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David Dills

Writing and Enforcing Your SOP for GxP Compliance Success - Part 2
by David R. Dills, Quality & Compliance Advisor


Jan 31, 2012 | Free Downloads | email | Print

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View Part 1 of this article.

Developing SOP Skills

Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

Avoid words that cause ambiguity. Words such as "periodically," "generally," "may," "should," and "can" typically indicate a preference and do not enforce consistent execution.

Terms like "must," "shall," and "will" indicate steps within a procedure that must be adhered to exactly with each execution. Avoid words that cause ambiguity. Words such as "periodically," "generally," "may," "should," and "can" typically indicate a preference and do not enforce consistent execution.

Conversely, document format and organization of your procedures and forms can lead to ease of use in the maintenance of records, which results in greater accuracy. Procedures should always follow a predetermined format. Encourage employees to use templates by making them available and easily accessible.

Nonetheless, in order to have a robust and healthy SOP system, several key elements are involved in creating a document change control system. A good system ensures that the correct people review and approve documents (approvals should be defined by document category and level of personnel and should be cross-functional and departmental).

It also ensures that change occurs when needed, and not on a periodic basis (unless required procedurally or driven through other standards). Control of distribution and retrieval ensures that only the current, approved versions of documents are available for use.

"It can't be so detailed that if you make any process changes at all, you're completely out of compliance."

Another way companies write themselves out of compliance is by not having the resources to implement an SOP. I often find companies don't focus on resources. Companies will add that part of the drafting and approval process to ensure the necessary resources are available. Not following existing SOPs may be viewed as worse than not having written SOPs.

Therefore, your benefits should be quite apparent.

Benefits

  • Compliance
  • Consistency
  • Continuity
  • Quality Assurance
  • Responsibility
  • Control
  • Confidence
  • Empowerment - Personnel

Ten Reasons to Have SOPs

  1. Because they help people to focus on specific activities that lead toward goal achievement.
  2. Because they improve communication and teamwork among workers, management, and advisors.
  3. Perpetuation of "best practices."
  4. Because variation can be very costly.
  5. Because you can't make changes until you have control of the system.
  6. Because training is much easier with SOPs than without.
  7. Because it's tough to give good feedback when it's not clear what you want.
  8. Because many workers today have previous (differing) experience from past employers.
  9. Because many workers today don't have previous experience.
  10. Because they help temporary workers and contractor to do the job right.

Ten Reasons for Not Having SOPs

  1. The "Blame Game"
  2. Too much time
  3. Too much trouble
  4. We can't agree
  5. No accountability
  6. Creativity is more fun
  7. My way is best
  8. We can all have our own special processes
  9. More flexibility in performance reviews
  10. If you have them, you have to follow them

How Much Detail

The minimal amount of detail should include:

  • Critical "what's"
  • Critical "how's"
  • The "who's" if more than one person is involved. Remember, not all SOPs in an organization need the same level of detail.

Does your procedure involve many decisions and steps? This will help determine suitable and ideal format.

Many decisions?More than 10 steps?Best SOP format
No
No
Simple Steps
No
Yes
Hierarchical
Yes
No
Flowchart
Yes
Yes
Flowchart

How do you Handle Overcoming Resistance?

  • "We've done it just fine the way we've always done it before!"
  • "This is no benefit to me, just extra work!"
  • "The boss wants to micro-manage everything we do."

Problems

  • Fear of Change
  • WIIFM (What's in it for me?)
  • Lack of empowerment

Solutions

  • Explain need for change and listen to concerns. Communication!
  • Share mission and values of the business. Explain how improvement benefits everyone.
  • Encourage people to take an active role in shaping change and improving quality.
  • FDA/law and injury/death associated with product

SOPs must be a true reflection of what is actually being done. If not, change the process or change the SOP. Often the failure of an SOP or a collection of SOPs originates from the technical shortcomings of the SOPs and the following depressing list shows why staff might resist using SOPs:

  • The required SOP is difficult to locate in the total collection of SOPs
  • The SOP is written in foreign language
  • The SOP is written in language difficult to follow
  • Instructions and general information are mixed
  • The procedure is described in an unfamiliar way
  • The user knows another (better) method, or can do the procedure in ‘his/her sleep’

Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.

There is no federally approved format for a SOP but there are expectations within the industry, i.e., FDA regulated industry, on how a SOP should be written.

Therefore, the SOP is written in imperative sentences rather than a narrative style. A cookbook format is used and sentences should start with a task specific verb that tells what to do. The instructions are numbered in the order that they will be followed. Writing detailed procedures and developing document management systems seem tedious and, for many, are not core competencies.

Procedures are the cornerstone of a strong quality system; they provide infrastructure and are the backbone of Quality Management System. Inspectors will audit processes against approved procedures. The development and use of SOPs are an integral part of a successful quality system. They provide information to perform a job properly and correctly, and consistently in order to achieve a pre-determined specification and quality end-result.

Creating appropriate procedures eliminates the need for interpretation by employees and ensures that procedures are being followed as intended. They allow for consistency of business process execution, thus limiting inspectional findings, product liability, and recalls. Manufacturers should use good judgment when developing their quality system and apply those sections of the QS regulation or even 21 CFR 210/211 that are applicable to their specific products and operations.

The same rationale applies to how you develop, execute and enforce your SOPs. In most cases, it is left to the manufacturer to determine the best methods to attain quality objectives. In some cases, however, the QS regulation does specify the particular type of method to be used, such as written procedures or written instructions. This does not mean, however, that manufacturers cannot vary from the method specified if the intent of the GMP requirement can be met by another method.

In summary, both developing procedures and controlling them force managers and management in general to think about how change might affect production, materials, supplier, equipment, and validation, and certainly the patient and end-user. MasterControl produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. The solutions securely manage your company's critical information and the documentation process throughout the entire product lifecycle.



David R. Dills is an independent Regulatory & Compliance consultant with an accomplished record. Dills has more than 22 years of hands-on experience with emphasis on Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA, Regulatory Affairs and Compliance. Since 2000, Dills has provided consultative services on behalf of manufacturers, has subcontracted for third-party consultancies and has provided services involving all key stages of the product development; submissions; commercialization process; inspection readiness preparation; GxP compliance; audits/assessments; remediation/regulatory strategies; postmarketing surveillance and vigilance reporting; clinical affairs; deployment and remediation; Quality Management; documentation systems; software validation; ISO 13485; CE Mark; and multi-country product registrations. He has been previously employed by medical device firms and consultancies, including a globally recognized CRO.

Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute and currently serves on the Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was accepted for inclusion into the 2005-2006 Strathmore's "Who's Who" of Professionals. Dills has published validation, regulatory and compliance-related articles and is an accomplished global industry presenter. Mr. Dills’ academic degrees include studies in Environmental Science and Biology. He is a former Chair and Co-Chair of ASQ’s Section 1506 and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups. Contact him at drdills@bellsouth.net.


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