Standard Operating Procedures (SOPs): How Companies Can Determine Which Documents They Must Put in Place
- PDF / 6,789,361 Bytes
- 6 Pages / 602.399 x 783.6 pts Page_size
- 106 Downloads / 253 Views
49
Standard Operating Procedures (SOPs): How Companies Can Determine Which Documents They Must Put in Place
Janet Gorgh, MA Consultant. Flanders. New jersey
Micbael Hamrell, PbD MORlAH Consultants, Yorba Linda, California
Key Words SOP; Compliance; Procedure Correspondence Address Janet Cough (email: [email protected]).
lhis is the second of three articles on standard opemting procedures or SOPs. It addresses what SOPs an organization needs to think about and how to determine what SOPS to put in place. f i e last article will describe how to write SOPS in clear;concise language so that processes and activities occur as they are supposed to. l%efirst article addressed the need for SOPS and their value to the business unit. SOPs are
INTRODUCTION During an audit of a biotech company by a POtential partner, an auditor was puzzled by the lack of standard operating procedures (SOPs) for the quality unit. "We don't have SOPs because the regulations are very clear as to what we need to do, and in essence we do it," the director of quality declared when the auditor questioned the apparent lack. "There's nothing to be gained by taking the regulations and putting them into our own documents." This director was perhaps woefully misinformed. Companies must have procedures, because the Code of Federal Regulations (CFR) and other applicable regulations say they must. The regulations provide general requirements of what companies must do, but SOPs show how individual companies comply. Lack of understanding of what SOPs need to be in place is one area in which some companies fall short (1). While most companies recognize the need for SOPs and have them in place, some fail to put essential SOPs into their systems because they do not think the SOPs apply. Consider the case of a small generic manufacturer whose vice president of quality assurance was proud of the standard of compliance. When a consultant did a gap analysis of the SOPs, she found that the company had no provision for a recall. "We op-
the first line of defense in any inspection, whether it be by a regdatory b+, a partner or potential partna a client, or a firm conducting due diligence for a possible purchase. It does not matter what a company calls them; any document that is a "how to"falls into the category of procedures. SOPS in fact define expected pmctices in all businesses where quality standards exist.
erate so well, we will never have a recall," the vice president said, "so we don't need that SOP." While pride in operations is a good thing, and it may well be that the company will never have a recall, the company still needs to anticipate the possibility and put a procedure in place (2). Companies also fall short when they fail to recognize the wisdom of putting SOPs in place that the regulations do not necessarily require. Consider the biotech that hired a new statistician. Shortly after she came on board, she dashed off an abstract for a conference in Hawaii. Unfortunately, the abstract disclosed some proprietary information that should not have be
Data Loading...
