for new and existing clients.

References

Akyar, I. (2012). Standard Operating Procedures. What are they good for? In Latest research into

Quality Control (pp. 367-391). InTech Open Access.

Brewton, O., Culbreth, T., Groeger, H. (2011). Not your normal SOP.

Quality Progress, 44 (6), 24-28.

Bringslimark, V. (2004). If training is so easy, why isn’t everyone in compliance? Biopharm

International., 17 (1), 46.

Compliance Insight Inc (2012). Pharmaceutical training guidelines. Retrieved from http://compliance-

insight.com/wp-content/uploads/2013/03/20.020.2-Pharmaceutical- Training-Guideline-E-version1.pdf

Gough, J., Hamrell, M. (2009). Standard Operation Procedures (SOPs): Why companies must

have them, and why they need them. Drug Information Journal, 45, 69-74.

Illeris, K. (2011). The fundamentals of workplace learning. New York: Routledge.

Raelin, J. A. (2008). Work-based learning. San Francisco: John Wiley & Sons.

Robinson, K. (2003). GLPs and the importance of standard operating procedures. Biopharm International,

16 (8), 38-46.

Schniepp, S., J. (2011, June). Following our own instructions. Pharmaceutical Technology. Retrieved from

http://www.pharmtech.com/following-our-own-instructions

Sims, R. (2013). How to demonstrate training effectiveness to the FDA. Retrieved from

http://www.uleduneering.com/blog/index.php/2013/10/how-to-demonstrate-training- effectiveness-

to-the-fda/

References

Akyar, I. (2012). Standard Operating Procedures. What are they good for? In Latest

research into Quality Control (pp. 367-391). InTech Open Access.

Cancialosi, C. (2014). Cross-Training: Your Best Defense Against Indispensable

Employees. Retrieved from

http://www.forbes.com/sites/chriscancialosi/2014/09/15/cross-training-

your-best-defense-against-indispensable-employees/#1994f16b6303

Peterson, D. (2006). Assuring the effective use of Standard Operating Procedures (SOPs) in

today’s workforce. Retrieved from

http://www.biopharminternational.com/assuring-effective-use-standard-operating-

procedures-sops-todays-workforce?id=&sk=&date=&pageID=2

References

Becker, G., S. (1975). Human Capital: A theoretical and empirical analysis, with special

reference to education, Second Edition. New York: New York, National Bureau

of Economic Research, Inc.

Maurer, T., J., and Lippstreu, M. (2008). Who will be committed to an organization that

provides support for employee development? Journal of Management

Development, 27(3), 328-347.

Maudgalya, T., Genaildy, A., and Shell, R. (2008). Productivity - quality- costs- safety: A

systematic review of the national safety councils: Case studies in safety and

productivity. Human Factors and Ergonomics in Manufacturing, 18(2), 152- 179.

Ng, I., Dastmalchian, A. (2011, February). Perceived training benefits and training bundles:

A Canadian study [Abstract]. The International Journal of Human Resource

Management, 22(4), 829-84