• Does it feel like everything is in a state of chaos?
• Are personnel frequently looking for someone to show them how to do something?
• Do you benchmark customer satisfaction?
• Do you know your cost of quality (e.g., nonconformance, product returns, rework, customer complaints)?
• Have you documented objectives for the business and your product or service offering? Are they routinely tracked?

If you have to think hard about any of these questions, then your Quality Management System (QMS) is most likely suffering and it is not meeting specified API Spec Q1 requirements. If you are not meeting these requirements, your processes, business and quality alike are not receiving sufficient inputs to be optimized; in short, you are losing money. That is correct, you are losing money! Time, movement, throughput and efficiency are all examples of impacts upon cost.

How do you begin to understand the requirements posed by your QMS? To start, you might want to review your process requirements. In order for a business to be effective, all processes should be mapped out and the minimum requirements for the individuals involved in the processes should be identified. Also known as job performance* requirements these processes are essential to meet known process output.

Let's analyze API Spec. Q1, clause 6.2 requirements as they apply to the subject of competency.

Q1, clause 6.2.1, General, states "Personnel performing work affecting quality shall be competent on the basis of appropriate education, training, skills and experience".

In order to determine competency* the requirements for education, training, skills and experience should be clearly spelled out and included in job descriptions through qualitative* and quantitative* information. There are other places this information can be maintained, but job descriptions; on a per position basis, is a tidy way of maintaining the information.

Job descriptions should parallel the need to effectively maintain business and QMS processes; more specifically, the job descriptions should identify the minimum requirements for the processes and responsibilities an individual will be assuming. Anything less will most likely introduce error (risk) into the process, which may result in rework or mishaps. If you are fortunate, you will notice it early on in the process. Depending upon the timing and the error introduced, it may not be noticed until a product is completed or a service has been delivered.

Through the documentation of clear job descriptions the basic individual and job requirements are spelled out, thus insuring a starting place for individual continuity as it relates to process continuity.

Q1, clause 6.2.2, Competence, awareness and training, states: "The organization shall: (a) determine the necessary competence for personnel performing work affecting the product".

As we stated under clause 6.2.1, competency requirements can be identified in job descriptions. Now we have to "determine" how personnel meet the specified "competency" requirements.

A process known as "qualification*" can be used. Qualification means that an individual, their resume, support documentation and/or follow-up verification of information contained on the resume are compared to the requirements of the job description to assess whether or not an individual can meet the requirements. If the individual can meet these requirements, the assessment should be documented and a statement that the individual is qualified to the job description requirements should be included.

Through the documentation of "how" individuals meet job description requirements, verification has taken place to approve personnel to act in a given function.

Q1, clause 6.2.2, Competence, awareness and training, states: "The organization shall: (b) provide training or take other actions to satisfy these needs".

If an individual does not fully meet the job description requirements, training should be documented to bring the individual up to the specified requirements. Depending upon the "gap" between the job description and the individual's capability*, as examples, the training could be an internal training course, an external training course, training courses moving towards an industry certification or on-the-job training. Depending upon the duration of the training, precautions to reduce the introduction of error should be taken to ensure that the individual is being properly supervised if they are allowed to work.

Additionally, training should be required:

• For initial familiarization with QMS requirements for each specific position
• When personnel change jobs
• When QMS requirements are revised
• If processes are modified or changed

Training should also include awareness of:

• The Quality Policy
• The relevance and importance of their activities and how they contribute to the achievement of the quality objectives
• The consequences to the customer of nonconforming products or services

Through training, personnel are brought up to speed to current QMS and/or process requirements and are advised of the importance of their position with respect to quality objectives and the potential impact to customers regarding nonconforming products or services.

Q1, clause 6.2.2, Competence, awareness and training, states: "The organization shall: (c) evaluate the effectiveness of the actions taken".

Once training is performed, personnel should be reevaluated to ensure they understand what the training was meant to convey. If any individual does not understand the training provided, then additional explanation and/or training should be provided.

Evaluation of an individuals' understanding after training is sometimes referred to as "post training competency" determination; as opposed to the "initial competency" determination discussed in Q1, 6.2.2 (a) above. Post training competency determination could be performed, as examples, through:

• An examination or quiz
• The performance of an audit
• Witnessing of an individual's job performance based upon the documented QMS requirements
• The monitoring of process nonconformances (e.g., providing trend analysis of nonconformities is documented)

Through periodic evaluation of training effectiveness, personnel are monitored to ensure individual continuity.

Q1, clause 6.2.2, Competence, awareness and training, states: "The organization shall: (d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives".

This subject is discussed in 6.2.2 (b); however, the achievement of quality objectives can be better realized if results of trend analyses are routinely performed, posted and reviewed with personnel as they apply to the activities being performed.

Through periodic reinforcement, personnel are advised, as needed, of areas needing improvement.

Q1, clause 6.2.2, Competence, awareness and training, states: "The organization shall: (e) maintain appropriate records of education, training, skills and experience (see 4.2.4)".

The records identified below include more information than required by API Spec. Q1, clause 6.2.2. Additionally, optional records have been identified to allow for future planning and QMS process documentation.

Records could include:

• Information related to where the job description requirements came from (e.g., API Spec. Q1, clause 7.1, Planning of product realization)
• Superseded versions of job descriptions
• Results of verifications related to personnel resume content
• Documentation of personnel through the personnel qualification process, including any identified gaps
• The resulting qualification record
• Training performed
• Training effectiveness determination

Through the retention and maintenance of detailed records (1) evidence of QMS compliance can be demonstrated (2) evidence of regulatory compliance, where applicable, can be demonstrated (3) future training and job modifications can be planned.

*Definitions (The way we see it):

Is compliance to external standards referenced by an API Product Specification required?

The short answer is most likely, but to find out for sure, evaluate the products you are manufacturing. If an external standard is identified for your product type; then yes, you have to comply with the requirements. API Product Specifications identifies Normative References; usually in Section 2 of most specifications. Shown below is the typical wording extracted from one of the product specifications:

By nature, the word "normative" in standardization activities means that the references are required.

For most product specifications, Normative References are located in Section 2. Others in may be referenced in Section 3 and possibly elsewhere. Some specifications may not have a "Normative Reference" section, but merely make reference to external standards throughout the body of the specification.

What year of external standards should I use?

Where a specific year of the standard is identified by an API Product Specification, the year specified is also required to be. However, if a year is not specified, then the "latest" revision of the external standard is required to be used along with any addenda.

External standards can be costly and difficult to manage depending upon how many you are required to have to meet API Product Specifications applicable to your facility. Standards can be purchased from publishers directly or through companies such as Techstreet (http://www.techstreet.com/) or the IHS Standards Store (http://global.ihs.com/).

It's helpful to purchase standards through a standards company since they will inform you when specific standards are revised. The way the Normative Reference language is worded ("the latest edition of the referenced document (including any amendments) applies") you are required to maintain the current copy.

So, as long as I have the reference standards, I am in compliance; correct?

No, you also have to comply with the contents of the external standards in order to meet API Product Specification requirements. This also means the qualification of personnel and maintenance of any record requirements the standards identify.

Does Q1, clause 4.2.3 apply to external standards?

Yes, the external standards are required to be placed on the Master Document List.